Each year, millions of consumers use pain relievers to treat everything from back aches to symptoms associated with the common cold. Some estimates place the number as high as 48 million in a given week. But as with all medications, products containing acetaminophen, aspirin or ibuprofen should be used with care. Exceeding the recommended daily dose can jeopardize the consumer's recovery and pose real health problems. Recently, the Food and Drug Administration (FDA) has proposed that the most popular pain relievers carry additional warnings on their labels that overuse may result in stomach bleeding or liver and kidney damage.
"It is important for consumers to remember that products containing acetaminophen and some of these other nonsteroidal anti-inflammatory drugs are safe and effective when used properly," said Past APhA President Dr. Jan Engle. "Pharmacists and other healthcare providers always emphasize to patients that they should know the ingredients in all of their medications, including those they buy over the counter. If a patient is concerned that they might be overmedicating, they should speak with their doctor or pharmacist immediately."
APhA recommends the following for consumers who may be taking a pain reliever regularly:
-- Read the label, Follow the Directions -- Consumers should always know which active ingredients are in the products they are using and follow the recommended dose. Do not exceed the recommended daily dose and do not take the medication for longer than directed.
-- Know Your Medicine, Talk to Your Healthcare Provider -- You should not only know the name of your medication, but the common ingredients as well. A consumer survey commissioned by APhA last year confirmed that only 55% of consumer knew the active ingredients of their prescription medicine. Consumers need to 'know their medicine' - many of the most common prescription and over the counter pain relievers and cold treatments contain similar ingredients, which could result in overmedication. If consumers have questions, they should talk to their pharmacist or doctor.
-- Over the counter pain relievers are safe when used as directed on the label -- When used as directed, over the counter pain relievers are safe. People should not stop taking prescribed pain relievers without first consulting their physician.
-- Talk to your pharmacist about over the counter pain medications. Your pharmacist can help you choose the best product for your condition.
The American Pharmacists Association is dedicated to improving medication use and advancing patient care. Founded in 1852 as the American Pharmaceutical Association, APhA is the first established and largest professional association of pharmacists in the United States. APhA's more than 57,000 members include pharmacists, scientists, student pharmacists, pharmacy technicians, and others interested in advancing the profession.
American Pharmacists Association
http://www.aphanet.com/
April 16, 2007
Chiropractic Resolutions For A Healthy, Pain-Free Year
Start the new year off right by committing to a healthier lifestyle. A few simple and practical lifestyle changes can make a positive impact on your health and can also prevent you from experiencing a painful injury in the year ahead, according to the American Chiropractic Association (ACA).
The ACA and your local doctor of chiropractic urge you to adopt the following New Year's resolutions for a healthier 2007.
1) I will limit my intake of caffeinated coffee, sodas and teas. The caffeine in these drinks can cause dehydration and can rob the body of essential nutrients. Stick to water, natural juices and other decaffeinated beverages.
2) I will avoid over medicating myself and my family. Many over-the- counter and prescription medications have unknown side effects. Discuss alternative remedies with a doctor of chiropractic.
3) I will not carry a heavy purse or briefcase with its strap over my shoulder, unless I place the strap over my head on the side opposite the bag. Wearing a shoulder strap over one shoulder unevenly places the weight of the bag on one side of the body, potentially causing shoulder and back pain.
4) I will not allow my children to carry backpacks that weigh more than 10 percent of their body weight. Beyond that weight, the backpack can cause the wearer to bend forward in an attempt to support the weight on his or her back, instead of the shoulders.
5) I will not lift heavy objects over my head. These types of movements can strain muscles and affect nerves, causing severe neck, shoulder and arm problems.
6) I will not turn my torso while lifting relatively heavy objects. This rotates the spine and can bring on a "back attack."
7) I will avoid the habit of consistently crossing the same knee over the other. Such a habit can also eventually cause misalignment of the spine.
8) I will try to keep moving while I'm at work. If sedentary for the majority of the work day, it is very important to take periodic stretch breaks. Get up from the desk and take a brief walk, and stretch arms and legs as frequently as possible to avoid postural and spinal stress.
9) I will, when using a shovel - in winter or summer - remember to push rather than lift, whenever possible.
10) I will use luggage with wheels whenever possible. Carrying, lifting and moving a heavy suitcase can ruin a vacation.
For more information on chiropractic care, or to find a chiropractor near you, visit ACA's Web site at: http://www.acatoday.org.
American Chiropractic Association
http://www.acatoday.com/
The ACA and your local doctor of chiropractic urge you to adopt the following New Year's resolutions for a healthier 2007.
1) I will limit my intake of caffeinated coffee, sodas and teas. The caffeine in these drinks can cause dehydration and can rob the body of essential nutrients. Stick to water, natural juices and other decaffeinated beverages.
2) I will avoid over medicating myself and my family. Many over-the- counter and prescription medications have unknown side effects. Discuss alternative remedies with a doctor of chiropractic.
3) I will not carry a heavy purse or briefcase with its strap over my shoulder, unless I place the strap over my head on the side opposite the bag. Wearing a shoulder strap over one shoulder unevenly places the weight of the bag on one side of the body, potentially causing shoulder and back pain.
4) I will not allow my children to carry backpacks that weigh more than 10 percent of their body weight. Beyond that weight, the backpack can cause the wearer to bend forward in an attempt to support the weight on his or her back, instead of the shoulders.
5) I will not lift heavy objects over my head. These types of movements can strain muscles and affect nerves, causing severe neck, shoulder and arm problems.
6) I will not turn my torso while lifting relatively heavy objects. This rotates the spine and can bring on a "back attack."
7) I will avoid the habit of consistently crossing the same knee over the other. Such a habit can also eventually cause misalignment of the spine.
8) I will try to keep moving while I'm at work. If sedentary for the majority of the work day, it is very important to take periodic stretch breaks. Get up from the desk and take a brief walk, and stretch arms and legs as frequently as possible to avoid postural and spinal stress.
9) I will, when using a shovel - in winter or summer - remember to push rather than lift, whenever possible.
10) I will use luggage with wheels whenever possible. Carrying, lifting and moving a heavy suitcase can ruin a vacation.
For more information on chiropractic care, or to find a chiropractor near you, visit ACA's Web site at: http://www.acatoday.org.
American Chiropractic Association
http://www.acatoday.com/
'Botox' Can Ease Writer's Cramp
Botox"' the popular anti- wrinkle treatment, can also ease writer's cramp, suggests a small study published ahead of print in the Journal of Neurology Neurosurgery and Psychiatry.
Writer's cramp describes the painful involuntary, spasmodic muscle contractions of the fingers, hand, or arm during writing. But it can also occur during other manual tasks.
Some people learn to write with their other hand, but in one in four cases, the condition affects both hands, and the condition is difficult to treat. It affects around three to seven in every 100,000 people.
Relaxation techniques, hypnosis, biofeedback, acupuncture, and 'writing re-education exercises' have all been used, but none of these brings sustained relief. And there is as yet no effective drug treatment.
Forty people with writer's cramp were randomly assigned to a course of injections containing either botulinum toxin (botox) or a dummy substitute in two doses, usually into two muscles, over a period of 12 weeks.
Of the 20 people given botox treatment, 14 (70%) said that their condition had significantly improved, and that they wished to continue treatment. Their improvement was confirmed using validated disability and pain scales.
Only six of the 19 people in the dummy group felt that their condition had improved. One person dropped out of the trial.
One person who received the dummy injection at the first session and botox at the second, also registered an improvement in symptoms.
After a year, half of the trial participants were still receiving botox injections, and were finding them helpful.
Side effects included mild and temporary muscle weakness and pain at the injection site. Symptom relief lasted from three to 18 months, with an average symptom free period of four and a half months.
###
Contact: Emma Dickinson
BMJ Specialty Journals
Writer's cramp describes the painful involuntary, spasmodic muscle contractions of the fingers, hand, or arm during writing. But it can also occur during other manual tasks.
Some people learn to write with their other hand, but in one in four cases, the condition affects both hands, and the condition is difficult to treat. It affects around three to seven in every 100,000 people.
Relaxation techniques, hypnosis, biofeedback, acupuncture, and 'writing re-education exercises' have all been used, but none of these brings sustained relief. And there is as yet no effective drug treatment.
Forty people with writer's cramp were randomly assigned to a course of injections containing either botulinum toxin (botox) or a dummy substitute in two doses, usually into two muscles, over a period of 12 weeks.
Of the 20 people given botox treatment, 14 (70%) said that their condition had significantly improved, and that they wished to continue treatment. Their improvement was confirmed using validated disability and pain scales.
Only six of the 19 people in the dummy group felt that their condition had improved. One person dropped out of the trial.
One person who received the dummy injection at the first session and botox at the second, also registered an improvement in symptoms.
After a year, half of the trial participants were still receiving botox injections, and were finding them helpful.
Side effects included mild and temporary muscle weakness and pain at the injection site. Symptom relief lasted from three to 18 months, with an average symptom free period of four and a half months.
###
Contact: Emma Dickinson
BMJ Specialty Journals
Workers' Compensation Ratings Don't Accurately Predict Disabilities
A study of settlement decisions in workers' compensation claims for low back pain has found almost no relationship between the rating of the disability's severity when the claim was settlement and reported pain and disability 21 months later.
Findings were counterintuitive: Claimants with higher disability ratings, which suggest higher severity and less ability to work, fared better than those with lower ratings.
The study shows that "administrative decisions made at the end of the workers' compensation claim process about the ability of someone to work after back injury has very little predictive validity," said Dr. Norton Hadler, a professor of medicine and microbiology/immunology in the University of North Carolina at Chapel Hill's School of Medicine.
Hadler is a co-author of the paper, which was published in the December issue of the Journal of Pain, with colleagues from St. Louis University and the University of Florida. It was based on administrative records in Missouri of workers' compensation claims for low back pain.
Workers' compensation is an important part of America's health-care system, accounting for 3 percent of an employer's gross income, Hadler said.
"Clearly, the rating schemes for workers' compensation are inconsistent, and that fact is stirring enormous pots across the country," Hadler said. "If the outcomes from Missouri generalize, then there is a need to reform how disability is determined."
Another paradoxical finding showed that white claimants faired no better than blacks, even though previous reviews found that blacks were much less likely than whites to be diagnosed with a herniated disk or to have back surgery, had less money spent on their care and received lower disability ratings and smaller settlements.
"It's one of the more perverse observations in our study," said Hadler. "African-Americans were much less likely to be operated on, but the care that the whites got, even though it looks like more care, because it's surgery and it's more expensive, didn't do anything for them."
For their study, the researchers interviewed 580 black and 892 white workers' compensation claimants an average of 21 months after claim settlement to assess how well they were functioning and to determine the contribution of impairment, race and socioeconomic status to their disability ratings.
Hadler said that workers' compensation claims for low back pain represent only 20 to 30 percent of all claims filed but consume a majority of the workers' compensation budget.
The article concludes that "the pattern of results suggests that race/ethnicity and other sociodemographic factors influence medical decision making and … the outcomes of medical care." Furthermore, the flaws in the system "are not distributed evenly" but "are visited disproportionately" on minorities and persons of lower socioeconomic status.
Study collaborators were Drs. John T. Chibnall and Raymond C. Tait from Saint Louis University School of Medicine and Dr. Elena M. Andresen of the University of Florida. Tait was the study's principal investigator and lead author of the article. It is the fifth article that the quartet have published over the last two years.
University of North Carolina at Chapel Hill
210 Pittsboro St. Campus Box 6210
Chapel Hill, NC 27514
United States
http://www.unc.edu/
Findings were counterintuitive: Claimants with higher disability ratings, which suggest higher severity and less ability to work, fared better than those with lower ratings.
The study shows that "administrative decisions made at the end of the workers' compensation claim process about the ability of someone to work after back injury has very little predictive validity," said Dr. Norton Hadler, a professor of medicine and microbiology/immunology in the University of North Carolina at Chapel Hill's School of Medicine.
Hadler is a co-author of the paper, which was published in the December issue of the Journal of Pain, with colleagues from St. Louis University and the University of Florida. It was based on administrative records in Missouri of workers' compensation claims for low back pain.
Workers' compensation is an important part of America's health-care system, accounting for 3 percent of an employer's gross income, Hadler said.
"Clearly, the rating schemes for workers' compensation are inconsistent, and that fact is stirring enormous pots across the country," Hadler said. "If the outcomes from Missouri generalize, then there is a need to reform how disability is determined."
Another paradoxical finding showed that white claimants faired no better than blacks, even though previous reviews found that blacks were much less likely than whites to be diagnosed with a herniated disk or to have back surgery, had less money spent on their care and received lower disability ratings and smaller settlements.
"It's one of the more perverse observations in our study," said Hadler. "African-Americans were much less likely to be operated on, but the care that the whites got, even though it looks like more care, because it's surgery and it's more expensive, didn't do anything for them."
For their study, the researchers interviewed 580 black and 892 white workers' compensation claimants an average of 21 months after claim settlement to assess how well they were functioning and to determine the contribution of impairment, race and socioeconomic status to their disability ratings.
Hadler said that workers' compensation claims for low back pain represent only 20 to 30 percent of all claims filed but consume a majority of the workers' compensation budget.
The article concludes that "the pattern of results suggests that race/ethnicity and other sociodemographic factors influence medical decision making and … the outcomes of medical care." Furthermore, the flaws in the system "are not distributed evenly" but "are visited disproportionately" on minorities and persons of lower socioeconomic status.
Study collaborators were Drs. John T. Chibnall and Raymond C. Tait from Saint Louis University School of Medicine and Dr. Elena M. Andresen of the University of Florida. Tait was the study's principal investigator and lead author of the article. It is the fifth article that the quartet have published over the last two years.
University of North Carolina at Chapel Hill
210 Pittsboro St. Campus Box 6210
Chapel Hill, NC 27514
United States
http://www.unc.edu/
December Nursing News And Research Briefs
High Risk Patients Use Both Conventional Medicine and Alternative Therapies for Asthma; Some Alternatives Pose Risk In depth interviews with a group of low income mostly female African Americans, all of whom had severe asthma, revealed that all participants used some form of complementary and alternative medicine (CAM) in combination with conventional medicine. Writing in this month’s issue of the Journal of General Internal Medicine, Johns Hopkins University School Nursing researcher Maureen George, PhD, RN notes that "While most subjects trusted prescription asthma medicine, there was a preference for integration of CAM with conventional asthma treatment. CAM was considered natural, effective and potentially curative."
Among the reasons CAM was chosen as an addition to or substitute for conventional care were beliefs that treatment was "more natural" than manufactured agents; could reduce the need for conventional pharmacologic treatment such as steroids; provided protection from illness or for relief of systems; and offered some hope of a cure. While participants denied substituting CAM for prescription medication, most (63%) also reported they had not adhered to their conventional therapy in the two weeks prior to the interviews or that they had missed doses, some as many as ten or more.
The researchers also found that many participants did not disclose their CAM use to providers. When CAM therapies were preferred but covertly used, patients could be at increased risk for poor clinical outcomes due to drug-CAM interactions; unnecessary delays in seeking appropriate medical attention; and insufficient adherence to the patient’s medical plan leading to an unnecessary intensification of conventional therapies. George and colleagues also determined that some patients were using herbs and over-the-counter products in ways that could be harmful, including ingesting camphor-based or mentholated topical salves, dissolving cough lozenges as many as ten at a time in herbal tea, and taking Echinacea, an herb that could result in a worsening of asthma due to allergic reactions.
Studies Contribute to Better Understanding Pain, Reducing its Physical, Economic Consequences--Faculty member Fannie Gaston-Johansson, PhD, RN has, in collaboration with researchers at Goteborg University, Sweden, recently published two articles in BMC Nursing focusing on better understanding and managing pain.
In "Pain, psychological distress and health-related quality of life at baseline and three months after radical prostatectomy," Gaston-Johansson, notes that inadequate management of postoperative pain is common and is a risk factor for prolonged pain after surgery. In addition to medical and technical factors, psychological factors may also influence the experience of postoperative pain. The study found that patients who experienced the highest postoperative pain levels also had the longest hospital stay.
A second study examined unexplained chest pain (UCP), an increasing phenomenon often seen in Emergency Departments. In the article "Coping strategies, stress, physical activity and sleep in patients with unexplained chest pain" Dr. Gaston Johansson, examines coping strategies in patients with UCP and examines the relationships between these strategies, negative events, sleep problems, physical activity, stress and pain intensity.
In Other Nursing News:
David A. Thompson, DNSc, RN, and others published an article "Clinical and Economic Outcomes of Post-Operative Hospital Acquired Pneumonia in Patients who Receive Invasive Diagnostic Testing, and Ventilation" in the December issue of the "Journal of Clinical Outcomes Management." The article examines the clinical and economic impact of traditional technologies used in the diagnosis and management of intra-abdominal postoperative surgical patients who develop hospital acquired-pneumonia.
JHUSON doctoral student and clinical instructor Jason Farley MSN, MPH, CRNP, spent Thanksgiving in Namibia, Africa, working with the University of Namibia School of Nursing to complete a needs assessment for the 2007 implementation of a World Health Organization program “Integrated Management of Adolescent and Adult Illnesses.” The program supports a larger role for nursing personnel in developing countries in the care of persons living with HIV/AIDS.
Four JHUSON faculty members and doctoral students presented a variety of posters at the 134th Annual Meeting of the American Public Health Association (APHA) held in Boston, MA last month:
Rosemarie Brager, PhD, CRNP, presented "вЂ˜Guided Care’ for Multi-Morbid Adults," a model that infuses contemporary primary care with state-of-the-art information technology to help address the health care of multi-morbid older Americans in an often fragmented system lacking in quality and efficiency.
Joan Kub, PhD, APRN and SON students Jessica Williams Roberts, Sarah Joyce, Nina Fredland, and Colleen Thornton delivered posters focused on the increasingly recognized public health issue of bullying in the nation’s schools: "Bullying Victimization and Associated Health Outcomes in Elementary School Students," and "No Room for Bullying, an Intervention at a Local School."
Jodi Shaefer,PhD, RN presented “Fetal and Infant Mortality Review (FIMR): Promoting Culturally and Linguistically Competent Health Messages in Multi-Cultural Communities,” and research conducted by Robin Newhouse, PhD, RN, “Developing a Measure of the Impact of Legislation and Organizational Forces on Rural Hospital Nursing.”
The Johns Hopkins University School of Nursing is a global leader in nursing research, education and scholarship and is ranked among the top 10 nursing higher education institutions in the country. The School’s community health program is second in the nation and the nursing research program now holds eighth position among the top nursing schools for securing federal research grants. The School continues to maintain its reputation for excellence and educates nurses who set the highest standards for patient care, exemplify scholarship, and become innovative national and international leaders in the evolution of the nursing profession and the health care system. For more information, visit http://www.son.jhmi.edu/.
Johns Hopkins University School of Nursing
525 North Wolfe St, Rm 525
Baltimore, MD 21205
United States
http://www.son.jhmi.edu/
Among the reasons CAM was chosen as an addition to or substitute for conventional care were beliefs that treatment was "more natural" than manufactured agents; could reduce the need for conventional pharmacologic treatment such as steroids; provided protection from illness or for relief of systems; and offered some hope of a cure. While participants denied substituting CAM for prescription medication, most (63%) also reported they had not adhered to their conventional therapy in the two weeks prior to the interviews or that they had missed doses, some as many as ten or more.
The researchers also found that many participants did not disclose their CAM use to providers. When CAM therapies were preferred but covertly used, patients could be at increased risk for poor clinical outcomes due to drug-CAM interactions; unnecessary delays in seeking appropriate medical attention; and insufficient adherence to the patient’s medical plan leading to an unnecessary intensification of conventional therapies. George and colleagues also determined that some patients were using herbs and over-the-counter products in ways that could be harmful, including ingesting camphor-based or mentholated topical salves, dissolving cough lozenges as many as ten at a time in herbal tea, and taking Echinacea, an herb that could result in a worsening of asthma due to allergic reactions.
Studies Contribute to Better Understanding Pain, Reducing its Physical, Economic Consequences--Faculty member Fannie Gaston-Johansson, PhD, RN has, in collaboration with researchers at Goteborg University, Sweden, recently published two articles in BMC Nursing focusing on better understanding and managing pain.
In "Pain, psychological distress and health-related quality of life at baseline and three months after radical prostatectomy," Gaston-Johansson, notes that inadequate management of postoperative pain is common and is a risk factor for prolonged pain after surgery. In addition to medical and technical factors, psychological factors may also influence the experience of postoperative pain. The study found that patients who experienced the highest postoperative pain levels also had the longest hospital stay.
A second study examined unexplained chest pain (UCP), an increasing phenomenon often seen in Emergency Departments. In the article "Coping strategies, stress, physical activity and sleep in patients with unexplained chest pain" Dr. Gaston Johansson, examines coping strategies in patients with UCP and examines the relationships between these strategies, negative events, sleep problems, physical activity, stress and pain intensity.
In Other Nursing News:
David A. Thompson, DNSc, RN, and others published an article "Clinical and Economic Outcomes of Post-Operative Hospital Acquired Pneumonia in Patients who Receive Invasive Diagnostic Testing, and Ventilation" in the December issue of the "Journal of Clinical Outcomes Management." The article examines the clinical and economic impact of traditional technologies used in the diagnosis and management of intra-abdominal postoperative surgical patients who develop hospital acquired-pneumonia.
JHUSON doctoral student and clinical instructor Jason Farley MSN, MPH, CRNP, spent Thanksgiving in Namibia, Africa, working with the University of Namibia School of Nursing to complete a needs assessment for the 2007 implementation of a World Health Organization program “Integrated Management of Adolescent and Adult Illnesses.” The program supports a larger role for nursing personnel in developing countries in the care of persons living with HIV/AIDS.
Four JHUSON faculty members and doctoral students presented a variety of posters at the 134th Annual Meeting of the American Public Health Association (APHA) held in Boston, MA last month:
Rosemarie Brager, PhD, CRNP, presented "вЂ˜Guided Care’ for Multi-Morbid Adults," a model that infuses contemporary primary care with state-of-the-art information technology to help address the health care of multi-morbid older Americans in an often fragmented system lacking in quality and efficiency.
Joan Kub, PhD, APRN and SON students Jessica Williams Roberts, Sarah Joyce, Nina Fredland, and Colleen Thornton delivered posters focused on the increasingly recognized public health issue of bullying in the nation’s schools: "Bullying Victimization and Associated Health Outcomes in Elementary School Students," and "No Room for Bullying, an Intervention at a Local School."
Jodi Shaefer,PhD, RN presented “Fetal and Infant Mortality Review (FIMR): Promoting Culturally and Linguistically Competent Health Messages in Multi-Cultural Communities,” and research conducted by Robin Newhouse, PhD, RN, “Developing a Measure of the Impact of Legislation and Organizational Forces on Rural Hospital Nursing.”
The Johns Hopkins University School of Nursing is a global leader in nursing research, education and scholarship and is ranked among the top 10 nursing higher education institutions in the country. The School’s community health program is second in the nation and the nursing research program now holds eighth position among the top nursing schools for securing federal research grants. The School continues to maintain its reputation for excellence and educates nurses who set the highest standards for patient care, exemplify scholarship, and become innovative national and international leaders in the evolution of the nursing profession and the health care system. For more information, visit http://www.son.jhmi.edu/.
Johns Hopkins University School of Nursing
525 North Wolfe St, Rm 525
Baltimore, MD 21205
United States
http://www.son.jhmi.edu/
DURECT Corporation Announces Positive Phase I Study Results With New Product In Development
DURECT Corporation (Nasdaq: DRRX) announced today that it has successfully completed Phase I clinical trials with a new product, DUR-843, which is intended to treat a persistent pain condition. We believe that the persistent pain market remains underserved and that DUR-843 has the potential to provide several advantages over existing pain medications.
"We are pleased to add another product candidate to our pipeline and with the rapid progress and positive results thus far," stated James E. Brown, DVM, President and CEO of DURECT. "As a result of our recent collaboration with Nycomed covering POSIDUR, we are in a stronger financial position and therefore have decided to further develop this product on our own as part of our strategy to become a specialty pharmaceutical company. To that objective, for competitive reasons, DURECT is not disclosing at this time the specific drug delivery technology which underlies DUR-843 as well as the active pharmaceutical agent."
The objectives of the Phase I clinical studies recently completed were to determine the safety and tolerability of DUR-843 in healthy human volunteers as well as evaluate the pharmacokinetics of the active pharmaceutical agent following administration of the product candidate. In these trials, DUR-843 appeared safe and well-tolerated.
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceutical company focused on the development of pharmaceutical systems based on its proprietary drug delivery platform technologies focused on treating chronic and episodic diseases and conditions. The Company currently has a number of late-stage pharmaceutical products in development initially focused on significant unmet medical needs in pain management, with a number of research programs underway in a variety of other therapeutic areas. For more information, please visit http://www.durect.com.
DUR-843 is a drug candidate under development and has not been submitted or approved for commercialization by the US Food and Drug Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding DURECT's product candidate DUR-843, its attributes and commercial potential are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, DURECT's ability to design, enroll, conduct and complete clinical trials, complete the design, development, and manufacturing process development of the product candidate, obtain product and manufacturing approvals from regulatory agencies and manufacture and commercialize the product candidate, as well as marketplace acceptance of the product candidate. Further information regarding these and other risks is included in DURECT's Form 10-Q dated November 3, 2006 under the heading "Risk Factors."
DURECT Corporation
http://www.durect.com
"We are pleased to add another product candidate to our pipeline and with the rapid progress and positive results thus far," stated James E. Brown, DVM, President and CEO of DURECT. "As a result of our recent collaboration with Nycomed covering POSIDUR, we are in a stronger financial position and therefore have decided to further develop this product on our own as part of our strategy to become a specialty pharmaceutical company. To that objective, for competitive reasons, DURECT is not disclosing at this time the specific drug delivery technology which underlies DUR-843 as well as the active pharmaceutical agent."
The objectives of the Phase I clinical studies recently completed were to determine the safety and tolerability of DUR-843 in healthy human volunteers as well as evaluate the pharmacokinetics of the active pharmaceutical agent following administration of the product candidate. In these trials, DUR-843 appeared safe and well-tolerated.
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceutical company focused on the development of pharmaceutical systems based on its proprietary drug delivery platform technologies focused on treating chronic and episodic diseases and conditions. The Company currently has a number of late-stage pharmaceutical products in development initially focused on significant unmet medical needs in pain management, with a number of research programs underway in a variety of other therapeutic areas. For more information, please visit http://www.durect.com.
DUR-843 is a drug candidate under development and has not been submitted or approved for commercialization by the US Food and Drug Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding DURECT's product candidate DUR-843, its attributes and commercial potential are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, DURECT's ability to design, enroll, conduct and complete clinical trials, complete the design, development, and manufacturing process development of the product candidate, obtain product and manufacturing approvals from regulatory agencies and manufacture and commercialize the product candidate, as well as marketplace acceptance of the product candidate. Further information regarding these and other risks is included in DURECT's Form 10-Q dated November 3, 2006 under the heading "Risk Factors."
DURECT Corporation
http://www.durect.com
Pain Therapeutics Initiates Phase III Study With Oxytrex(TM)
Pain Therapeutics, Inc. (Nasdaq: PTIE) today announced the initiation of a Phase III study with Oxytrex, an investigational drug. Oxytrex is a unique oral painkiller for patients who suffer from persistent severe chronic pain. The Company believes Oxytrex offers less physical dependence/withdrawal than oxycodone, an 80-year-old prescription painkiller still widely used today to treat persistent severe chronic pain.
"We remain encouraged by the strong science around Oxytrex published in several top journals, including a recent article in Journal of Neurobiology that further elucidates the unique attributes of ultra-low-dose opioid antagonists," said Remi Barbier, president and chief executive officer.
This study is being referred to as the "Extreme Study" in deference to patients who depend on extremely high daily doses of oxycodone (greater than or equal to 120 mg per day) to treat severe chronic pain. The Company believes this sub-population of patients is prone to physical dependence/withdrawal.
In the second half of 2007, Pain Therapeutics plans to initiate a large study with Oxytrex in a broad patient population.
"Extreme Study" Design
This clinical study is randomized, double-blinded, multi-center and placebo-controlled. The study will enroll approximately 120 patients who have each been taking greater than or equal to 120 mg of oxycodone per patient per day for over a year. Patients who meet this and all other eligibility requirements are randomized to receive twice-daily doses of 100 nanograms (i.e., 0.0001 mg) ultra-low-dose naltrexone or matching placebo for two weeks. At the conclusion of the treatment period, patients check into a clinic and receive an injection of a high-dose opioid antagonist to precipitate withdrawal. During the withdrawal phase of the study, patients are closely monitored and measured for signs and symptoms of physical dependence/withdrawal using the Subjective Opiate Withdrawal Scale. The study's primary endpoint is prospectively defined as physical dependence/withdrawal scores in the treated arm compared to placebo. For ethical and other reasons, the study protocol allows an interim analysis.
About Oxytrex
Pain Therapeutics owns commercial rights to Oxytrex, a unique oral painkiller that preferentially inhibits an excitatory effect of opioid receptors. This excitatory effect is believed to counteract analgesia (pain relief) and cause tolerance. Its inhibition enhances pain relief and minimizes opioid tolerance. The FDA has not yet evaluated the merits, safety or efficacy of Oxytrex.
About Pain Therapeutics, Inc.
Pain Therapeutics is a biopharmaceutical company that develops novel drugs for pain management and oncology. We have three investigational drug candidates in clinical programs. Remoxy(TM) and PTI-202 are proprietary, abuse-resistant forms of opioid drugs. Oxytrex is a novel, next-generation painkiller that potentially offers less physical dependence than currently marketed opioid painkillers. We are also developing a novel radio-labeled monoclonal antibody to treat metastatic melanoma, a rare but deadly form of skin cancer. The FDA has not yet evaluated the merits, safety or efficacy of our drug candidates. For more information, please consult our website: http://www.paintrials.com/.
Note Regarding Forward-Looking Statements:
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). PTI disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to the timing, scope or expected outcome of the Company's clinical development of its drug candidates, the potential benefits of the Company's drug candidates and the size of the potential market for the Company's products. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials), the uncertainty of patent protection for the Company's intellectual property or trade secrets, the Company's ability to obtain additional financing if necessary and unanticipated research and development and other costs. For further information regarding these and other risks related to the Company's business, investors should consult the Company's filings with the Securities and Exchange Commission.
Pain Therapeutics, Inc.
http://www.paintrials.com/
"We remain encouraged by the strong science around Oxytrex published in several top journals, including a recent article in Journal of Neurobiology that further elucidates the unique attributes of ultra-low-dose opioid antagonists," said Remi Barbier, president and chief executive officer.
This study is being referred to as the "Extreme Study" in deference to patients who depend on extremely high daily doses of oxycodone (greater than or equal to 120 mg per day) to treat severe chronic pain. The Company believes this sub-population of patients is prone to physical dependence/withdrawal.
In the second half of 2007, Pain Therapeutics plans to initiate a large study with Oxytrex in a broad patient population.
"Extreme Study" Design
This clinical study is randomized, double-blinded, multi-center and placebo-controlled. The study will enroll approximately 120 patients who have each been taking greater than or equal to 120 mg of oxycodone per patient per day for over a year. Patients who meet this and all other eligibility requirements are randomized to receive twice-daily doses of 100 nanograms (i.e., 0.0001 mg) ultra-low-dose naltrexone or matching placebo for two weeks. At the conclusion of the treatment period, patients check into a clinic and receive an injection of a high-dose opioid antagonist to precipitate withdrawal. During the withdrawal phase of the study, patients are closely monitored and measured for signs and symptoms of physical dependence/withdrawal using the Subjective Opiate Withdrawal Scale. The study's primary endpoint is prospectively defined as physical dependence/withdrawal scores in the treated arm compared to placebo. For ethical and other reasons, the study protocol allows an interim analysis.
About Oxytrex
Pain Therapeutics owns commercial rights to Oxytrex, a unique oral painkiller that preferentially inhibits an excitatory effect of opioid receptors. This excitatory effect is believed to counteract analgesia (pain relief) and cause tolerance. Its inhibition enhances pain relief and minimizes opioid tolerance. The FDA has not yet evaluated the merits, safety or efficacy of Oxytrex.
About Pain Therapeutics, Inc.
Pain Therapeutics is a biopharmaceutical company that develops novel drugs for pain management and oncology. We have three investigational drug candidates in clinical programs. Remoxy(TM) and PTI-202 are proprietary, abuse-resistant forms of opioid drugs. Oxytrex is a novel, next-generation painkiller that potentially offers less physical dependence than currently marketed opioid painkillers. We are also developing a novel radio-labeled monoclonal antibody to treat metastatic melanoma, a rare but deadly form of skin cancer. The FDA has not yet evaluated the merits, safety or efficacy of our drug candidates. For more information, please consult our website: http://www.paintrials.com/.
Note Regarding Forward-Looking Statements:
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). PTI disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to the timing, scope or expected outcome of the Company's clinical development of its drug candidates, the potential benefits of the Company's drug candidates and the size of the potential market for the Company's products. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials), the uncertainty of patent protection for the Company's intellectual property or trade secrets, the Company's ability to obtain additional financing if necessary and unanticipated research and development and other costs. For further information regarding these and other risks related to the Company's business, investors should consult the Company's filings with the Securities and Exchange Commission.
Pain Therapeutics, Inc.
http://www.paintrials.com/
Sea Snail Key To Future Of Pain Relief
Unique research at The University of Queensland could revolutionise the treatment of pain relief - thanks to a humble sea snail.
Dr Jenny Ekberg, a Research Fellow with UQ's School of Biomedical Sciences, has studied a toxin produced by a marine snail found on the Great Barrier Reef, which has the ability to precisely target chronic pain without severe side-effects.
"Chronic pain can be caused by an initial injury that affects the nerves, or conditions such as diabetes and arthritis," Dr Ekberg said.
"The problem with current drugs, such as morphine, is that they sometimes offer only marginal relief and come coupled with lots of problems with tolerance and side-effects.
"Our research show that a natural product, a conotoxin from the marine snail Conus marmoreus, produces pain relief without apparent side-effects in animal models of chronic pain."
The study, done with colleagues Professor David Adams in the School of Biomedical Sciences, Dr Richard Lewis at UQ's Institute for Molecular Bioscience and Professor Mac Christie at the University of Sydney, was recently published in the Proceedings of the National Academy of Sciences.
Dr Ekberg said with approximately one in five Australians will suffer from chronic pain at some point in their life the potential benefit of this research could be enormous.
She said sufferers of chronic pain can have the added problem of being diagnosed with no reason for the pain.
"The patient experiences severe pain because their nerve cells that are responsible for pain transmission are overactive," she said.
"This is primarily due to abnormal activity of voltage-gated sodium channels in the nerve cells.
"Conventional drugs, such as local anaesthetics, block all types of sodium channels, causing severe side-effects.
"Our toxin only blocks a specific channel - the first time a toxin like this has been shown to work - therefore providing pain relief without severe side-effects."
Dr Ekberg said it would be a number of years before such a treatment would be commercially available.
Originally from Sweden, Dr Ekberg came to UQ to complete her Honours in Biomedical Sciences and stayed to complete a PhD, from which this research stemmed, under the supervision of Professor David Adams and Associate Professor Phil Poronnik.
Dr Ekberg said she has since remained at UQ because of a combination of high-class research and a wonderful environment.
For further information please go to:
The University of Queensland, Brisbane Australia
Source:
UQ News Online
Dr Jenny Ekberg, a Research Fellow with UQ's School of Biomedical Sciences, has studied a toxin produced by a marine snail found on the Great Barrier Reef, which has the ability to precisely target chronic pain without severe side-effects.
"Chronic pain can be caused by an initial injury that affects the nerves, or conditions such as diabetes and arthritis," Dr Ekberg said.
"The problem with current drugs, such as morphine, is that they sometimes offer only marginal relief and come coupled with lots of problems with tolerance and side-effects.
"Our research show that a natural product, a conotoxin from the marine snail Conus marmoreus, produces pain relief without apparent side-effects in animal models of chronic pain."
The study, done with colleagues Professor David Adams in the School of Biomedical Sciences, Dr Richard Lewis at UQ's Institute for Molecular Bioscience and Professor Mac Christie at the University of Sydney, was recently published in the Proceedings of the National Academy of Sciences.
Dr Ekberg said with approximately one in five Australians will suffer from chronic pain at some point in their life the potential benefit of this research could be enormous.
She said sufferers of chronic pain can have the added problem of being diagnosed with no reason for the pain.
"The patient experiences severe pain because their nerve cells that are responsible for pain transmission are overactive," she said.
"This is primarily due to abnormal activity of voltage-gated sodium channels in the nerve cells.
"Conventional drugs, such as local anaesthetics, block all types of sodium channels, causing severe side-effects.
"Our toxin only blocks a specific channel - the first time a toxin like this has been shown to work - therefore providing pain relief without severe side-effects."
Dr Ekberg said it would be a number of years before such a treatment would be commercially available.
Originally from Sweden, Dr Ekberg came to UQ to complete her Honours in Biomedical Sciences and stayed to complete a PhD, from which this research stemmed, under the supervision of Professor David Adams and Associate Professor Phil Poronnik.
Dr Ekberg said she has since remained at UQ because of a combination of high-class research and a wonderful environment.
For further information please go to:
The University of Queensland, Brisbane Australia
Source:
UQ News Online
Gene Mutation Which Prevents Carriers From Feeling Pain Discovered By Cambridge Led Team
Researchers have discovered a gene mutation which prevents the otherwise healthy carriers from sensing pain, after studying three related families with a rare genetic disorder in northern Pakistan.
The research, published in the journal Nature, provides insight into the mechanics of pain and could lead to the development of more effective pain treatments.
The carriers of the very rare genetic mutation are unable to perceive any form of pain but have otherwise completely normal sensory functions. The initial case study was a ten-year-old street performer in Pakistan with the genetic mutation. His inability to feel pain enabled him to place knives through his arms and walk on burning coals. (The young boy died before his fourteenth birthday from injures sustained after jumping off a roof.)
The scientists subsequently studied six individuals with the genetic mutation from three related families, all originating from northern Pakistan. The six relatives had not experienced pain at any time in their lives. Detailed neurological examinations revealed that there was no evidence of motor or sensory disease, and that they could perceive a number of sensations (including touch, warm and cold temperature, tickle and pressure).
As pain is a survival mechanism which enables organisms to minimise damage to tissues, they had all sustained a variety of injuries, including injuries to their lips and/or tongue from biting themselves when young.
By studying these individuals, the scientists were able to determine that a mutation in the gene SCN9A causes a loss of function in the voltage-gated sodium channel it encodes (subunit Nav1.7). Sodium channels are proteins which excite neurons, and though the precise function of Nav1.7 is unclear, as part of a sodium channel it would play a role in exciting sensory neurons.
Dr Geoffrey Woods, from the Department of Medical Genetics and the University of Cambridge Institute for Medical Research (CIMR), said, “This paper shows that rare diseases can still be of great importance, because of the insights they give into biological and developmental processes".
Dr John Wood, from University College London, said, “The work of Geoff Woods and his team has provided us with an exciting new target for pain killing drugs - potentially this is as important as the identification of the morphine receptors. It is fascinating that this same gene, when mutated to encode a hyperactive channel, has also been found to contribute to ongoing pain in some heritable human disorders”.
As individuals with mutations in the gene SCN9A are otherwise healthy, the scientists are hopeful that the development of drugs that prevent Nav1.7 from functioning could be used as new and potentially safer pain medications.
###
The collaborative study, spearheaded by academics at the University of Cambridge, included researchers from a number of Pakistani and UK institutions (including University College London) and was funded in part by the Wellcome Trust.
Contact: Genevieve Maul
University of Cambridge
The research, published in the journal Nature, provides insight into the mechanics of pain and could lead to the development of more effective pain treatments.
The carriers of the very rare genetic mutation are unable to perceive any form of pain but have otherwise completely normal sensory functions. The initial case study was a ten-year-old street performer in Pakistan with the genetic mutation. His inability to feel pain enabled him to place knives through his arms and walk on burning coals. (The young boy died before his fourteenth birthday from injures sustained after jumping off a roof.)
The scientists subsequently studied six individuals with the genetic mutation from three related families, all originating from northern Pakistan. The six relatives had not experienced pain at any time in their lives. Detailed neurological examinations revealed that there was no evidence of motor or sensory disease, and that they could perceive a number of sensations (including touch, warm and cold temperature, tickle and pressure).
As pain is a survival mechanism which enables organisms to minimise damage to tissues, they had all sustained a variety of injuries, including injuries to their lips and/or tongue from biting themselves when young.
By studying these individuals, the scientists were able to determine that a mutation in the gene SCN9A causes a loss of function in the voltage-gated sodium channel it encodes (subunit Nav1.7). Sodium channels are proteins which excite neurons, and though the precise function of Nav1.7 is unclear, as part of a sodium channel it would play a role in exciting sensory neurons.
Dr Geoffrey Woods, from the Department of Medical Genetics and the University of Cambridge Institute for Medical Research (CIMR), said, “This paper shows that rare diseases can still be of great importance, because of the insights they give into biological and developmental processes".
Dr John Wood, from University College London, said, “The work of Geoff Woods and his team has provided us with an exciting new target for pain killing drugs - potentially this is as important as the identification of the morphine receptors. It is fascinating that this same gene, when mutated to encode a hyperactive channel, has also been found to contribute to ongoing pain in some heritable human disorders”.
As individuals with mutations in the gene SCN9A are otherwise healthy, the scientists are hopeful that the development of drugs that prevent Nav1.7 from functioning could be used as new and potentially safer pain medications.
###
The collaborative study, spearheaded by academics at the University of Cambridge, included researchers from a number of Pakistani and UK institutions (including University College London) and was funded in part by the Wellcome Trust.
Contact: Genevieve Maul
University of Cambridge
Genetic Mechanism Helps Explain Chronic Pain Disorders
Researchers at the University of North Carolina at Chapel Hill have discovered that commonly occurring variations of a gene trigger a domino effect in chronic pain disorders. The finding might lead to more effective treatments for temporomandibular joint disorder (TMJD) and other chronic pain conditions.
Catechol-O-methyltransferase (COMT), an enzyme that metabolizes neurotransmitters such as epinephrine, norepinephrine and dopamine and that has been implicated in the modulation of persistent pain, as well as cognition and mood, is regulated by a gene, also called COMT. Previous UNC-led research showed that common genetic variants of this gene are associated with increased pain sensitivity and the likelihood of developing TMJD.
Now, the researchers have discovered that specific variants of the COMT gene can dramatically affect the secondary structure of corresponding messenger RNA - which, in turn, leads to alterations in the amount of enzyme crucial for regulating pain processing. The discovery is published in the Dec. 22 issue of Science.
"TMJD is a complex pain condition that is frequently associated with other pain conditions such as fibromyalgia syndrome, chronic headaches and irritable bowel syndrome," said Dr. William Maixner, director of the Center for Neurosensory Disorders in UNC's School of Dentistry and a study co-author.
"This study has identified a new genetic mechanism that influences an individual's susceptibility to develop chronic pain conditions such as TMJD," Maixner said.
The study was conducted to understand the mechanism by which the identified genetic variants influence enzymatic activity and, ultimately, biological functions such as pain transmission. The researchers found that three major variants of COMT show significant differences in how they code for the secondary structure of messenger RNA, or mRNA. The differences lead to dramatic alterations in protein expression, which substantially influences pain sensitivity in humans.
These findings are clinically important because pain conditions resulting from low COMT activity or elevated catecholamine levels are likely to be susceptible to treatment with pharmacological agents that block beta 2- and beta 3-adrenergic receptors, which mediate COMT-dependent pain signaling, or that control mRNA secondary structure.
"Elucidating the genetic mechanisms that mediate pain perception will provide new insights into how chronic pain develops and will ultimately contribute to the identification of unique markers for diagnosing clinical pain conditions, as well as provide novel targets for the development of effective individualized therapeutics for TMJD and related conditions," said Dr. Andrea Nackley Neely, a research assistant professor in the Center for Neurosensory Disorders and the study's lead author.
"These data have broad medical and evolutionary implications regarding the analysis of variants common in the human population," Nackley Neely said. "It is believed that variants leading to altered protein structure have the strongest impact on gene function. However, this study demonstrates that combinations of common genetic variants that influence mRNA secondary structure may have even stronger effects and, thus, represent another key factor responsible for disease onset and progression."
"This study provides additional evidence of a genetic, molecular and physiological basis for pain perception and human pain conditions and should help to remove the stigma associated with conditions such as TMJD and fibromyalgia," said Dr. Luda Diatchenko, an associate professor in the center and the study's chief investigator.
Other researchers were Dr. Inna Tchivileva, a postdoctoral research associate within the Center for Neurosensory Disorders; Kathryn Satterfield, a former research assistant within the center; Dr. Olex Korchynskyi, a former postdoctoral research associate within the UNC-Chapel Hill School of Medicine's Thurston Arthritis Research Center; Dr. Sergei S. Makarov, a former associate professor at the Center for Neurosensory Disorders and the Thurston center and now president and chief executive officer of Attagene Inc.; and Dr. Svetlana A. Shabalina, a staff scientist with the National Center for Biotechnology Information.
Funding was provided by the National Institute of Dental and Craniofacial Research, National Institute of Child Health and Human Development and National Institute of Neurological Disorders and Stroke, all components of the National Institutes of Health. Additional support came from the Intramural Research Program of the National Center for Biotechnology Information.
Other Center for Neurosensory Disorders research initiatives are currently under way that further explore the genetic basis of pain: One seven-study, a $19-million National Institute of Dental and Craniofacial Research-funded agreement involving multiple institutions and based at the center, will follow 3,200 health individuals and 200 who have facial pain. Titled OPPERA (Orofacial Pain: Prospective Evaluation and Risk Assessment), the study is designed to identify both environmental and genetic factors that increase an individual's susceptibility to TMJD and other chronic pain conditions.
University of North Carolina at Chapel Hill
210 Pittsboro St. Campus Box 6210
Chapel Hill, NC 27514
United States
http://www.unc.edu/
Catechol-O-methyltransferase (COMT), an enzyme that metabolizes neurotransmitters such as epinephrine, norepinephrine and dopamine and that has been implicated in the modulation of persistent pain, as well as cognition and mood, is regulated by a gene, also called COMT. Previous UNC-led research showed that common genetic variants of this gene are associated with increased pain sensitivity and the likelihood of developing TMJD.
Now, the researchers have discovered that specific variants of the COMT gene can dramatically affect the secondary structure of corresponding messenger RNA - which, in turn, leads to alterations in the amount of enzyme crucial for regulating pain processing. The discovery is published in the Dec. 22 issue of Science.
"TMJD is a complex pain condition that is frequently associated with other pain conditions such as fibromyalgia syndrome, chronic headaches and irritable bowel syndrome," said Dr. William Maixner, director of the Center for Neurosensory Disorders in UNC's School of Dentistry and a study co-author.
"This study has identified a new genetic mechanism that influences an individual's susceptibility to develop chronic pain conditions such as TMJD," Maixner said.
The study was conducted to understand the mechanism by which the identified genetic variants influence enzymatic activity and, ultimately, biological functions such as pain transmission. The researchers found that three major variants of COMT show significant differences in how they code for the secondary structure of messenger RNA, or mRNA. The differences lead to dramatic alterations in protein expression, which substantially influences pain sensitivity in humans.
These findings are clinically important because pain conditions resulting from low COMT activity or elevated catecholamine levels are likely to be susceptible to treatment with pharmacological agents that block beta 2- and beta 3-adrenergic receptors, which mediate COMT-dependent pain signaling, or that control mRNA secondary structure.
"Elucidating the genetic mechanisms that mediate pain perception will provide new insights into how chronic pain develops and will ultimately contribute to the identification of unique markers for diagnosing clinical pain conditions, as well as provide novel targets for the development of effective individualized therapeutics for TMJD and related conditions," said Dr. Andrea Nackley Neely, a research assistant professor in the Center for Neurosensory Disorders and the study's lead author.
"These data have broad medical and evolutionary implications regarding the analysis of variants common in the human population," Nackley Neely said. "It is believed that variants leading to altered protein structure have the strongest impact on gene function. However, this study demonstrates that combinations of common genetic variants that influence mRNA secondary structure may have even stronger effects and, thus, represent another key factor responsible for disease onset and progression."
"This study provides additional evidence of a genetic, molecular and physiological basis for pain perception and human pain conditions and should help to remove the stigma associated with conditions such as TMJD and fibromyalgia," said Dr. Luda Diatchenko, an associate professor in the center and the study's chief investigator.
Other researchers were Dr. Inna Tchivileva, a postdoctoral research associate within the Center for Neurosensory Disorders; Kathryn Satterfield, a former research assistant within the center; Dr. Olex Korchynskyi, a former postdoctoral research associate within the UNC-Chapel Hill School of Medicine's Thurston Arthritis Research Center; Dr. Sergei S. Makarov, a former associate professor at the Center for Neurosensory Disorders and the Thurston center and now president and chief executive officer of Attagene Inc.; and Dr. Svetlana A. Shabalina, a staff scientist with the National Center for Biotechnology Information.
Funding was provided by the National Institute of Dental and Craniofacial Research, National Institute of Child Health and Human Development and National Institute of Neurological Disorders and Stroke, all components of the National Institutes of Health. Additional support came from the Intramural Research Program of the National Center for Biotechnology Information.
Other Center for Neurosensory Disorders research initiatives are currently under way that further explore the genetic basis of pain: One seven-study, a $19-million National Institute of Dental and Craniofacial Research-funded agreement involving multiple institutions and based at the center, will follow 3,200 health individuals and 200 who have facial pain. Titled OPPERA (Orofacial Pain: Prospective Evaluation and Risk Assessment), the study is designed to identify both environmental and genetic factors that increase an individual's susceptibility to TMJD and other chronic pain conditions.
University of North Carolina at Chapel Hill
210 Pittsboro St. Campus Box 6210
Chapel Hill, NC 27514
United States
http://www.unc.edu/
Psychological Treatments Improve Outcomes For Back Pain Sufferers
Psychological interventions for chronic low back pain are effective, a new review of studies has found. Not only do these approaches improve psychological outcomes such as depression and health-related quality of life, they also reduce patients’ experience of pain.
“Because this analysis was both more inclusive and more conservative than previous reviews, we have the best evidence to date that these interventions are helpful,” said psychologist and review lead author Robert Kerns, Ph.D., of the VA Connecticut Healthcare System.
The review, part of a new article series, appears in the January issue of the journal Health Psychology. Each evidence-based review centers on a specific psychological assessment or treatment conducted in the context of a physical disease process or risk reduction effort.
To evaluate the effects of psychological interventions on pain-related outcomes, Kerns and his team gathered data from 22 randomized trials published between 1982 and 2003. Trials were limited to adults with nonmalignant low back pain that had persisted for at least three months. However, most patients had been living with pain for much longer. The average duration was seven and a half years.
The studies were not limited to any one psychological approach. Included in the review were behavioral and cognitive-behavioral techniques; self-regulatory techniques such as hypnosis, biofeedback, and relaxation; and supportive counseling.
The review reports on 12 pain-related outcomes, including pain intensity, pain interference, depression, health care use, disability and health-related quality of life.
In the broadest analysis, psychological interventions alone or as part of a multidisciplinary approach proved to be superior to waiting lists or standard treatments on the entire range of pain-related outcomes.
When the researchers analyzed specific outcomes, they found that the largest and most consistent effect was a reduction in pain intensity.
This was somewhat surprising, Kerns said, because when psychologists first began developing interventions for chronic pain several decades ago, the goal was not to reduce pain but to help patients live with their pain more successfully.
“However, a growing body of knowledge suggests that these interventions are actually having a primary effect on people’s experience of pain,” he said.
The review found that psychological interventions also yielded improvements in health-related quality of life, work-related disability, interference of pain with daily living and depression.
Not all treatments were equally effective. Cognitive-behavioral and self-regulatory treatments seemed to yield the greatest effects, particularly when compared to waiting list control groups. Multidisciplinary approaches that included a psychological component also stood out on some measures, reducing pain interference and work-related disability when compared to other active treatments.
According to Dennis Turk, Ph.D., a professor of anesthesiology and pain research at the University of Washington in Seattle, patients with chronic pain sometimes fail to recognize the value of psychological treatments because they’ve been set up to expect a cure.
“Even the latest and greatest treatments don’t cure people with chronic pain,” he said. “Psychological interventions are not cures, but they do reduce pain and improve function and they are important components in the treatment of people with chronic pain.”
Turk added that psychological interventions are also cost-effective when compared to other treatments for chronic low back pain a key finding, considering that estimates for treatment-related costs range from $20 billion to $80 billion a year in the United States.
“Surgery, opioids, nerve blocks, spinal cord stimulators, implantable drug delivery systems every one of those particular alternatives is much more expensive and has poorer or at best equal outcomes compared to rehabilitation programs that include psychological components,” said Turk. “The paradox is that, despite data on the effectiveness of psychological interventions, insurers are less willing to pay for them.”
Getting the word out that these treatments are effective and cost-effective is a challenge that psychologists will have to tackle head-on, Kerns said.
“We need to specifically target health care system administrators and third-party payers to try to engage them in a more productive dialogue about the importance of these interventions,” he said. “We continue to have a huge, very costly problem in our society, but we have an intervention that is effective, and we need to do a better job of creating access to these services.”
“Evidence-based Treatment Reviews” is a new series initiated within Health Psychology, an official journal of the American Psychological Association. This series of articles is intended to inform health psychology practice, add to teaching and mentoring resources, and inspire further evidence-based research and questions.
Hoffman BM, et al. Meta-analysis of psychological interventions for chronic low back pain. Health Psychology 26 (1), 2007.
Health Behavior News Service
Center for the Advancement of Health 2000 Florida Ave. NW, Ste 210
Washington, DC 20009
United States
http://www.hbns.org
“Because this analysis was both more inclusive and more conservative than previous reviews, we have the best evidence to date that these interventions are helpful,” said psychologist and review lead author Robert Kerns, Ph.D., of the VA Connecticut Healthcare System.
The review, part of a new article series, appears in the January issue of the journal Health Psychology. Each evidence-based review centers on a specific psychological assessment or treatment conducted in the context of a physical disease process or risk reduction effort.
To evaluate the effects of psychological interventions on pain-related outcomes, Kerns and his team gathered data from 22 randomized trials published between 1982 and 2003. Trials were limited to adults with nonmalignant low back pain that had persisted for at least three months. However, most patients had been living with pain for much longer. The average duration was seven and a half years.
The studies were not limited to any one psychological approach. Included in the review were behavioral and cognitive-behavioral techniques; self-regulatory techniques such as hypnosis, biofeedback, and relaxation; and supportive counseling.
The review reports on 12 pain-related outcomes, including pain intensity, pain interference, depression, health care use, disability and health-related quality of life.
In the broadest analysis, psychological interventions alone or as part of a multidisciplinary approach proved to be superior to waiting lists or standard treatments on the entire range of pain-related outcomes.
When the researchers analyzed specific outcomes, they found that the largest and most consistent effect was a reduction in pain intensity.
This was somewhat surprising, Kerns said, because when psychologists first began developing interventions for chronic pain several decades ago, the goal was not to reduce pain but to help patients live with their pain more successfully.
“However, a growing body of knowledge suggests that these interventions are actually having a primary effect on people’s experience of pain,” he said.
The review found that psychological interventions also yielded improvements in health-related quality of life, work-related disability, interference of pain with daily living and depression.
Not all treatments were equally effective. Cognitive-behavioral and self-regulatory treatments seemed to yield the greatest effects, particularly when compared to waiting list control groups. Multidisciplinary approaches that included a psychological component also stood out on some measures, reducing pain interference and work-related disability when compared to other active treatments.
According to Dennis Turk, Ph.D., a professor of anesthesiology and pain research at the University of Washington in Seattle, patients with chronic pain sometimes fail to recognize the value of psychological treatments because they’ve been set up to expect a cure.
“Even the latest and greatest treatments don’t cure people with chronic pain,” he said. “Psychological interventions are not cures, but they do reduce pain and improve function and they are important components in the treatment of people with chronic pain.”
Turk added that psychological interventions are also cost-effective when compared to other treatments for chronic low back pain a key finding, considering that estimates for treatment-related costs range from $20 billion to $80 billion a year in the United States.
“Surgery, opioids, nerve blocks, spinal cord stimulators, implantable drug delivery systems every one of those particular alternatives is much more expensive and has poorer or at best equal outcomes compared to rehabilitation programs that include psychological components,” said Turk. “The paradox is that, despite data on the effectiveness of psychological interventions, insurers are less willing to pay for them.”
Getting the word out that these treatments are effective and cost-effective is a challenge that psychologists will have to tackle head-on, Kerns said.
“We need to specifically target health care system administrators and third-party payers to try to engage them in a more productive dialogue about the importance of these interventions,” he said. “We continue to have a huge, very costly problem in our society, but we have an intervention that is effective, and we need to do a better job of creating access to these services.”
“Evidence-based Treatment Reviews” is a new series initiated within Health Psychology, an official journal of the American Psychological Association. This series of articles is intended to inform health psychology practice, add to teaching and mentoring resources, and inspire further evidence-based research and questions.
Hoffman BM, et al. Meta-analysis of psychological interventions for chronic low back pain. Health Psychology 26 (1), 2007.
Health Behavior News Service
Center for the Advancement of Health 2000 Florida Ave. NW, Ste 210
Washington, DC 20009
United States
http://www.hbns.org
Premature Babies Probably Feel And Are Aware Of Pain
Although it is wellknown that premature babies react to pain, it has not been known to what extent they are aware of pain and uncomfortable procedures. Therefore premature infants have not always received sufficient analgesia. Now, however, the grounds for this have been seriously undermined by a new doctoral thesis from Karolinska Institutet (KI) in Sweden. New measurement techniques show that even premature babies display all the signs of a conscious experience of pain.
For many years, doctors have assumed that foetuses, premature babies and fully developed new-born babies do not have the cerebral cortical functions required to feel pain. Babies’ reactions to potentially painful stimuli have been explained away as unconscious reflexes, and so doctors have felt it justified to withhold painkillers during surgery and the like so as to avoid adverse reactions.
The doctoral thesis by Italian-Swedish researcher Marco Bartocci now shows that the brains of premature babies are far more developed than previously thought. His studies using infrared spectroscopy, carried out at the Astrid Lindgren Children’s Hospital in Stockholm, Sweden, show that pain signals from a pin prick are processed in the cerebral cortex of premature babies in the same way as in adults. This means that all known pre-conditions for the conscience experience of pain are present, even though this still does not provide any conclusive evidence that they actually undergo a subjective painful experience.
The results of the processing of painful stimuli have been published in the scientific journal Pain and have been cited in a news article in Nature. They are expected to have a major impact on pain-relief management for new-born babies as well as on approaches to child development in general. Public defence of doctoral thesis will be held on December 8. Professor Michael Wweindling from the University of Liverpool, UK is the external examiner.
Thesis: Brain functional near infrared spectroscopy in human infants: cerebral cortical haemodynamics coupled to neuronal activation in response to sensory stimulation , Department of Women and Child Health, Karolinska Institutet.
Karolinska Institutet is one of the leading medical universities in Europe. Through research, education and information, Karolinska Institutet contributes to improving human health. Each year, the Nobel Assembly at Karolinska Institutet awards the Nobel Prize in Physiology or Medicine.
http://diss.kib.ki.se/2006/91-7357-034-6
For many years, doctors have assumed that foetuses, premature babies and fully developed new-born babies do not have the cerebral cortical functions required to feel pain. Babies’ reactions to potentially painful stimuli have been explained away as unconscious reflexes, and so doctors have felt it justified to withhold painkillers during surgery and the like so as to avoid adverse reactions.
The doctoral thesis by Italian-Swedish researcher Marco Bartocci now shows that the brains of premature babies are far more developed than previously thought. His studies using infrared spectroscopy, carried out at the Astrid Lindgren Children’s Hospital in Stockholm, Sweden, show that pain signals from a pin prick are processed in the cerebral cortex of premature babies in the same way as in adults. This means that all known pre-conditions for the conscience experience of pain are present, even though this still does not provide any conclusive evidence that they actually undergo a subjective painful experience.
The results of the processing of painful stimuli have been published in the scientific journal Pain and have been cited in a news article in Nature. They are expected to have a major impact on pain-relief management for new-born babies as well as on approaches to child development in general. Public defence of doctoral thesis will be held on December 8. Professor Michael Wweindling from the University of Liverpool, UK is the external examiner.
Thesis: Brain functional near infrared spectroscopy in human infants: cerebral cortical haemodynamics coupled to neuronal activation in response to sensory stimulation , Department of Women and Child Health, Karolinska Institutet.
Karolinska Institutet is one of the leading medical universities in Europe. Through research, education and information, Karolinska Institutet contributes to improving human health. Each year, the Nobel Assembly at Karolinska Institutet awards the Nobel Prize in Physiology or Medicine.
http://diss.kib.ki.se/2006/91-7357-034-6
A Protein Essential For Touch Sensation - First Evidence For A Touch Receptor Gene In Mammals
The skin is the largest sensory organ in humans. The sensory innervation of the skin allows us to perceive touch and pain. Now, Christiane Wetzel, a researcher in the laboratory of Professor Gary Lewin at the Max DelbrГјck Center for Molecular Medicine (MDC) Berlin-Buch, Germany, and her colleagues have deciphered the function of a molecule necessary for the conversion of mechanical stimuli into neural impulses. They have demonstrated that this molecule, a protein called SLP3, is essential for the detection and discrimination of fine tactile stimuli. This study provides the first evidence for a touch receptor gene in mammals and shows that molecules may in the future prove to be important therapeutic targets for the control of chronic pain. The findings of Christiane Wetzel and Professor Lewin were published in Nature online (DOI: 10.1038/nature05394).
Christiane Wetzel could show that mice lacking SLP3 are unable to distinguish normally between finely structured surfaces. This serious sensory deficit could be traced to the fact that around one third of the mechanoreceptors in the skin of SLP3 mutant mice fail to respond to any mechanical stimulation.
Although the sensation of touch is not usually associated with pain this situation is dramatically altered after injury to nerve. Thus many people with such injuries suffer from chronic pain in which even light brush stimuli can provoke intense pain.
This type of pain, called neuropathic pain, can be modelled in animals and mice lacking SLP3 show virtually no touch-evoked pain when confronted with such a lesion. This data further indicates that by targeting molecules involved in the detection of touch one could achieve a novel way to control neuropathic pain a clinical condition for which few effective treatment options are available.
Touch and pain are detected by sensory neurons which are located in the dorsal root ganglia (DRG) and their “working end” is in the skin attached to the cell body by a long process called the axon. Mechanical stimuli of the skin (brush or pressure) activates the “working end” of the sensory receptor and initiates an electrical signal that is relayed to the spinal cord and brain.
The sensory receptor must then convert a mechanical signal into an electrical signal and this process is called sensory mechanotransduction. It is this process of sensory mechanotransduction, that is very poorly understood in mammals. It is thought that mechanical stimuli are converted into electrical events by specialized ion channels, these channels can be opened when the membrane is physically indented, leading to an increased flow of charged ions into the cell to produce an electrical signal.
In this study the activity of such ion channels was measured in response to extremely small indentation stimuli (nanometer range). It was found that in many sensory neurons SLP3 was required for the function of such mechanosensitive channels.
This study is the very first to show any protein that is directly involved in the detection of touch in mammals. Many genes have been shown to be necessary for mechanosensation in simpler organisms like worms and flies. The SLP3 protein is also very closely related to such a necessary mechanotransduction protein in worms called MEC-2. This study therefore provides the first evidence for a touch receptor gene in mammals and shows that molecules may in the future prove to be important therapeutic targets for the control of chronic pain.
###
*A stomatin-domain protein essential for touch sensation in the mouse
Christiane Wetzel1, Jing Hu1,5, Dieter Riethmacher2,5, Anne Benckendorff1,5, Lena Harder1, Andreas Eilers1, Rabih Moshourab1, Alexey Kozlenkov1, Dominika Labuz3,Ombretta Caspani3, Bettina Erdmann4, Halina Machelska3, Paul A. Heppenstall1,3, and Gary R. Lewin1
1 Growth Factors and Regeneration Group, Max-Delbrück Center for Molecular Medicine and Charité Universitätsmedizin Berlin, Robert-Rössle-Str. 10, Berlin-Buch D-13125 Germany.
2 Zentrum für Molekulare Neurobiologie, Universität Hamburg, Falkenried 94, 20251 Hamburg, Germany.
3 Klinik für Anaesthesiologie und Operative Intensivmedizin, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin,Hindenburgdamm 30, D-12200 Berlin, Germany.
4 Electronmicroscopy, Max-DelbrückCenter for Molecular Medicine, Robert-Rössle-Str. 10, Berlin-Buch D-13125 Germany.
5 These authors made an equal contribution.
Contact:
Barbara Bachtler
Max DelbrГјck Center for Molecular Medicine (MDC) Berlin-Buch
Robert-Rössle-Straße 10; 13125 Berlin; Germany
details here
For further information please go to:
Max DelbrГјck Center for Molecular Medicine
Christiane Wetzel could show that mice lacking SLP3 are unable to distinguish normally between finely structured surfaces. This serious sensory deficit could be traced to the fact that around one third of the mechanoreceptors in the skin of SLP3 mutant mice fail to respond to any mechanical stimulation.
Although the sensation of touch is not usually associated with pain this situation is dramatically altered after injury to nerve. Thus many people with such injuries suffer from chronic pain in which even light brush stimuli can provoke intense pain.
This type of pain, called neuropathic pain, can be modelled in animals and mice lacking SLP3 show virtually no touch-evoked pain when confronted with such a lesion. This data further indicates that by targeting molecules involved in the detection of touch one could achieve a novel way to control neuropathic pain a clinical condition for which few effective treatment options are available.
Touch and pain are detected by sensory neurons which are located in the dorsal root ganglia (DRG) and their “working end” is in the skin attached to the cell body by a long process called the axon. Mechanical stimuli of the skin (brush or pressure) activates the “working end” of the sensory receptor and initiates an electrical signal that is relayed to the spinal cord and brain.
The sensory receptor must then convert a mechanical signal into an electrical signal and this process is called sensory mechanotransduction. It is this process of sensory mechanotransduction, that is very poorly understood in mammals. It is thought that mechanical stimuli are converted into electrical events by specialized ion channels, these channels can be opened when the membrane is physically indented, leading to an increased flow of charged ions into the cell to produce an electrical signal.
In this study the activity of such ion channels was measured in response to extremely small indentation stimuli (nanometer range). It was found that in many sensory neurons SLP3 was required for the function of such mechanosensitive channels.
This study is the very first to show any protein that is directly involved in the detection of touch in mammals. Many genes have been shown to be necessary for mechanosensation in simpler organisms like worms and flies. The SLP3 protein is also very closely related to such a necessary mechanotransduction protein in worms called MEC-2. This study therefore provides the first evidence for a touch receptor gene in mammals and shows that molecules may in the future prove to be important therapeutic targets for the control of chronic pain.
###
*A stomatin-domain protein essential for touch sensation in the mouse
Christiane Wetzel1, Jing Hu1,5, Dieter Riethmacher2,5, Anne Benckendorff1,5, Lena Harder1, Andreas Eilers1, Rabih Moshourab1, Alexey Kozlenkov1, Dominika Labuz3,Ombretta Caspani3, Bettina Erdmann4, Halina Machelska3, Paul A. Heppenstall1,3, and Gary R. Lewin1
1 Growth Factors and Regeneration Group, Max-Delbrück Center for Molecular Medicine and Charité Universitätsmedizin Berlin, Robert-Rössle-Str. 10, Berlin-Buch D-13125 Germany.
2 Zentrum für Molekulare Neurobiologie, Universität Hamburg, Falkenried 94, 20251 Hamburg, Germany.
3 Klinik für Anaesthesiologie und Operative Intensivmedizin, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin,Hindenburgdamm 30, D-12200 Berlin, Germany.
4 Electronmicroscopy, Max-DelbrückCenter for Molecular Medicine, Robert-Rössle-Str. 10, Berlin-Buch D-13125 Germany.
5 These authors made an equal contribution.
Contact:
Barbara Bachtler
Max DelbrГјck Center for Molecular Medicine (MDC) Berlin-Buch
Robert-Rössle-Straße 10; 13125 Berlin; Germany
details here
For further information please go to:
Max DelbrГјck Center for Molecular Medicine
Mutations Can't Go All The Way In Paget Disease
Paget disease is a bone disease that results in enlarged bones and causes bone pain, arthritis, deformities, and fractures. It mostly affects individuals over the age of 40 and has a hereditary component. One gene that is mutated in approximately one third of patients with hereditary Padget disease is p62 (sequestosome 1). However, it has not been clear whether mutations (such as the common p62P392L mutation) in this gene actually cause Paget disease.
In a study appearing online in advance of publication in the January print issue of the Journal of Clinical Investigation, Noriyoshi Kurihara and colleagues from the VA Pittsburgh Healthcare System show that expression of the p62P392L mutation causes abnormal development of human bone cells in vitro and mouse bone cells in vivo but does not cause a Padget-like disease in mice. Specifically, expression of p62P392L in the precursors of human bone cells known as osteoclasts (the cells that destroy bone) caused them to be more responsive to factors that drive osteoclast development. Similarly, expression of p62P392L in osteoclast-lineage cells in mice resulted in increased numbers of osteoclasts. Although increased numbers of osteoclasts is a feature of Paget disease, it is not the full range of characteristics. This study therefore suggests that although mutations in p62 predispose an individual to developing Paget disease, other factors are required for the full development of Paget disease.
TITLE: Mutation of the sequestosome 1 (p62) gene increases osteoclastogenesis but does not induce Paget disease
###
JCI table of contents: Dec. 21, 2006
AUTHOR CONTACT:
Noriyoshi Kurihara
VA Pittsburgh Healthcare System and University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Contact: Karen Honey
Journal of Clinical Investigation
In a study appearing online in advance of publication in the January print issue of the Journal of Clinical Investigation, Noriyoshi Kurihara and colleagues from the VA Pittsburgh Healthcare System show that expression of the p62P392L mutation causes abnormal development of human bone cells in vitro and mouse bone cells in vivo but does not cause a Padget-like disease in mice. Specifically, expression of p62P392L in the precursors of human bone cells known as osteoclasts (the cells that destroy bone) caused them to be more responsive to factors that drive osteoclast development. Similarly, expression of p62P392L in osteoclast-lineage cells in mice resulted in increased numbers of osteoclasts. Although increased numbers of osteoclasts is a feature of Paget disease, it is not the full range of characteristics. This study therefore suggests that although mutations in p62 predispose an individual to developing Paget disease, other factors are required for the full development of Paget disease.
TITLE: Mutation of the sequestosome 1 (p62) gene increases osteoclastogenesis but does not induce Paget disease
###
JCI table of contents: Dec. 21, 2006
AUTHOR CONTACT:
Noriyoshi Kurihara
VA Pittsburgh Healthcare System and University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Contact: Karen Honey
Journal of Clinical Investigation
Pain Relief Effectiveness Down To Mind-Set?
Research by the Human Pain Research Group at The University of Manchester suggests that people's responses to placebo or "dummy" pain relief varies according to their way of thinking.
40 pain-free volunteers took part in an experiment funded by the Arthritis Research Campaign using an artificial pain stimulus, and were led to expect reduced pain after the application of a cream which was actually a placebo.
Lead researcher Alison Watson said: "Any medical treatment involves a placebo element; the psychological suggestion that it is going to work. So we theorised that a proportion of any treatment's effectiveness would relate to how much we wanted it to work, believed in it or trusted the person administering it.
"Doctors and nurses can transmit a lot of information about a treatment and its effectiveness through their words and gestures. We know that when people visit their preferred GP the treatment or advice they receive will be more effective than that given by a GP they prefer not to see. Similarly, red pills have been shown to be more effective than green ones; so we wanted to test whether all this was due to expectations of successful treatment and trust in the person giving it."
24 of the volunteers initially received a moderately painful heat stimulus to both arms. The placebo cream was then applied to the skin, but they were led to believe that the cream on one of their arms may be a local anaesthetic.
After the application of the cream, the intensity of the heat stimulus was turned down on one arm without informing the volunteer. Subsequently the intensity was returned to its previous level, but - in contrast to the 16 people in the control group - 67% of the treatment group continued to perceive the heat as less painful.
Alison said: "The expectation of pain relief leads to a release of endorphins, the brain's natural pain killers, which is likely to contribute to a sensation of reward and well-being.
"Interestingly, there was an exact split in the range of responses to the placebo; a third of people reporting a reduction in the pain intensity in the "treated" arm only, another third in both arms and the remainder's intensity-ratings not being influenced by the application of the cream. The different responses can be related to the different levels of pain relief the volunteers expected, which may have allowed their individual suggestibility to influence their assessment of the pain experience.
"Our findings suggest that different individuals may have different styles of placebo response, which is likely to affect how they respond to real treatments too. Understanding these differences could better inform the way doctors and nurses provide treatments in the future.
"It could also facilitate more effective clinical trial design, which could substantially reduce the costs of developing new pain killers for patients with conditions like cancer and arthritis.
"A further, exciting possibility is that we could develop talking and drug-based therapies to enhance people's response to placebos. The experimental methods we're using will allow us to test out such possibilities as a method of treating pain."
###
A copy of the full paper, published in the Elsevier journal Pain, is available upon request.
For further information
Mikaela Sitford:
Jo Nightingale:
The University of Manchester (http://www.manchester.ac.uk/) is the largest single-site higher education institution in the country, with 24 academic schools, over 5200 academic and research staff and around 36 000 students. It was awarded University of the Year by the Times Higher Educational Supplement in 2005 and The Sunday Times in 2006, and receives more undergraduate applications than any other UK university.
Its Faculty of Medical & Human Sciences (www.mhs.manchester.ac.uk) is one of the largest faculties of clinical and health sciences in Europe, with a research income of around ВЈ51 million (almost a third of the University's total research income). The School of Medicine http://www.mhs.manchester.ac.uk/) is the largest of its five Schools, encompasses five teaching hospitals and is closely linked to general hospitals and community practices across the North West of England.
The Arthritis Research Campaign (arc), founded in 1936, raises funds to promote medical research into the cause, treatment and cure of arthritic conditions: to educate medical students, doctors and allied healthcare professionals about arthritis and to provide information to people affected by arthritis and to the general public. arc is the only major medical research charity in the UK investigating arthritis in all its forms. Millions of pounds are provided every year for grants funding research, education and training.
Contact: Mikaela Sitford
University of Manchester
40 pain-free volunteers took part in an experiment funded by the Arthritis Research Campaign using an artificial pain stimulus, and were led to expect reduced pain after the application of a cream which was actually a placebo.
Lead researcher Alison Watson said: "Any medical treatment involves a placebo element; the psychological suggestion that it is going to work. So we theorised that a proportion of any treatment's effectiveness would relate to how much we wanted it to work, believed in it or trusted the person administering it.
"Doctors and nurses can transmit a lot of information about a treatment and its effectiveness through their words and gestures. We know that when people visit their preferred GP the treatment or advice they receive will be more effective than that given by a GP they prefer not to see. Similarly, red pills have been shown to be more effective than green ones; so we wanted to test whether all this was due to expectations of successful treatment and trust in the person giving it."
24 of the volunteers initially received a moderately painful heat stimulus to both arms. The placebo cream was then applied to the skin, but they were led to believe that the cream on one of their arms may be a local anaesthetic.
After the application of the cream, the intensity of the heat stimulus was turned down on one arm without informing the volunteer. Subsequently the intensity was returned to its previous level, but - in contrast to the 16 people in the control group - 67% of the treatment group continued to perceive the heat as less painful.
Alison said: "The expectation of pain relief leads to a release of endorphins, the brain's natural pain killers, which is likely to contribute to a sensation of reward and well-being.
"Interestingly, there was an exact split in the range of responses to the placebo; a third of people reporting a reduction in the pain intensity in the "treated" arm only, another third in both arms and the remainder's intensity-ratings not being influenced by the application of the cream. The different responses can be related to the different levels of pain relief the volunteers expected, which may have allowed their individual suggestibility to influence their assessment of the pain experience.
"Our findings suggest that different individuals may have different styles of placebo response, which is likely to affect how they respond to real treatments too. Understanding these differences could better inform the way doctors and nurses provide treatments in the future.
"It could also facilitate more effective clinical trial design, which could substantially reduce the costs of developing new pain killers for patients with conditions like cancer and arthritis.
"A further, exciting possibility is that we could develop talking and drug-based therapies to enhance people's response to placebos. The experimental methods we're using will allow us to test out such possibilities as a method of treating pain."
###
A copy of the full paper, published in the Elsevier journal Pain, is available upon request.
For further information
Mikaela Sitford:
Jo Nightingale:
The University of Manchester (http://www.manchester.ac.uk/) is the largest single-site higher education institution in the country, with 24 academic schools, over 5200 academic and research staff and around 36 000 students. It was awarded University of the Year by the Times Higher Educational Supplement in 2005 and The Sunday Times in 2006, and receives more undergraduate applications than any other UK university.
Its Faculty of Medical & Human Sciences (www.mhs.manchester.ac.uk) is one of the largest faculties of clinical and health sciences in Europe, with a research income of around ВЈ51 million (almost a third of the University's total research income). The School of Medicine http://www.mhs.manchester.ac.uk/) is the largest of its five Schools, encompasses five teaching hospitals and is closely linked to general hospitals and community practices across the North West of England.
The Arthritis Research Campaign (arc), founded in 1936, raises funds to promote medical research into the cause, treatment and cure of arthritic conditions: to educate medical students, doctors and allied healthcare professionals about arthritis and to provide information to people affected by arthritis and to the general public. arc is the only major medical research charity in the UK investigating arthritis in all its forms. Millions of pounds are provided every year for grants funding research, education and training.
Contact: Mikaela Sitford
University of Manchester
Physical Therapists Can Help Relieve Pain
In light of proposed sterner warning labels for acetaminophen, aspirin, and ibuprofen by federal health officials, patients may wish to consider the benefits of physical therapist intervention for pain relief from certain conditions, according to the American Physical Therapy Association (APTA).
"Many people are looking for alternatives to the sole use of medication to deal with painful conditions," said APTA President R Scott Ward, PT, PhD. "Pain medication may help you get through periods of severe pain, but it won't always help you eliminate the underlying cause of some kinds of pain. For many individuals, it is the underlying causes such as poor posture and alignment, weak and/or inflexible muscles, or tight joint structures that actually exacerbate the painful condition," Ward explained. "A physical therapist will perform a complete musculoskeletal examination and design an individualized treatment program to reduce pain and improve function."
There are many types of pain and inflammation that can be reduced by physical therapist intervention. For example, chronic pain in the back, shoulder, or knee, or pain associated with certain degenerative diseases such as osteoarthritis, can be reduced with the appropriate combination of medication and exercise. "The physical therapist, in collaboration with the patient and the patient's physician, can help the patient manage his or her health over the long term," explained Ward.
For pain of a "mechanical" origin such as back, shoulder, or knee pain, physical therapist intervention may include therapeutic exercise, manual therapy, and functional training. "The goal of the physical therapist is to reduce pain, improve the ability to perform daily activities, and help the patient return to doing the things he or she likes to do," said Ward. "It is also true that patients may unknowingly contribute to their own pain, such as by exercising improperly or with poor posture, and physical therapists can identify and help to correct those behaviors." Ward added, "Through the use of home programs designed to fit the patient's needs, the physical therapist can efficiently progress the patient's rehabilitation and teach the patient how to prevent a recurrence of the original condition."
For osteoarthritis, a degenerative disease of the cartilage and bone, physical therapist intervention may include exercises for strength, flexibility, range of motion, and the use of devices designed to rest or support the joint, such as orthotics or splints.
Physical therapists, who treat nearly 1 million people every day, work with individuals to prevent the loss of mobility before it occurs by developing fitness- and wellness-oriented programs for healthier and more active lifestyles. Many insurance policies also cover post-rehabilitation gym programs. "Most people who desire a fitness plan are not athletes," Ward explained. "They are 'ordinary people' who exercise lightly to moderately. Many have a prior health condition, such as chronic low back pain, that can benefit greatly from physical therapist management focused on increasing muscle strength and endurance, restoring and improving range of motion in joints, increasing cardiovascular endurance, and decreasing muscle and joint pain." The physical therapist individualizes exercise programs based on functional limitations as a result of injury or illness.
For more information on physical therapy or to find a physical therapist near you, please visit http://www.apta.org/consumer.
The American Physical Therapy Association (http://www.apta.org) is a national professional organization representing more than 70,000 physical therapists, physical therapist assistants, and students. Its goal is to foster advancements in physical therapy practice, research, and education.
American Physical Therapy Association
http://www.apta.org
"Many people are looking for alternatives to the sole use of medication to deal with painful conditions," said APTA President R Scott Ward, PT, PhD. "Pain medication may help you get through periods of severe pain, but it won't always help you eliminate the underlying cause of some kinds of pain. For many individuals, it is the underlying causes such as poor posture and alignment, weak and/or inflexible muscles, or tight joint structures that actually exacerbate the painful condition," Ward explained. "A physical therapist will perform a complete musculoskeletal examination and design an individualized treatment program to reduce pain and improve function."
There are many types of pain and inflammation that can be reduced by physical therapist intervention. For example, chronic pain in the back, shoulder, or knee, or pain associated with certain degenerative diseases such as osteoarthritis, can be reduced with the appropriate combination of medication and exercise. "The physical therapist, in collaboration with the patient and the patient's physician, can help the patient manage his or her health over the long term," explained Ward.
For pain of a "mechanical" origin such as back, shoulder, or knee pain, physical therapist intervention may include therapeutic exercise, manual therapy, and functional training. "The goal of the physical therapist is to reduce pain, improve the ability to perform daily activities, and help the patient return to doing the things he or she likes to do," said Ward. "It is also true that patients may unknowingly contribute to their own pain, such as by exercising improperly or with poor posture, and physical therapists can identify and help to correct those behaviors." Ward added, "Through the use of home programs designed to fit the patient's needs, the physical therapist can efficiently progress the patient's rehabilitation and teach the patient how to prevent a recurrence of the original condition."
For osteoarthritis, a degenerative disease of the cartilage and bone, physical therapist intervention may include exercises for strength, flexibility, range of motion, and the use of devices designed to rest or support the joint, such as orthotics or splints.
Physical therapists, who treat nearly 1 million people every day, work with individuals to prevent the loss of mobility before it occurs by developing fitness- and wellness-oriented programs for healthier and more active lifestyles. Many insurance policies also cover post-rehabilitation gym programs. "Most people who desire a fitness plan are not athletes," Ward explained. "They are 'ordinary people' who exercise lightly to moderately. Many have a prior health condition, such as chronic low back pain, that can benefit greatly from physical therapist management focused on increasing muscle strength and endurance, restoring and improving range of motion in joints, increasing cardiovascular endurance, and decreasing muscle and joint pain." The physical therapist individualizes exercise programs based on functional limitations as a result of injury or illness.
For more information on physical therapy or to find a physical therapist near you, please visit http://www.apta.org/consumer.
The American Physical Therapy Association (http://www.apta.org) is a national professional organization representing more than 70,000 physical therapists, physical therapist assistants, and students. Its goal is to foster advancements in physical therapy practice, research, and education.
American Physical Therapy Association
http://www.apta.org
Is Workers' Comp Fair? Research Finds No Link Between Cash Settlements, Future Impairment
People who receive higher disability ratings for work-related back injuries don't necessarily fare worse over the long term than those who get lower ratings, a Saint Louis University study finds.
The study, which reinforced previous research showing blacks receive less treatment for their back pain than whites, was published online this month in the Journal of Pain. The new research is among the first to examine the relationship between Workers' Compensation settlements for back pain and long-term functional outcomes.
"A disability rating is supposed to reflect the amount of impairment a person has at the time that a case is closed. The presumption is that levels of impairment are stable and related to day-to-day levels of function. I was shocked that the associations between disability rating and subsequent levels of function weren't stronger," said Raymond Tait, Ph.D., professor of psychiatry at Saint Louis University School of Medicine.
Disability ratings also differed between African-Americans and Caucasians. According to Tait, those differences probably reflected differences in treatment: whites were four times more likely to have surgery than blacks. Thos who had surgery received larger settlements for their injuries, Tait said.
"While surgery inflated disability ratings, there appeared not relationship between surgery outcomes and how a person did thereafter," he said.
Tait and colleague John Chibnall, Ph.D., also a professor of psychiatry at Saint Lois University, looked at about 1,500 Missouri workers - 580 African-Americans and 892 Caucasians - whose Workers' Compensation claims for lower back pain were settled between Jan. 1, 2001 and June 1, 2002.
Researchers interviewed the employees 21 months after their settlements about how they were doing. They asked questions about pain intensity, general physical and mental health and whether they currently were working.
Tait and Chibnall said that their findings "raise questions about both the validity and the fairness of the current disability determination program. Disability settlements are designed to give people money toward a fresh start. Those settlements do not appear to reflect the residual levels of disability that people actually experience."
###
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious disease.
Contact: Nancy Solomon
Saint Louis University
The study, which reinforced previous research showing blacks receive less treatment for their back pain than whites, was published online this month in the Journal of Pain. The new research is among the first to examine the relationship between Workers' Compensation settlements for back pain and long-term functional outcomes.
"A disability rating is supposed to reflect the amount of impairment a person has at the time that a case is closed. The presumption is that levels of impairment are stable and related to day-to-day levels of function. I was shocked that the associations between disability rating and subsequent levels of function weren't stronger," said Raymond Tait, Ph.D., professor of psychiatry at Saint Louis University School of Medicine.
Disability ratings also differed between African-Americans and Caucasians. According to Tait, those differences probably reflected differences in treatment: whites were four times more likely to have surgery than blacks. Thos who had surgery received larger settlements for their injuries, Tait said.
"While surgery inflated disability ratings, there appeared not relationship between surgery outcomes and how a person did thereafter," he said.
Tait and colleague John Chibnall, Ph.D., also a professor of psychiatry at Saint Lois University, looked at about 1,500 Missouri workers - 580 African-Americans and 892 Caucasians - whose Workers' Compensation claims for lower back pain were settled between Jan. 1, 2001 and June 1, 2002.
Researchers interviewed the employees 21 months after their settlements about how they were doing. They asked questions about pain intensity, general physical and mental health and whether they currently were working.
Tait and Chibnall said that their findings "raise questions about both the validity and the fairness of the current disability determination program. Disability settlements are designed to give people money toward a fresh start. Those settlements do not appear to reflect the residual levels of disability that people actually experience."
###
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious disease.
Contact: Nancy Solomon
Saint Louis University
First Look At Sickle Cell Disease Hospitalizations In 10 Years
The first federal analysis in a decade of sickle cell disease hospitalizations shows that admissions of adults remained stable from 1997 to 2004. In 2004, roughly 83,000 hospital stays were for adults and 30,000 were for children. Of the latter, 2,000 stays were for infants, according to the latest News and Numbers issued by the Agency for Healthcare Research and Quality.
Sickle cell disease, an inherited blood disease mostly affecting African Americans, causes red blood cells to lose their shape, block circulation and cause organ damage. The illness has no common cure and patients with periodic pain are often treated with pain medications.
The study found:
-- Patients spent about 5 days in the hospital, which cost facilities an average of $6,223 per stay. Total hospital costs were nearly $500 million overall in 2004
-- Medicaid paid for 65 percent of the stays of patients hospitalized primarily for sickle cell disease, Medicare paid 13 percent, private insurers were responsible for 15 percent, and 4 percent were uninsured.
-- The number of persons with sickle cell disease who died while hospitalized in 2004 was relatively low -- 699 adults and 47 children. In-hospital deaths for children remained low and constant from 1994 to 2004.
This News and Numbers is based on data in Sickle Cell Disease Patients in U.S. Hospitals, 2004, HCUP Statistical Brief # 21.В The report uses statistics from the Nationwide Inpatient Sample, a database of hospital inpatient stays that is nationally representative of all short-term, non-federal hospitals. The data are drawn from hospitals that comprise 90 percent of all discharges in the United States and include all patients, regardless of insurance type as well as the uninsured.
http://www.ahrq.gov
Sickle cell disease, an inherited blood disease mostly affecting African Americans, causes red blood cells to lose their shape, block circulation and cause organ damage. The illness has no common cure and patients with periodic pain are often treated with pain medications.
The study found:
-- Patients spent about 5 days in the hospital, which cost facilities an average of $6,223 per stay. Total hospital costs were nearly $500 million overall in 2004
-- Medicaid paid for 65 percent of the stays of patients hospitalized primarily for sickle cell disease, Medicare paid 13 percent, private insurers were responsible for 15 percent, and 4 percent were uninsured.
-- The number of persons with sickle cell disease who died while hospitalized in 2004 was relatively low -- 699 adults and 47 children. In-hospital deaths for children remained low and constant from 1994 to 2004.
This News and Numbers is based on data in Sickle Cell Disease Patients in U.S. Hospitals, 2004, HCUP Statistical Brief # 21.В The report uses statistics from the Nationwide Inpatient Sample, a database of hospital inpatient stays that is nationally representative of all short-term, non-federal hospitals. The data are drawn from hospitals that comprise 90 percent of all discharges in the United States and include all patients, regardless of insurance type as well as the uninsured.
http://www.ahrq.gov
Headaches Form Over A Possible New Form Of Aspirin
New scientific insights into the packaging of molecules in solids may tempt jokesters to add a second line to that old medical axiom, "Take two aspirin and call me in the morning." Insiders familiar with an unfolding controversy about aspirin -- more than 100 billion tablets of which are produced worldwide each year -- might quip, "Well, doctor, should I take Form I or Form II?"
An article schedule
d for the Jan.1 issue of Chemical & Engineering News, the ACS' weekly newsmagazine, discusses the controversy that has arisen since 2006, when scientists isolated, described and filed a patent for a putative new form of aspirin. Written by C&EN senior editor Ivan Amato, the article describes subtle differences in the crystal, or internal, structures of familiar acetylsalicylic acid and the newly described Form II of aspirin.
The article explains that the discovery of Form II may not have any practical implications for people who take aspirin. However, uncertainties about Form II do showcase surprising knowledge gaps in organic chemists' understanding of the solid state of matter, Amato writes. Those gaps are apparent at a time when pharmaceutical companies are recognizing that minuscule differences in the crystal structures of drugs can have big influences on how drugs work in patients.
ARTICLE #5
"Aspirin's Dose of Structural Insight: A recently identified crystal packing of aspirin is reminding chemists that discoveries lurk in the most familiar places"
FOR FULL TEXT, CONTACT:
Michael Bernstein
ACS News Service
###
ACS News Service Weekly PressPac -- Dec. 20, 2006
The American Chemical Society -- the world's largest scientific society -- is a nonprofit organization chartered by the U.S. Congress and a global leader in providing access to chemistry-related research through its multiple databases, peer-reviewed journals and scientific conferences. Its main offices are in Washington, D.C., and Columbus, Ohio.
Contact: Michael Woods
American Chemical Society
An article schedule
d for the Jan.1 issue of Chemical & Engineering News, the ACS' weekly newsmagazine, discusses the controversy that has arisen since 2006, when scientists isolated, described and filed a patent for a putative new form of aspirin. Written by C&EN senior editor Ivan Amato, the article describes subtle differences in the crystal, or internal, structures of familiar acetylsalicylic acid and the newly described Form II of aspirin.
The article explains that the discovery of Form II may not have any practical implications for people who take aspirin. However, uncertainties about Form II do showcase surprising knowledge gaps in organic chemists' understanding of the solid state of matter, Amato writes. Those gaps are apparent at a time when pharmaceutical companies are recognizing that minuscule differences in the crystal structures of drugs can have big influences on how drugs work in patients.
ARTICLE #5
"Aspirin's Dose of Structural Insight: A recently identified crystal packing of aspirin is reminding chemists that discoveries lurk in the most familiar places"
FOR FULL TEXT, CONTACT:
Michael Bernstein
ACS News Service
###
ACS News Service Weekly PressPac -- Dec. 20, 2006
The American Chemical Society -- the world's largest scientific society -- is a nonprofit organization chartered by the U.S. Congress and a global leader in providing access to chemistry-related research through its multiple databases, peer-reviewed journals and scientific conferences. Its main offices are in Washington, D.C., and Columbus, Ohio.
Contact: Michael Woods
American Chemical Society
Patients With PTSD Experience Less Pain Sensitivity -- May Be Related To Altered Processing
Patients with posttraumatic stress disorder show reduced pain sensitivity, a pattern that may be related to altered pain processing in the brain, according to a report in the January issue of the Archives of General Psychiatry, one of the JAMA/Archives journals.
Posttraumatic stress disorder (PTSD) is an anxiety disorder that may occur in individuals exposed to a traumatic event. It is characterized by chronic arousal, re-experience of the event, and avoidance of stimuli related to the event, according to background information in the article. To the authors' knowledge, no functional imaging study has explored whether patients with PTSD experience and process pain in a different way than control subjects.
Elbert Geuze, Ph.D., of Central Military Hospital and the Rudolph Magnus Institute of Neuroscience, Utrecht, the Netherlands, and colleagues conducted a study to examine neural correlates of pain processing in patients with PTSD. Twelve male Dutch veterans with PTSD and 12 male veterans without PTSD were recruited and matched for age, region of deployment and year of deployment. The experimental procedure consisted of psychophysical assessment and neuroimaging with functional magnetic resonance imaging (fMRI)--the use of magnetic resonance imaging to learn which regions of the brain are active in a specific function. During fMRI, the patients rated the pain they experienced from fixed and variable temperatures applied to their hands.
"Patients with PTSD rated temperatures in the fixed-temperature assessment as less painful compared with controls," the authors report.
"Before fMRI, patients with PTSD already showed a significant reduction in pain sensitivity," the authors write. "During imaging, patients with PTSD rated a fixed temperature as significantly less painful than control veterans." Patients with PTSD showed altered pain processing in brain areas associated with mood and cognitive pain processing.
"These data provide evidence for reduced pain sensitivity in PTSD. The witnessed neural activation pattern is proposed to be related to altered pain processing in patients with PTSD," the authors conclude.
###
(Arch Gen Psychiatry. 2007;64:76-85.)
This study was supported by the Dutch Ministry of Defense. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Contact: Elbert Geuze, Ph.D.
JAMA and Archives Journals
Posttraumatic stress disorder (PTSD) is an anxiety disorder that may occur in individuals exposed to a traumatic event. It is characterized by chronic arousal, re-experience of the event, and avoidance of stimuli related to the event, according to background information in the article. To the authors' knowledge, no functional imaging study has explored whether patients with PTSD experience and process pain in a different way than control subjects.
Elbert Geuze, Ph.D., of Central Military Hospital and the Rudolph Magnus Institute of Neuroscience, Utrecht, the Netherlands, and colleagues conducted a study to examine neural correlates of pain processing in patients with PTSD. Twelve male Dutch veterans with PTSD and 12 male veterans without PTSD were recruited and matched for age, region of deployment and year of deployment. The experimental procedure consisted of psychophysical assessment and neuroimaging with functional magnetic resonance imaging (fMRI)--the use of magnetic resonance imaging to learn which regions of the brain are active in a specific function. During fMRI, the patients rated the pain they experienced from fixed and variable temperatures applied to their hands.
"Patients with PTSD rated temperatures in the fixed-temperature assessment as less painful compared with controls," the authors report.
"Before fMRI, patients with PTSD already showed a significant reduction in pain sensitivity," the authors write. "During imaging, patients with PTSD rated a fixed temperature as significantly less painful than control veterans." Patients with PTSD showed altered pain processing in brain areas associated with mood and cognitive pain processing.
"These data provide evidence for reduced pain sensitivity in PTSD. The witnessed neural activation pattern is proposed to be related to altered pain processing in patients with PTSD," the authors conclude.
###
(Arch Gen Psychiatry. 2007;64:76-85.)
This study was supported by the Dutch Ministry of Defense. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Contact: Elbert Geuze, Ph.D.
JAMA and Archives Journals
Mayo Clinic Successfuly Separates Conjoined Baby Twins Abby And Maddy
Conjoined 5-month old twins, Abygail and Madysen Fitterer from North Dakota, have been successfully separated by surgeons at Minnesota's Mayo Clinic. Doctors say they are doing well.
The surgery took 6 hours and involved a large team of 40 surgeons and nursing staff, led by Christopher Moir, the lead surgeon.
Abygail and Madysen's parents, Stacy and Suzy Fitterer, of Bismarck, North Dakota, in a webcast news conference released earlier today, expressed their joy at the successful outcome and thanked the doctors and nurses and all their supporters. Also present was their two and half year old son, Nicholas.
Dr. Moir said that it had been a very emotional day, but that the operation had been "flawless" and "went exactly as we had hoped, and exactly as we had planned. Abby and Maddy are still together in our hearts, in our minds and in our spirits, and right now they are up in the ICU together working their hardest after a long but very successful operation".
Dr. Moir described the surgical challenges of the operation with the aid of life-sized models of the babies' ribcages and chest cavities. There were two sets of models: one set for before the separation and another set for afterwards. The models had been created by the Mayo clinic's department of engineering and their team of medical illustrators.
Using the life-sized models the surgical team was able to plan the surgery and the reconstruction in great detail in advance.
Much of the operation involved separating the chest and abdominal walls that were conjoined, and then the separation of the major organs. The hearts had to be repositioned and the chest walls reconstructed. Also, the babies shared one liver, but this could be divided because there were separate drainage systems.
As the baby girls were joined at the chest, their hospitalization had to start nearly 100 days earlier, in June 2006, when they were just 8 weeks old. This was when they had their first operation, it lasted 4 hours and involved placing chest expanders under the skin on their shared chest wall.
Over the following 3 months, the chest expanders caused the skin and muscle around the chest wall to stretch and regrow. If the skin and muscle is not stretched it is not possible to close the hole left after separation.
The operation to separate the twins started at 09.50 AM (CST), and they were placed on separate operating tables, ready for chest reconstruction at 12.27. The Mayo Clinic video shows the surgical team applauding as the girls are placed on the tables.
The Mayo Clinic has performed four previous separations of conjoined twins. According to their press release, conjoined twins can occur in one in 50,000 pregnancies, but they account for only 1 in 250,000 live births.
Abygail and Madysen Fitterer's webpage (Caringbridge).
Written by: Catharine Paddock
Writer: Medical News Today
DURECT Starts Phase II Dosing For TRANSDUR(TM)-Bupivacaine (DUR-843)
DURECT Corporation (Nasdaq: DRRX) today announced that we have started Phase II dosing in the U.S. under an FDA-accepted Investigational New Drug (IND) application for TRANSDUR(TM)-Bupivacaine (DUR-843), a transdermal pain patch for patients suffering from Post-Herpetic Neuralgia (post-shingles pain or PHN).
DURECT's Phase I trial for TRANSDUR-Bupivacaine, initially reported on December 11, 2006, demonstrated good safety, tolerability and drug release for up to 3 days. TRANSDUR-Bupivacaine is intended to provide up to 3 days of pain relief for patients suffering from PHN, as compared to a wearing time limited to 12 hours with currently available patches.
"The initiation of the Phase II program for TRANSDUR-Bupivacaine is an important milestone for us," said James E. Brown, DURECT's President and CEO. "Based on our TRANSDUR technology, we believe that the product profile of TRANSDUR-Bupivacaine represents an improvement over existing pain control products for patients suffering from PHN."
DURECT's Phase II program for TRANSDUR-Bupivacaine has begun with a randomized, multi-center, double-blind, placebo controlled, two-way crossover trial in approximately 50 patients with PHN to assess safety as well as the magnitude, duration and characteristics of analgesic activity of TRANSDUR- Bupivacaine.
Bupivacaine, the active agent in TRANSDUR-Bupivacaine, is a potent, FDA- approved long-acting local anesthetic used in regional anesthesia including infiltration, nerve block, epidural and intrathecal anesthesia. Bupivacaine is a more potent sodium channel blocker and has a longer duration of action than lidocaine, the active ingredient for Lidoderm(R), the market leader for post- herpetic neuralgia pain management.
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceutical company focused on the development of pharmaceutical systems based on its proprietary drug delivery platform technologies focused on treating chronic and episodic diseases and conditions. The Company currently has a number of late-stage pharmaceutical products in development initially focused on significant unmet medical needs in pain management, with a number of research programs underway in a variety of other therapeutic areas. For more information, please visit http://www.durect.com/.
TRANSDUR(TM) is a trademark of DURECT Corporation. TRANSDUR- Bupivacaine is a drug candidate under development and has not been submitted or approved for commercialization by the US Food and Drug Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding DURECT's products in development including TRANSDUR-Bupivacaine and product development plans are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, DURECT's (and that of its third party collaborators where applicable) abilities to design, enroll, conduct and complete clinical trials, complete the design, development, and manufacturing process development of the product candidate, obtain product and manufacturing approvals from regulatory agencies and manufacture and commercialize the product candidate, as well as marketplace acceptance of the product candidate. Further information regarding these and other risks is included in DURECT's Form 10-Q dated November 3, 2006 under the heading "Risk Factors."
DURECT Corporation
http://www.durect.com/
DURECT's Phase I trial for TRANSDUR-Bupivacaine, initially reported on December 11, 2006, demonstrated good safety, tolerability and drug release for up to 3 days. TRANSDUR-Bupivacaine is intended to provide up to 3 days of pain relief for patients suffering from PHN, as compared to a wearing time limited to 12 hours with currently available patches.
"The initiation of the Phase II program for TRANSDUR-Bupivacaine is an important milestone for us," said James E. Brown, DURECT's President and CEO. "Based on our TRANSDUR technology, we believe that the product profile of TRANSDUR-Bupivacaine represents an improvement over existing pain control products for patients suffering from PHN."
DURECT's Phase II program for TRANSDUR-Bupivacaine has begun with a randomized, multi-center, double-blind, placebo controlled, two-way crossover trial in approximately 50 patients with PHN to assess safety as well as the magnitude, duration and characteristics of analgesic activity of TRANSDUR- Bupivacaine.
Bupivacaine, the active agent in TRANSDUR-Bupivacaine, is a potent, FDA- approved long-acting local anesthetic used in regional anesthesia including infiltration, nerve block, epidural and intrathecal anesthesia. Bupivacaine is a more potent sodium channel blocker and has a longer duration of action than lidocaine, the active ingredient for Lidoderm(R), the market leader for post- herpetic neuralgia pain management.
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceutical company focused on the development of pharmaceutical systems based on its proprietary drug delivery platform technologies focused on treating chronic and episodic diseases and conditions. The Company currently has a number of late-stage pharmaceutical products in development initially focused on significant unmet medical needs in pain management, with a number of research programs underway in a variety of other therapeutic areas. For more information, please visit http://www.durect.com/.
TRANSDUR(TM) is a trademark of DURECT Corporation. TRANSDUR- Bupivacaine is a drug candidate under development and has not been submitted or approved for commercialization by the US Food and Drug Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding DURECT's products in development including TRANSDUR-Bupivacaine and product development plans are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, DURECT's (and that of its third party collaborators where applicable) abilities to design, enroll, conduct and complete clinical trials, complete the design, development, and manufacturing process development of the product candidate, obtain product and manufacturing approvals from regulatory agencies and manufacture and commercialize the product candidate, as well as marketplace acceptance of the product candidate. Further information regarding these and other risks is included in DURECT's Form 10-Q dated November 3, 2006 under the heading "Risk Factors."
DURECT Corporation
http://www.durect.com/
Victory Pharma, Inc. Announces Investigational New Drug MGX-006 Approved By The FDA
Victory Pharma, Inc. announced today the U.S. Food and Drug Administration (FDA) completed its review for the company's Investigational New Drug (IND) application to evaluate MGX-006, a unique formulation of a currently marketed agent with indications for various nausea and vomiting conditions. The MGX-006 program is being supported via a co-development agreement between Victory and its technology partner signed in August of 2006. Upon regulatory approval, Victory intends to market the product through its proprietary U.S. based sales organization.
"MGX-006 emerged from our strategy to develop and acquire products utilized for the treatment of pain or pain-related illness," said Dave Gonyer, Vice President of Commercial Development for Victory Pharma. "Many patients who experience pain also experience nausea due to the disease state itself or the treatments for it. We believe that MGX-006 could provide a significant improvement to the treatment of nausea and vomiting and substantially improve compliance to benefit patients."
The successful initiation of a second development program represents an important milestone in Victory's evolution into a leading pain and related specialty pharmaceutical company. The anti-nausea market remains an area of unmet medical need with expanding market potential. Many anti-emetics are used concomitantly with pain products, and are often prescribed by Victory's target audiences for its current product portfolio. MGX-006 is targeted to enter pivotal trials in 2007 in conjunction with a leading clinical research organization.
About Victory Pharmaceuticals
Victory Pharma, Inc. is a private San Diego based specialty pharmaceutical company focused on acquiring, marketing and developing proprietary late stage pain and related products. Victory markets its existing pain products through its physician-based field sales force deployed throughout the U.S. The Company is developing several products in pain and pain complementary markets including MGX-001, for treatment of chronic severe pain and a commonly associated opiate-induced side effect. MGX-001 is currently in Phase II clinical testing in the United States.
Further information regarding Victory is available at http://www.VictoryPharma.com.
Victory Pharma, Inc.
http://www.VictoryPharma.com
"MGX-006 emerged from our strategy to develop and acquire products utilized for the treatment of pain or pain-related illness," said Dave Gonyer, Vice President of Commercial Development for Victory Pharma. "Many patients who experience pain also experience nausea due to the disease state itself or the treatments for it. We believe that MGX-006 could provide a significant improvement to the treatment of nausea and vomiting and substantially improve compliance to benefit patients."
The successful initiation of a second development program represents an important milestone in Victory's evolution into a leading pain and related specialty pharmaceutical company. The anti-nausea market remains an area of unmet medical need with expanding market potential. Many anti-emetics are used concomitantly with pain products, and are often prescribed by Victory's target audiences for its current product portfolio. MGX-006 is targeted to enter pivotal trials in 2007 in conjunction with a leading clinical research organization.
About Victory Pharmaceuticals
Victory Pharma, Inc. is a private San Diego based specialty pharmaceutical company focused on acquiring, marketing and developing proprietary late stage pain and related products. Victory markets its existing pain products through its physician-based field sales force deployed throughout the U.S. The Company is developing several products in pain and pain complementary markets including MGX-001, for treatment of chronic severe pain and a commonly associated opiate-induced side effect. MGX-001 is currently in Phase II clinical testing in the United States.
Further information regarding Victory is available at http://www.VictoryPharma.com.
Victory Pharma, Inc.
http://www.VictoryPharma.com
MRI Of The Ankle Changes Patient Treatment And Improves Referring Physician Confidence In Diagnosis
MR imaging can make a dramatic difference in the management of patients with ankle pain, changing treatment in about one-third of the patients, a new study finds.
The study, of 91 patients, found that MR changed the management plans of 35% of patients, said Philip W.P. Bearcroft, MD, of Cambridge University Hospitals in England. "This is itself is significant, but more significant is the fact that before an MRI was done, 65 of the 91 patients were scheduled to undergo surgery. After an MRI was done, nine of those patients were treated nonsurgically," Dr. Bearcroft said.
Dr. Bearcroft and his colleagues conducted the study in conjunction with an orthopedic foot and ankle surgeon at a regional teaching hospital. The surgeon noted his proposed treatment plan for each patient before and after an MR examination. The surgeon also noted the potential diagnoses for each injury. Before an MR examination was done, the surgeon indicated an average 2.3 possible diagnoses per patient. "After MRI was performed, the number of diagnoses per patient was reduced to 1.2," said Dr. Bearcroft. MRI increased the referring physician's confidence in his diagnoses, Dr. Bearcroft said. "In 66% of the MRI examinations performed, the referring surgeon felt that his understanding of the patient's disease had either depended upon or had been substantially improved by MRI," he added.
"This study is a bit different than the traditional radiological study," Dr. Bearcroft said. "Most studies relate to improving technique or look at the accuracy and predictive value of imaging techniques. This one was designed to determine if we really make a difference to the referring physician and the patient," he said.
The study appeared in a recent issue of the American Journal of Roentgenology, published by the American Roentgen Ray Society.
American Roentgen Ray Society (ARRS)
44211 Slatestone Ct.
Leesburg, VA 20176-5109 United States
http://www.arrs.org
The study, of 91 patients, found that MR changed the management plans of 35% of patients, said Philip W.P. Bearcroft, MD, of Cambridge University Hospitals in England. "This is itself is significant, but more significant is the fact that before an MRI was done, 65 of the 91 patients were scheduled to undergo surgery. After an MRI was done, nine of those patients were treated nonsurgically," Dr. Bearcroft said.
Dr. Bearcroft and his colleagues conducted the study in conjunction with an orthopedic foot and ankle surgeon at a regional teaching hospital. The surgeon noted his proposed treatment plan for each patient before and after an MR examination. The surgeon also noted the potential diagnoses for each injury. Before an MR examination was done, the surgeon indicated an average 2.3 possible diagnoses per patient. "After MRI was performed, the number of diagnoses per patient was reduced to 1.2," said Dr. Bearcroft. MRI increased the referring physician's confidence in his diagnoses, Dr. Bearcroft said. "In 66% of the MRI examinations performed, the referring surgeon felt that his understanding of the patient's disease had either depended upon or had been substantially improved by MRI," he added.
"This study is a bit different than the traditional radiological study," Dr. Bearcroft said. "Most studies relate to improving technique or look at the accuracy and predictive value of imaging techniques. This one was designed to determine if we really make a difference to the referring physician and the patient," he said.
The study appeared in a recent issue of the American Journal of Roentgenology, published by the American Roentgen Ray Society.
American Roentgen Ray Society (ARRS)
44211 Slatestone Ct.
Leesburg, VA 20176-5109 United States
http://www.arrs.org
Horizon Therapeutics Announces Special Protocol Assessment With FDA For Phase 3 Trial Program
Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) via a Special Protocol Assessment for the Phase 3 trial program of HZT-501, its "GI-friendly" prescription NSAID for mild-to-moderate pain relief.
The SPA agreement indicates that if the trials successfully meet their primary endpoint, the data will provide support for an efficacy claim in a marketing application to the FDA. The two trials are expected to begin patient enrollment in the first half of this year.
HZT-501 is a proprietary formulation of the world's most prescribed non-steroidal anti-inflammatory drug (NSAID) ibuprofen, combined with the most potent H2 receptor antagonist famotidine, in a single pill. HZT-501 is specifically designed to provide pain relief while reducing stomach acidity during the peak time of risk for ulceration. In a randomized pilot clinical study published in The New England Journal of Medicine (Taha, et. al May 1996), famotidine was demonstrated to significantly reduce the incidence of gastric and duodenal ulcers vs. placebo when administered with NSAIDs.
"While NSAID's provide excellent pain relief, they can cause serious gastrointestinal side effects such as ulcers," said Dr. Loren Laine, Keck School of Medicine of the University of Southern California. "This is an important medical issue, especially given data from studies that suggest that many patients at risk do not receive appropriate therapy. HZT-501 was designed with the specific goal of decreasing the GI injury associated with NSAID's."
Phase 3 Clinical Study
The Phase 3 program will comprise two trials involving a total of 1,200 patients with mild-to-moderate pain, including patients with osteoarthritis. Horizon Protocol HZ-CA-301 and HZ-CA-303 will evaluate the efficacy and safety of HZT-501 with a primary endpoint of reduction in the risk of development of ibuprofen-associated upper gastrointestinal ulcers in patients who require the use of ibuprofen.
The clinical trials will be multi-center, randomized, controlled, and blinded for up to 24 weeks of treatment, followed by a 4 week safety evaluation period. The studies will be conducted in the United States.
Horizon has successfully completed product development and early supportive clinical studies on HZT-501 necessary to begin Phase 3 trials including PK/PD formulation design, drug-drug interaction, and comparative bioavailability of HZT-501 to approved reference drug products.
"The SPA is a major milestone that solidifies what we believe is a clearly defined development and regulatory pathway to address this significant unmet medical need," said George F. Tidmarsh, M.D., Ph.D., co-founder and chief executive officer of Horizon Therapeutics. "In addition to HZT-501, we are building a pipeline of therapies through similar combinations of existing pharmaceutical products that offer the potential for rapid development and commercialization with relatively low risk."
Proof-of-concept
In the May 30, 1996 edition of the New England Journal of Medicine, an article, "Famotidine for the Prevention of Gastric and Duodenal Ulcers Caused by Non-steroidal Anti-inflammatory Drugs" was published by Taha, et. al. The study was a randomized, controlled trial including 285 arthritis patients. The primary endpoint was the measurement of the cumulative incidence of endoscopically diagnosed gastric and duodenal ulcers at 4, 12 and 24 weeks in patients treated with an NSAID alone vs. those treated with NSAID plus a total daily dose of either 40mg or 80mg of famotidine.
The cumulative incidence of gastric ulcers was 20% in the NSAID-alone group and 8% in the 40-mg BID (twice daily) famotidine plus NSAID group (p = 0.03). The cumulative incidence of duodenal ulcers was 13% in the NSAID-alone group and 2% in the 40-mg BID famotidine plus NSAID group (p = 0.01). There were also significantly lower rates of gastric and duodenal ulceration when analyzed separately and when combined (28% for the NSAID-alone group vs. 11% for the 40-mg BID famotidine plus NSAID group; p = 0.003).
About the Pain Market
HZT-501 targets the widespread product void in the mild-to-moderate pain market left by COX-2 inhibitors such as Vioxx(R), which have either been taken off the market or prescribed less frequently due to elevated cardiovascular risk. In 2005, the U.S. non-steroidal anti-inflammatory (NSAID) market grew over 20 percent to 73 million prescriptions. Over 26 million ibuprofen prescriptions are now written annually in the U.S. alone.
However, while commonly prescribed to treat pain, NSAIDs have been linked to serious gastrointestinal (GI) side effects in up to 25 percent of all chronic arthritis patients. NSAID-induced GI toxicity causes an estimated 16,000 deaths and more than 100,000 hospitalizations annually in the United States. Despite this, studies have shown that as low as 30% of high-risk patients are commonly co-prescribed a gastro-protective agent in combination with their NSAID to prevent or relieve side effects. In addition, patient adherence to a regimen of separate GI and pain medications has also been shown to be poor.
About Horizon Therapeutics
Horizon Therapeutics, Inc. is a late stage biopharmaceutical company focused on the rapid development and commercialization of therapeutic treatments for mild-to-moderate pain management. The Company is building a novel portfolio of therapies through innovative combinations of approved pharmaceutical products that seek to improve safety, efficacy, and patient compliance. Its lead product candidate, HZT-501, will enter Phase 3 trials in 2007. In addition to HZT-501, Horizon has a pipeline of follow-on pain combination products in earlier stages of development. For more information visit http://www.horizontherapeutics.com.
Horizon Therapeutics, Inc.
http://www.horizontherapeutics.com
The SPA agreement indicates that if the trials successfully meet their primary endpoint, the data will provide support for an efficacy claim in a marketing application to the FDA. The two trials are expected to begin patient enrollment in the first half of this year.
HZT-501 is a proprietary formulation of the world's most prescribed non-steroidal anti-inflammatory drug (NSAID) ibuprofen, combined with the most potent H2 receptor antagonist famotidine, in a single pill. HZT-501 is specifically designed to provide pain relief while reducing stomach acidity during the peak time of risk for ulceration. In a randomized pilot clinical study published in The New England Journal of Medicine (Taha, et. al May 1996), famotidine was demonstrated to significantly reduce the incidence of gastric and duodenal ulcers vs. placebo when administered with NSAIDs.
"While NSAID's provide excellent pain relief, they can cause serious gastrointestinal side effects such as ulcers," said Dr. Loren Laine, Keck School of Medicine of the University of Southern California. "This is an important medical issue, especially given data from studies that suggest that many patients at risk do not receive appropriate therapy. HZT-501 was designed with the specific goal of decreasing the GI injury associated with NSAID's."
Phase 3 Clinical Study
The Phase 3 program will comprise two trials involving a total of 1,200 patients with mild-to-moderate pain, including patients with osteoarthritis. Horizon Protocol HZ-CA-301 and HZ-CA-303 will evaluate the efficacy and safety of HZT-501 with a primary endpoint of reduction in the risk of development of ibuprofen-associated upper gastrointestinal ulcers in patients who require the use of ibuprofen.
The clinical trials will be multi-center, randomized, controlled, and blinded for up to 24 weeks of treatment, followed by a 4 week safety evaluation period. The studies will be conducted in the United States.
Horizon has successfully completed product development and early supportive clinical studies on HZT-501 necessary to begin Phase 3 trials including PK/PD formulation design, drug-drug interaction, and comparative bioavailability of HZT-501 to approved reference drug products.
"The SPA is a major milestone that solidifies what we believe is a clearly defined development and regulatory pathway to address this significant unmet medical need," said George F. Tidmarsh, M.D., Ph.D., co-founder and chief executive officer of Horizon Therapeutics. "In addition to HZT-501, we are building a pipeline of therapies through similar combinations of existing pharmaceutical products that offer the potential for rapid development and commercialization with relatively low risk."
Proof-of-concept
In the May 30, 1996 edition of the New England Journal of Medicine, an article, "Famotidine for the Prevention of Gastric and Duodenal Ulcers Caused by Non-steroidal Anti-inflammatory Drugs" was published by Taha, et. al. The study was a randomized, controlled trial including 285 arthritis patients. The primary endpoint was the measurement of the cumulative incidence of endoscopically diagnosed gastric and duodenal ulcers at 4, 12 and 24 weeks in patients treated with an NSAID alone vs. those treated with NSAID plus a total daily dose of either 40mg or 80mg of famotidine.
The cumulative incidence of gastric ulcers was 20% in the NSAID-alone group and 8% in the 40-mg BID (twice daily) famotidine plus NSAID group (p = 0.03). The cumulative incidence of duodenal ulcers was 13% in the NSAID-alone group and 2% in the 40-mg BID famotidine plus NSAID group (p = 0.01). There were also significantly lower rates of gastric and duodenal ulceration when analyzed separately and when combined (28% for the NSAID-alone group vs. 11% for the 40-mg BID famotidine plus NSAID group; p = 0.003).
About the Pain Market
HZT-501 targets the widespread product void in the mild-to-moderate pain market left by COX-2 inhibitors such as Vioxx(R), which have either been taken off the market or prescribed less frequently due to elevated cardiovascular risk. In 2005, the U.S. non-steroidal anti-inflammatory (NSAID) market grew over 20 percent to 73 million prescriptions. Over 26 million ibuprofen prescriptions are now written annually in the U.S. alone.
However, while commonly prescribed to treat pain, NSAIDs have been linked to serious gastrointestinal (GI) side effects in up to 25 percent of all chronic arthritis patients. NSAID-induced GI toxicity causes an estimated 16,000 deaths and more than 100,000 hospitalizations annually in the United States. Despite this, studies have shown that as low as 30% of high-risk patients are commonly co-prescribed a gastro-protective agent in combination with their NSAID to prevent or relieve side effects. In addition, patient adherence to a regimen of separate GI and pain medications has also been shown to be poor.
About Horizon Therapeutics
Horizon Therapeutics, Inc. is a late stage biopharmaceutical company focused on the rapid development and commercialization of therapeutic treatments for mild-to-moderate pain management. The Company is building a novel portfolio of therapies through innovative combinations of approved pharmaceutical products that seek to improve safety, efficacy, and patient compliance. Its lead product candidate, HZT-501, will enter Phase 3 trials in 2007. In addition to HZT-501, Horizon has a pipeline of follow-on pain combination products in earlier stages of development. For more information visit http://www.horizontherapeutics.com.
Horizon Therapeutics, Inc.
http://www.horizontherapeutics.com
Anesiva Announces Clinical Plan For Pivotal Testing Of 4975, Long-Acting Pain Candidate
Anesiva, Inc. (Nasdaq: ANSV) today outlined the planned Phase 2/3 clinical trial program for the development of 4975, the company's long-acting, non-opioid drug candidate for the acute treatment of severe pain. After a successful meeting with the FDA, the company will be focusing its near-term development efforts of 4975 in two areas-post-surgical pain and osteoarthritis.
In initial Phase 2 studies, 4975 was shown to provide a statistically significant reduction in the pain associated with total knee replacement surgeries and osteoarthritis of the knee for weeks to months following a single application. Anesiva anticipates commencing a series of clinical trials during the first half of this year to confirm the safety and efficacy of 4975. Following is a list of trials that are planned for the company's post-surgical and osteoarthritis indications:
Post-surgical
-- A 50-patient Phase 2 trial evaluating a higher dose of 4975 to reduce the pain associated with knee replacement surgeries (Begin in 1H07)
-- A 50-patient Phase 2 trial evaluating the safety and efficacy of 4975 to reduce the pain associated with hip replacement surgeries (Begin in 1H07)
-- A 50-patient Phase 2 trial evaluating the safety and efficacy of 4975 to reduce the pain associated with arthroscopic shoulder surgeries (Begin in 1H07)
-- A 450-patient Phase 3 trial evaluating the safety and efficacy of 4975 to reduce the pain associated with knee replacement surgeries (Begin in 2H07)
Osteoarthritis
-- A 200-patient Phase 2 trial evaluating the safety and efficacy of 4975 to reduce the pain associated with osteoarthritis of the knee (Begin in 1H07)
"We are eager to begin the next phase of our development to confirm our earlier findings of 4975, which has shown significant potential to treat debilitating pain in a number of indications without the substantial side effects associated with current opioid pain medications," stated John P. McLaughlin, chief executive officer of Anesiva. "We believe our Phase 2/3 program will provide an overview of the efficacy and safety profile of 4975 to treat pain associated with surgery and osteoarthritis."
How 4975 May Address Need for Long-Duration, Well-Tolerated Pain Relief
4975 is long-acting, with the potential to provide pain relief for weeks or months after just a single localized treatment. It is a non-opioid TRPV1 agonist with a unique mechanism of action that provides a long-lasting, localized effect on C-fibers and blocks the transmission of aching, throbbing pain caused by major surgical procedures and end-stage osteoarthritis. Because it selectively acts on pain-sensing nerve endings, 4975 does not affect other nerve fibers necessary for sensory or motor sensations, such as those needed to sense temperature or pressure.
In clinical studies to date, 4975 has not had the side effects often associated with other conventional pain medications and has been shown to be well tolerated. Opioid drugs, such as morphine, which are commonly used agents to relieve pain in post-surgical and musculoskeletal pain conditions, have significant side effects including sedation, respiratory depression, euphoria, and nausea and vomiting during acute use, and constipation and physical dependence during chronic use.
About Total Knee Replacement Surgery and Osteoarthritis of the Knee
Total knee replacement (also known as total knee arthroplasty) is performed in patients with end-stage osteoarthritis of the knee. These patients have disabling pain which imposes severe limitations on their mobility, and knee replacement is performed with the goal of restoring or improving patients' quality of life.
Osteoarthritis of the knee is a common, progressive disease in which the joint cartilage breaks down. This breakdown causes the bones to rub against each other resulting in stiffness, pain, and loss of movement in the joint. In advanced stages, the pain becomes intractable and disabling, limiting patients' mobility and activities. Approximately 1.1 million patients are candidates for knee replacement or aggressive non-surgical interventions to address the debilitating effects of end-stage osteoarthritis of the knee.
There were an estimated 470,000 total knee replacement procedures performed in the United States in 2005, and the number of replacements will continue to grow as the average age of the U.S. population increases and as these individuals conduct more active lives. The American Academy of Orthopedic Surgery projects that approximately 3.5 million of these procedures will be done each year by 2030.
Conference Call Details
Anesiva will conduct a webcast conference call with the investment community at 9:00 a.m. EST, today, January 8, 2007 to discuss the company's clinical trial plans for 4975. Interested parties can listen to the live audio webcast by dialing 877-266-9200 (international dial: 706-634-1538) or by logging on to http://www.anesiva.com and going to the Investor Information page. For those unable to participate via the Internet, a 24-hour replay will be available for seven days after the call by dialing 800-642-1687 (international dial: 706-645-9291) and giving the following pass code: 5711122.
About Anesiva
Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. Anesiva is based in South San Francisco, CA. For more information about Anesiva's leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to http://www.anesiva.com.
Forward Looking Statements
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include, without limitation, projected timing of FDA filings and clinical data announcements and other matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: whether Anesiva can successfully develop new products and the degree to which these gain market acceptance. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva's most recent quarterly report on Form 10-Q.
Anesiva undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.
Anesiva, Inc.
http://www.anesiva.com
In initial Phase 2 studies, 4975 was shown to provide a statistically significant reduction in the pain associated with total knee replacement surgeries and osteoarthritis of the knee for weeks to months following a single application. Anesiva anticipates commencing a series of clinical trials during the first half of this year to confirm the safety and efficacy of 4975. Following is a list of trials that are planned for the company's post-surgical and osteoarthritis indications:
Post-surgical
-- A 50-patient Phase 2 trial evaluating a higher dose of 4975 to reduce the pain associated with knee replacement surgeries (Begin in 1H07)
-- A 50-patient Phase 2 trial evaluating the safety and efficacy of 4975 to reduce the pain associated with hip replacement surgeries (Begin in 1H07)
-- A 50-patient Phase 2 trial evaluating the safety and efficacy of 4975 to reduce the pain associated with arthroscopic shoulder surgeries (Begin in 1H07)
-- A 450-patient Phase 3 trial evaluating the safety and efficacy of 4975 to reduce the pain associated with knee replacement surgeries (Begin in 2H07)
Osteoarthritis
-- A 200-patient Phase 2 trial evaluating the safety and efficacy of 4975 to reduce the pain associated with osteoarthritis of the knee (Begin in 1H07)
"We are eager to begin the next phase of our development to confirm our earlier findings of 4975, which has shown significant potential to treat debilitating pain in a number of indications without the substantial side effects associated with current opioid pain medications," stated John P. McLaughlin, chief executive officer of Anesiva. "We believe our Phase 2/3 program will provide an overview of the efficacy and safety profile of 4975 to treat pain associated with surgery and osteoarthritis."
How 4975 May Address Need for Long-Duration, Well-Tolerated Pain Relief
4975 is long-acting, with the potential to provide pain relief for weeks or months after just a single localized treatment. It is a non-opioid TRPV1 agonist with a unique mechanism of action that provides a long-lasting, localized effect on C-fibers and blocks the transmission of aching, throbbing pain caused by major surgical procedures and end-stage osteoarthritis. Because it selectively acts on pain-sensing nerve endings, 4975 does not affect other nerve fibers necessary for sensory or motor sensations, such as those needed to sense temperature or pressure.
In clinical studies to date, 4975 has not had the side effects often associated with other conventional pain medications and has been shown to be well tolerated. Opioid drugs, such as morphine, which are commonly used agents to relieve pain in post-surgical and musculoskeletal pain conditions, have significant side effects including sedation, respiratory depression, euphoria, and nausea and vomiting during acute use, and constipation and physical dependence during chronic use.
About Total Knee Replacement Surgery and Osteoarthritis of the Knee
Total knee replacement (also known as total knee arthroplasty) is performed in patients with end-stage osteoarthritis of the knee. These patients have disabling pain which imposes severe limitations on their mobility, and knee replacement is performed with the goal of restoring or improving patients' quality of life.
Osteoarthritis of the knee is a common, progressive disease in which the joint cartilage breaks down. This breakdown causes the bones to rub against each other resulting in stiffness, pain, and loss of movement in the joint. In advanced stages, the pain becomes intractable and disabling, limiting patients' mobility and activities. Approximately 1.1 million patients are candidates for knee replacement or aggressive non-surgical interventions to address the debilitating effects of end-stage osteoarthritis of the knee.
There were an estimated 470,000 total knee replacement procedures performed in the United States in 2005, and the number of replacements will continue to grow as the average age of the U.S. population increases and as these individuals conduct more active lives. The American Academy of Orthopedic Surgery projects that approximately 3.5 million of these procedures will be done each year by 2030.
Conference Call Details
Anesiva will conduct a webcast conference call with the investment community at 9:00 a.m. EST, today, January 8, 2007 to discuss the company's clinical trial plans for 4975. Interested parties can listen to the live audio webcast by dialing 877-266-9200 (international dial: 706-634-1538) or by logging on to http://www.anesiva.com and going to the Investor Information page. For those unable to participate via the Internet, a 24-hour replay will be available for seven days after the call by dialing 800-642-1687 (international dial: 706-645-9291) and giving the following pass code: 5711122.
About Anesiva
Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. Anesiva is based in South San Francisco, CA. For more information about Anesiva's leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to http://www.anesiva.com.
Forward Looking Statements
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include, without limitation, projected timing of FDA filings and clinical data announcements and other matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: whether Anesiva can successfully develop new products and the degree to which these gain market acceptance. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva's most recent quarterly report on Form 10-Q.
Anesiva undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.
Anesiva, Inc.
http://www.anesiva.com
April 15, 2007
Cephalon Announces Positive Results From Two Phase 3 Clinical Trials Of FENTORA(TM) In Breakthrough Pain
Cephalon, Inc. (Nasdaq: CEPH) today reported data from the first Phase 3 clinical trial to demonstrate positive results of FENTORA(TM) (fentanyl buccal tablet) [C-II] in opioid-tolerant patients with neuropathic pain. Onset of pain relief began in 10 minutes in this study as well as in a separate Phase 3 study in opioid- tolerant patients with cancer. The data from these studies will be submitted for presentation at a medical meeting in 2007.
One double-blind, placebo-controlled study assessed the efficacy of FENTORA in a variety of chronic conditions associated with neuropathic pain. The study involved 75 opioid-tolerant patients and demonstrated statistically significant improvement as measured on the primary endpoint, the Sum of Pain Intensity Differences at 60 minutes (p<0.0001). Statistically significant differences in pain relief compared with placebo were observed as early as 10 minutes (p<0.05), consistent with positive results from a previously announced study in opioid-tolerant patients with chronic low back pain. The medication was generally well tolerated with adverse events typical of opioids.
Similar results were reported for a second double-blind, placebo- controlled study that evaluated the onset of pain relief with FENTORA in 78 opioid-tolerant patients with cancer. Earlier clinical trials submitted as part of the FENTORA New Drug Application began evaluating pain relief at 15 minutes. This new study looked at earlier time points and demonstrated statistically significant differences in pain relief compared with placebo at 10 minutes (p<0.0001). The medication was generally well tolerated with adverse events typical of opioids.
"These new studies of FENTORA provide strong support for our clinical development strategy in breakthrough pain in additional chronic pain conditions," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "These data further suggest that, in opioid-tolerant patients, the onset of pain relief from FENTORA may be more rapid than indicated in the approved labeling."
FENTORA is currently approved by the FDA for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. At this time, it is not approved for the management of breakthrough pain associated with other chronic pain conditions. Cephalon expects to seek regulatory approval for an expansion of the labeled indications for FENTORA, which will include data from Phase 3 studies in patients with chronic pain conditions associated with breakthrough pain, such as neuropathic and low back pain.
Breakthrough Pain
Breakthrough pain is a component of chronic pain that is characterized by its rapid onset, moderate to severe intensity, and relatively short duration. It is estimated that 64 percent of patients with cancer - and 74 percent of patients with conditions other than cancer - who are treated for persistent pain will experience breakthrough pain.
FENTORA
Approved to manage breakthrough pain in opioid-tolerant patients with cancer, FENTORA's drug delivery system generates transient changes in pH that may optimize how well the tablet dissolves and how quickly the medicine passes across the lining of the cheek, or buccal mucosa. The most commonly observed adverse events seen in all FENTORA clinical studies are typical of opioid adverse events. Opioid adverse events should be expected and managed accordingly. In clinical trials of FENTORA, the most common (.10%) adverse events were nausea, dizziness, vomiting, fatigue, headache, constipation, somnolence, anemia, and dehydration. Most adverse events were mild to moderate in severity. No attempt was made to correct for concomitant use of around-the-clock opioids or cancer-related symptoms.
IMPORTANT WARNINGS AND SAFETY INFORMATION
FENTORA contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. FENTORA can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing FENTORA in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.
FENTORA is indicated for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Because life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients, FENTORA is contraindicated in the management of acute or postoperative pain. This product is not indicated for use in opioid non-tolerant patients.
Patients and their caregivers must be instructed that FENTORA contains a medicine in an amount which can be fatal to a child. Patients and their caregivers must be instructed to keep all tablets out of the reach of children (see Information for Patients and Their Caregivers contained within the prescribing information for disposal instructions).
Due to the higher bioavailability of fentanyl in FENTORA, when converting patients from other oral fentanyl products, including oral transmucosal fentanyl citrate (OTFC and Actiq(R)), to FENTORA, do not substitute FENTORA on a mcg-per-mcg basis and adjust doses as appropriate (see DOSAGE AND ADMINISTRATION contained within the prescribing information).
FENTORA is intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.
Full prescribing information about FENTORA, including a boxed warning, is available from http://www.FENTORA.com or Cephalon Professional Services and Medical Information (1-800-896-5855)
Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon's European headquarters are located in Maisons-Alfort, France.
The company currently markets six proprietary products in the United States: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA, TRISENOX(R) (arsenic trioxide) injection, VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II], and numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products, including any expansion of the labeled indications for FENTORA; interpretation of clinical results, including the results of the clinical trials of FENTORA in patients discussed above; prospects for regulatory approval; market prospects for its product; sales and earnings guidance; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
Cephalon, Inc.
http://www.cephalon.com
One double-blind, placebo-controlled study assessed the efficacy of FENTORA in a variety of chronic conditions associated with neuropathic pain. The study involved 75 opioid-tolerant patients and demonstrated statistically significant improvement as measured on the primary endpoint, the Sum of Pain Intensity Differences at 60 minutes (p<0.0001). Statistically significant differences in pain relief compared with placebo were observed as early as 10 minutes (p<0.05), consistent with positive results from a previously announced study in opioid-tolerant patients with chronic low back pain. The medication was generally well tolerated with adverse events typical of opioids.
Similar results were reported for a second double-blind, placebo- controlled study that evaluated the onset of pain relief with FENTORA in 78 opioid-tolerant patients with cancer. Earlier clinical trials submitted as part of the FENTORA New Drug Application began evaluating pain relief at 15 minutes. This new study looked at earlier time points and demonstrated statistically significant differences in pain relief compared with placebo at 10 minutes (p<0.0001). The medication was generally well tolerated with adverse events typical of opioids.
"These new studies of FENTORA provide strong support for our clinical development strategy in breakthrough pain in additional chronic pain conditions," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "These data further suggest that, in opioid-tolerant patients, the onset of pain relief from FENTORA may be more rapid than indicated in the approved labeling."
FENTORA is currently approved by the FDA for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. At this time, it is not approved for the management of breakthrough pain associated with other chronic pain conditions. Cephalon expects to seek regulatory approval for an expansion of the labeled indications for FENTORA, which will include data from Phase 3 studies in patients with chronic pain conditions associated with breakthrough pain, such as neuropathic and low back pain.
Breakthrough Pain
Breakthrough pain is a component of chronic pain that is characterized by its rapid onset, moderate to severe intensity, and relatively short duration. It is estimated that 64 percent of patients with cancer - and 74 percent of patients with conditions other than cancer - who are treated for persistent pain will experience breakthrough pain.
FENTORA
Approved to manage breakthrough pain in opioid-tolerant patients with cancer, FENTORA's drug delivery system generates transient changes in pH that may optimize how well the tablet dissolves and how quickly the medicine passes across the lining of the cheek, or buccal mucosa. The most commonly observed adverse events seen in all FENTORA clinical studies are typical of opioid adverse events. Opioid adverse events should be expected and managed accordingly. In clinical trials of FENTORA, the most common (.10%) adverse events were nausea, dizziness, vomiting, fatigue, headache, constipation, somnolence, anemia, and dehydration. Most adverse events were mild to moderate in severity. No attempt was made to correct for concomitant use of around-the-clock opioids or cancer-related symptoms.
IMPORTANT WARNINGS AND SAFETY INFORMATION
FENTORA contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. FENTORA can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing FENTORA in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.
FENTORA is indicated for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Because life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients, FENTORA is contraindicated in the management of acute or postoperative pain. This product is not indicated for use in opioid non-tolerant patients.
Patients and their caregivers must be instructed that FENTORA contains a medicine in an amount which can be fatal to a child. Patients and their caregivers must be instructed to keep all tablets out of the reach of children (see Information for Patients and Their Caregivers contained within the prescribing information for disposal instructions).
Due to the higher bioavailability of fentanyl in FENTORA, when converting patients from other oral fentanyl products, including oral transmucosal fentanyl citrate (OTFC and Actiq(R)), to FENTORA, do not substitute FENTORA on a mcg-per-mcg basis and adjust doses as appropriate (see DOSAGE AND ADMINISTRATION contained within the prescribing information).
FENTORA is intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.
Full prescribing information about FENTORA, including a boxed warning, is available from http://www.FENTORA.com or Cephalon Professional Services and Medical Information (1-800-896-5855)
Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon's European headquarters are located in Maisons-Alfort, France.
The company currently markets six proprietary products in the United States: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA, TRISENOX(R) (arsenic trioxide) injection, VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II], and numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products, including any expansion of the labeled indications for FENTORA; interpretation of clinical results, including the results of the clinical trials of FENTORA in patients discussed above; prospects for regulatory approval; market prospects for its product; sales and earnings guidance; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
Cephalon, Inc.
http://www.cephalon.com
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