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
April 16, 2007
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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