Medical Blogs

May 7, 2007

Pharmos Announces Clinical Data From Phase 2a Trial Of Cannabinor For Capsaicin-induced Pain

Pharmos Corp. (Nasdaq: PARS) today announced preliminary results from its Phase 2a study evaluating intravenous (i.v.) cannabinor, a CB2-selective synthetic cannabinoid compound, in a capsaicin-induced pain model. The drug candidate did not meet the primary endpoint defined by analgesic effects compared to placebo, but confirmed safety and tolerability observed in previous studies. All subjects completed the treatment with no serious adverse events or significant cardiovascular effects.

The randomized, double-blinded, two-way crossover study enrolled 24 healthy male volunteers to compare 48mg of cannabinor delivered intravenously versus placebo on capsaicin-evoked allodynia (pain resulting from a non- noxious stimulus to the skin) and hyperalgesia (abnormally increased pain sense).

"While we are disappointed that cannabinor did not show efficacy in this pain model, we have a newly developed oral formulation of cannabinor targeting chronic neuropathic pain with repeated administration," said Dr. Haim Aviv, Chairman & CEO. "We plan to move forward with the program for orally administered cannabinor, and our next step is to conduct a Phase I safety trial in healthy volunteers. Based on preclinical results of oral cannabinor, its prospects as a potential treatment for neuropathic pain are promising." Pharmos recently completed preclinical toxicology and safety pharmacology studies of oral cannabinor, the data from which support initiation of Phase 1 testing.

The Company expects to complete its separate, ongoing Phase 2a clinical trial of cannabinor as a treatment for nociceptive pain in the first quarter of 2007. The single-center, randomized, double-blinded, single-administration study compares different i.v. doses of cannabinor with placebo. The completed study will involve 100 healthy male subjects experiencing pain following third molar dental extraction.

About Cannabinor and CB2-Selective Cannabinoids

Cannabinor has demonstrated efficacy in a number of preclinical animal models of pain, inflammation and autoimmune disease. Analgesic activity has been documented in nociceptive, neuropathic, visceral and inflammatory pain in rodents and in post-operative pain in a porcine surgery model. The magnitude of analgesia was generally equivalent or greater than that of accepted comparator agents, including morphine, non-steroidal anti-inflammatory drugs and Gabapentin. In a number of models where duration of analgesia was measured, cannabinor remained effective at reducing pain significantly longer than morphine. Preliminary evidence from preclinical studies also suggests that tolerance to the therapeutic effect of cannabinor might not occur. A drug that remains effective without increasing dosage would be a valuable advance in treating severe pain.

Pharmos' cannabinoid research focus has been geared toward the development of selective and specific CB2 receptor agonists. Because they range from having little (CB2-selective) to barely detectable (CB2-specific) affinity for the central nervous system-located CB1 receptor, CB2-selective and -specific agonists lack the unwanted psychotropic side effects of many natural cannabinoids. CB2 agonists bind to CB2 receptors, which are located on immune and inflammatory cells. By activating CB2 receptors, CB2 agonists inhibit autoimmune and inflammatory processes, and are likely to be useful for treating pain, autoimmune, inflammatory and degenerative disorders. Pharmos is developing its CB2 agonists as treatments for chronic pain and autoimmune diseases, such as multiple sclerosis and rheumatoid arthritis. Cannabinor is the first lead candidate to emerge from this body of Pharmos' proprietary technology.

About Pharmos Corporation

Pharmos discovers and develops novel therapeutics to treat a range of indications with a focus on specific diseases of the nervous system including disorders of the brain-gut axis (gastrointestinal/irritable bowel syndrome (IBS)), pain/inflammation, and autoimmune disorders. The Company's lead product, dextofisopam, has completed Phase 2a testing in IBS, with positive effect on the primary efficacy endpoint (n=141, p=0.033). The Company plans a Phase 2b study of dextofisopam for the treatment of IBS in 2007. The Company's core proprietary technology platform focuses on discovery and development of synthetic cannabinoid compounds. Cannabinor and other CB2 agonist compounds in Pharmos' pipeline are in clinical and pre-clinical studies targeting pain, multiple sclerosis, rheumatoid arthritis and other disorders. Pharmos is also working to commercialize its unique proprietary NanoEmulsion drug delivery system, which is in clinical stage development for topical application of analgesic and anti-inflammatory agents.

Pharmos Corp.

Long-Term Narcotics Use For Back Pain May Be Ineffective And Lead To Abuse

Narcotic drugs (opioids) are commonly prescribed for short-term relief of chronic back pain, but their effectiveness long-term has been questioned in a review article by researchers at Yale School of Medicine, who also found that behaviors consistent with opioid abuse was reported in 24 percent of cases.

"Patients with chronic back pain commonly request pain medication, and opioid medications are used despite the concerns clinicians have with patients developing an addiction to these medications," said first author Bridget Martell, M.D., assistant clinical professor of general internal medicine at Yale School of Medicine. "Our findings suggest that clinicians should consider other treatments with similar benefits but fewer long-term adverse effects."

Published in the January 16 Annals of Internal Medicine, Martell and co-authors conducted a systematic literature review and meta-analysis that addressed the prevalence and effectiveness of opioid prescriptions for patients with chronic back pain, and the incidence of substance abuse disorders among patients receiving opioid medications for chronic back pain.

The study populations consisted of non-obstetric patients over age 18 with non-malignant chronic back pain lasting for at least three months. The research focused on efficacy of oral, transdermal, or topical opioids, where there was no pre-existing diagnosis of opioid dependence. According to the report, opioids may be effective for the short-term (less than four months) treatment of chronic low back pain, but long-term effectiveness was not conclusive.

"Our results also demonstrate that the quality of the literature on these topics is generally weak and more studies need to be done before firm conclusions can be made," said Martell.


In addition to Martell and corresponding author David Fiellin, M.D., associate professor of general internal medicine at Yale, other authors on the study included Patrick G. O'Connor, M.D., Robert D. Kerns, William C. Becker, M.D., Knashawn H. Morales and Thomas R. Kosten, M.D.

Citation: Annals of Internal Medicine, Vol. 146, No. 2 (January 16, 2007)

Yale News Releases are available via the World Wide Web at

For further information please go to:
Yale University

Childhood Obesity Linked To Foot Pain

January 17, 2007) Doctors with the American College of Foot and Ankle Surgeons (ACFAS) say they're noticing more and more overweight and obese children with foot and ankle pain in their examining rooms, mirroring a national epidemic of childhood obesity.

An estimated 16 percent of U.S. children ages six to 19 are overweight. Poor diet, lack of exercise and genetics can play a role. A "vicious cycle" of foot pain and obesity traps some children.

"You want overweight children to exercise and lose weight, but because of their weight, their feet hurt and they can't exercise," says Thanh Dinh, DPM, FACFAS, a foot and ankle surgeon in Boston.

The foot is a complex structure consisting of 26 bones, 33 joints and more than 100 muscles, tendons and ligaments. Last November, researchers in Britain reported "alarming new evidence that childhood obesity changes foot structure and results in instability when walking." Being overweight flattens the foot, straining the plantar fascia, a band of tissue which runs from the heel to the base of the toes, causing heel pain.

Because the heel bone is not fully developed until age 14 or older, overweight children are more prone to Sever's disease. Although not an actual disease, according to, it involves an inflammation of the heel's growth plate due to muscle strain and repetitive stress. Walking makes the pain worse. Being overweight may also cause stress fractures, or hairline fractures (breaks) in a child's heel bone.

Arch pain afflicts many of the children treated by Darryl Haycock, DPM, FACFAS. The northwest Ohio foot and ankle surgeon says the average age of these boys and girls ranges from eight to 12, but he's treated some as young as four.

"The numbers are definitely increasing. I treat four to five overweight children a week," he says.

Haycock notes some overweight children suffer foot pain from congenital or inherited foot conditions, such as bunions, hammertoes, pediatric flatfoot and tarsal coalition, an abnormal connection between two or more bones in the back of the foot. Children with these deformities may be less active because of pain. Sometimes a child will complain of calf or arch pain. This results from a flatfoot that is flexible. The collapsing of the arch can require more energy, making it more difficult for a child to walk and run.

Foot and ankle surgeons treat many overweight children with custom orthotic devices (shoe inserts), physical therapy and other conservative measures to reduce or eliminate pain. But treating painful feet and ankles is only part of the childhood weight loss equation, says Samuel Nava, DPM, FACFAS. The suburban Dallas surgeon has treated weight-related foot problems in toddlers to teenagers.

"As foot and ankle surgeons, we can reduce the aches and pains so these children can run around and play like all the other kids, but parents need to watch their childrens' lifestyles and diets," he says.

For more information on pediatric foot and ankle conditions, or to find a foot and ankle surgeon, visit the ACFAS patient information Web site,

The American College of Foot and Ankle Surgeons (ACFAS) is a professional society of more than 6,000 foot and ankle surgeons. Founded in 1942, the College's mission is to promote research and provide continuing education for the foot and ankle surgical specialty, and to educate the general public on foot health and conditions of the foot and ankle through its consumer website,

American College of Foot and Ankle Surgeons
8725 W. Higgins Rd., #555
Chicago, IL 60631
United States

Leading Radiofrequency Manufacturer Introduces A New Product For Treating Heel Pain

NeuroTherm, Inc., a global leader in radiofrequency generators for chronic pain management, announces the introduction of an RF product specifically for the podiatric market: The PodiaTherm RF Generator, designed to treat chronic heel pain, which often is associated with plantar fasciitis.

Plantar fasciitis, or inflammation of the plantar fascia, is considered the most common cause of heel pain. The plantar fascia is a ligament connecting the heel bone to the toes and supporting the arch of the foot. If strained, it can develop small tears and be weakened, swollen or irritated, thus resulting in pain while walking or standing.

"As many as two million Americans are affected by plantar fasciitis each year," says William Rittman, NeuroTherm's Chief Technology Officer. "Of those, approximately 10 percent require advanced treatment because conventional therapies, such as over-the-counter medications, splints and rest, haven't alleviated the pain. That's where PodiaTherm can help."

The PodiaTherm employs radiofrequency therapy to block the pain by affecting the nerve causing the pain, Rittman says. Basically, the physician isolates the sensory nerve, which is a branch of the lateral plantar nerve, and inserts an RF electrode. The PodiaTherm then transmits a signal through the electrode, creating a lesion on the nerve in a process called thermoneurolysis.

"Once conventional therapies have been exhausted, patients have had fewer treatment options other than surgery. This will be a minimally invasive, office-based procedure," says Laurence Hicks, NeuroTherm CEO and President. Previously, advanced, non-surgical therapies either required bruising the tendons with shockwaves or making an inch-long incision to treat the tendon internally. The PodiaTherm requires only a local anesthetic and a needle's width incision. The RF therapy can be performed in a physician's office, at a hospital or in a surgery center.

"RF therapy with the PodiaTherm will become the treatment of choice for many podiatrists and patients, particularly because it's a simple, effective and safe procedure," Hicks states.

According to Rittman, radiofrequency therapy has been used successfully for many years to treat chronic pain. The RF procedure is commonly reimbursed through insurance. It also will cost less than other non-conventional therapies.

Moreover, the PodiaTherm is a small machine, so it can be transported easily from one facility to the next as the physician requires.

NeuroTherm, Inc. is a leading manufacturer of radiofrequency generators and related consumables used in the treatment of chronic pain. The company recently introduced the NT1000, the world's first RF generator capable of producing three lesions simultaneously. NeuroTherm also pioneered the development and use of disposable electrodes in the U.K. market.

NeuroTherm is based in Middleton, MA., with another facility outside London, England. The company was formed in September 2005, as a concurrent acquisition of RDG Medical in the U.K., and RF Medical and Precision Medical Engineering in the U.S. by Cortec Group Fund III, L.P., an affiliate of Cortec Group, Inc. Additional information about NeuroTherm can be found on the Internet at

Additional information about the PodiaTherm RF Generator can be found on the Internet at

NeuroTherm, Inc.

April 16, 2007

Consumers Should Talk To Their Pharmacists About Pain Reliever Safety Pharmacists Can Answers Questions If Consumers Have Concerns

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

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:

American Chiropractic Association

'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

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

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

Johns Hopkins University School of Nursing
525 North Wolfe St, Rm 525
Baltimore, MD 21205
United States

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

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