The American Journal Of Psychiatry Publishes Data On Clinical Trial Of Nalmefene In The Treatment Of Pathological Gambling
SAN DIEGO, Feb. 3 /PRNewswire-FirstCall/ -- Somaxon Pharmaceuticals, Inc. , a specialty pharmaceutical company focused on the in-licensing and development of product candidates for the treatment of psychiatric and neurological disorders, today said that the February 2006 issue of the American Journal of Psychiatry features an article which describes the conduct and results of a four-month clinical trial investigating the efficacy and safety of one of its product candidates, oral nalmefene hydrochloride, an opioid antagonist, in reducing pathological gambling-related urges, thoughts and behaviors.
BioTie Therapies Corp. of Finland sponsored the trial, which was completed in April 2003. In November 2004, Somaxon entered into an exclusive license with BioTie to certain patents to develop, manufacture, and market nalmefene in North America.
The author of the article, Jon Grant, M.D., J.D. at the University of Minnesota, was a lead investigator in the trial. The randomized, placebo-controlled, double-blind, multi-center trial included 207 subjects diagnosed as pathological gamblers. The trial compared three doses of nalmefene (25 mg, 50 mg and 100 mg/day) to placebo. The primary endpoint consisted of mean change from baseline on the Yale Brown Obsessive Compulsive Scale modified for Pathological Gambling, a clinician-administered questionnaire for assessing gambling thoughts/urges and behavior. Subjects who received nalmefene had a statistically significant reduction in severity of pathological gambling. The 25 mg nalmefene dose appeared to be efficacious and was better tolerated than the 50 mg and 100 mg doses.
Somaxon is currently enrolling patients in an ongoing, multi-center Phase II/III clinical trial investigating the use of oral nalmefene for this indication. Information regarding nalmefene clinical trials sponsored by Somaxon may be found on the website www.clinicaltrials.gov.
About Pathological Gambling
Impulse control disorders affect millions of Americans and have been recognized by the Diagnostic and Statistical Manual of Mental Disorders as a clinical diagnosis since 1980. The Diagnostic and Statistical Manual of Mental Disorders -- Fourth Edition, published by the American Psychiatric Association, is the standard reference manual used to classify and diagnose mental disorders. The impulse control disorder category includes pathological gambling, kleptomania, pyromania, intermittent explosive disorder and compulsive buying. The University of Chicago's 1999 Gambling Impact and Behavior Study estimates that in the United States alone, there are approximately 2.5 million pathological gamblers, 3 million problem gamblers and an additional 15 million people who are at-risk for pathological gambling. There is also growing evidence of problematic adolescent gambling. The Gambling Impact and Behavior Study of 1999 found that approximately 3.5% of 16 to 17 year-olds could be considered at-risk, problem or pathological gamblers. In particular, the pervasiveness of internet gambling is a potential facilitating factor in youth gambling. Other disorders such as intermittent explosive disorder and compulsive buying are also significant problems. According to Datamonitor, potentially 6.4 million persons in the United States suffer from intermittent explosive disorder. Although estimates of the market for compulsive buying vary widely, based on a report in the 2004 Annals of Clinical Psychiatry; we believe the prevalence of this disorder ranges from 1.1% to 5.9% of American adults, or 2.4 to 13.0 million American adults.
About Somaxon Pharmaceuticals
Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology. Somaxon's lead product candidate, SILENOR(TM) (doxepin hydrochloride), is in Phase III clinical trials for the treatment of insomnia.
Meg McGilley, Chief Financial Officer (858.509.3670), or Rob Whetsone, PondelWilkinson, Inc. (310.279.5980) or visit the company's website at www.somaxon.com.
Somaxon cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Somaxon that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Somaxon's business, including, without limitation: the progress and timing of clinical trials, including for nalmefene and Somaxon's other product candidates; unexpected adverse side effects or inadequate therapeutic efficacy of nalmefene or Somaxon's other product candidates that could delay or prevent regulatory approval, product development or commercialization, or that could result in product liability claims; the scope and validity of patent protection for nalmefene and Somaxon's other product candidates; the market potential for impulse control disorders and Somaxon's other target markets, and Somaxon's ability to compete; and other risks detailed in Somaxon's prior press releases as well as in public periodic filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Somaxon undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.Somaxon Pharmaceuticals, Inc.
CONTACT: Meg McGilley, Chief Financial Officer of Somaxon Pharmaceuticals,Inc., +1-858-509-3670; or Rob Whetsone of PondelWilkinson, Inc.,+1-310-279-5980, for Somaxon Pharmaceuticals, Inc.