понедельник, 18 апреля 2011 г.

Clinical Trial Of Nalmefene In The Treatment Of Pathological Gambling

Somaxon Pharmaceuticals, Inc.
(Nasdaq: SOMX), 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 clinicaltrials.


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.

somaxon


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.

somaxon

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