Somaxon Pharmaceuticals Reports Positive Results From A Pilot Phase 2 Study Of Oral Nalmefene In Smoking Cessation
08/28/06
Somaxon Pharmaceuticals,
Inc. (Nasdaq: SOMX) today announced that oral nalmefene hydrochloride, an
opiate antagonist under development by the company, demonstrated positive
results in a pilot Phase 2 clinical trial for smoking cessation. In a
single
Somaxon Pharmaceuticals,
Inc. (Nasdaq: SOMX) today announced that oral nalmefene hydrochloride, an
opiate antagonist under development by the company, demonstrated positive
results in a pilot Phase 2 clinical trial for smoking cessation. In a
single center, randomized, placebo-controlled study in which 76 smokers
were enrolled, patients in the nalmefene 40mg group demonstrated
numerically higher abstinence rates at all timepoints relative to placebo.
Patients in the nalmefene 80mg group did not consistently achieve
abstinence rates that were numerically superior to placebo. The study was
not powered to demonstrate statistical significance.
Nalmefene was generally well tolerated, with an adverse event profile
similar to that observed in studies previously conducted with nalmefene.
The most commonly reported adverse events were insomnia and nausea. The
adverse events tended to be transient in nature and largely resolved after
the first week on study drug. Elevation in liver enzymes was observed with
a similar frequency in all groups.
Somaxon's Chief Medical Officer Phil Jochelson, MD commented, "We are
encouraged by the results of our first smoking cessation clinical study
which was designed to be exploratory in nature. We are intrigued with the
observation that the nalmefene 40 mg treated patients maintained higher
abstinence rates relative to placebo."
Ken Cohen, Somaxon's President and Chief Executive Officer commented,
"Nalmefene is a promising compound. We are currently studying this product
in a large clinical trial for the treatment of pathological gambling. We
intend to await the results of that trial, which we expect early next year,
before we determine our further clinical development plans. The results of
this pilot smoking cessation trial give us the opportunity to potentially
develop nalmefene for multiple indications in large markets with unmet
medical needs."
About Smoking
Cigarette smoking remains the leading preventable cause of illness and
premature death in the United States. In 2005, the U.S. Centers for Disease
Control and Prevention estimated that approximately 45 million, or 22%, of
adults in the United States are smokers. The impact of nicotine dependence
in terms of morbidity, mortality and economic costs to society is enormous.
According to the Surgeon General, tobacco usage kills more than 440,000
people in the United States annually. Smoking is linked to an estimated $75
billion in medical expenditures in the United States per year. When
indirect costs such as lost productivity due to smoking are considered, the
costs increase significantly to approximately $158 billion. Nearly 41% of
smokers attempt to quit smoking each year but only about 10% achieve and
maintain abstinence.
About Nalmefene
Nalmefene, an opioid antagonist, is approved and has been used for over
10 years in the United States in an intravenous form for the reversal of
opioid drug effects. Somaxon in-licensed the North American development and
commercial rights to an oral form of nalmefene and patents for its use in
the treatment of impulse control disorders, nicotine dependence and other
conditions. The impulse control disorder category includes a number of
serious conditions, including pathological gambling, kleptomania,
pyromania, intermittent explosive disorder and compulsive buying. There are
no FDA approved therapies for any of these disorders. 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 gamblers. In a multi-center Phase 2 clinical trial
conducted by Somaxon's licensor, nalmefene was shown to be statistically
superior to placebo in limiting gambling behavior and reducing the
frequency and intensity of gambling thoughts/urges. Based on these results,
Somaxon has initiated a confirmatory Phase 2/3 clinical trial for
pathological gambling. The company expects results from the pathological
gambling trial to be available in early 2007.
About Somaxon Pharmaceuticals, Inc.
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 HCl), is in Phase 3 clinical trials
for the treatment of insomnia. Nalmefene HCl is in a Phase 2/3 clinical
trial for pathological gambling and has completed a pilot Phase 2 trial for
smoking cessation. Acamprosate Ca, a potential treatment for movement
disorders, is currently in formulation development.
For more information, please visit the company's web site at