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Somaxon Pharmaceuticals, Inc. Initiates Second Phase III Clinical Trial of SILENOR(TM) -- Product Will Be Evaluated in Long-Term Trial of Elderly Patients With Primary Chronic Insomnia

Posted on: Tuesday, 20 September 2005, 09:00 CDT

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, today announced that enrollment has begun in the second Phase III clinical trial of SILENOR(TM) (doxepin hydrochloride) for the treatment of insomnia. This multi-center, placebo-controlled Phase III clinical trial will evaluate the safety and efficacy of SILENOR(TM) over a three month period in elderly patients diagnosed with primary chronic insomnia. The primary endpoint of the trial is Wake After Sleep Onset (WASO), the sleep maintenance endpoint recommended by the FDA. Multiple secondary efficacy endpoints will be evaluated, both objectively and through patient-reported outcomes.

Philip Jochelson, MD, Somaxon's Chief Medical Officer, commented, "In our Phase II dose-finding trial in elderly patients with sleep maintenance insomnia, we observed statistically significant improvements with respect to sleep duration and sleep maintenance. These effects persisted and were statistically significant even at hours seven and eight, without demonstrating impairment in measures of next-day residual effects relative to placebo. Based on these encouraging results, we have decided to further evaluate the safety and efficacy of SILENOR(TM) in this Phase III clinical trial in the elderly. To our knowledge, this trial is the first randomized, placebo-controlled, double-blind, sleep laboratory study to evaluate the long-term efficacy of a sedative hypnotic."

Ken Cohen, Somaxon's President and CEO, commented, "Prevalence of insomnia tends to increase as people age. In particular, the elderly frequently suffer from insomnia characterized by difficulty maintaining sleep throughout the night or waking too early. We hope to demonstrate a significant improvement in a variety of measures of insomnia in the SILENOR(TM) Phase III clinical trials in elderly patients. In addition, and importantly, the active ingredient in SILENOR(TM) is non-addictive and therefore, unlike all products currently approved to treat insomnia characterized by difficulty maintaining sleep, it is not a Schedule IV controlled substance."

About Somaxon

Headquartered in San Diego, Somaxon Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on in-licensing, developing and commercializing products for the treatment of diseases and disorders in the fields of psychiatry and neurology. To date, the company has licensed three product candidates. Somaxon's lead product candidate, SILENOR(TM) (doxepin hydrochloride), is in Phase III clinical trials for the treatment of insomnia. The company's product candidate nalmefene hydrochloride is in a Phase II/III clinical trial for the treatment of pathological gambling and a Phase II clinical trial for smoking cessation. The company is also developing a new formulation of acamprosate calcium for the treatment of movement disorders.

Somaxon cautions you that statements included in this press release that are not a description of historical facts may be 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, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its product candidates that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; the scope and validity of patent protection for its product candidates; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. 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.

Source: Business Wire

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