News
Clinical Data on Somaxon Pharmaceuticals' Product Candidate for the Treatment of Insomnia Presented at American Psychiatric Association Annual Meeting
Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), 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, today announced that data from three Phase 3 clinical trials of the company's product candidate SILENOR(TM) (doxepin HCl) for the treatment of insomnia were presented today at the American Psychiatric Association (APA) 161st annual meeting in Washington, D.C.
The data presented at the APA meeting are a subset of the data from Somaxon's completed Phase 3 development program, which comprised four Phase 3 clinical trials evaluating SILENOR(TM), a low-dose (1-6 mg) formulation of doxepin for the treatment of insomnia. As the company has previously reported, all of these clinical trials demonstrated statistically significant differences relative to placebo for their primary endpoints and multiple secondary endpoints. The clinical trials demonstrated significant and clinically meaningful improvements in sleep onset, sleep maintenance and the prevention of early morning awakenings. In addition, the side effect profile was comparable to placebo, and there were no reports of amnesia, hallucinations or complex sleep behaviors. There were no next-day residual effects found at what are expected to be the recommended starting doses, and there was no apparent evidence of anticholinergic effects (e.g., dry mouth), tolerance, rebound insomnia, withdrawal effects or weight gain as compared to placebo.
"While several prescription products for the treatment of insomnia have become available in recent years, we believe that a need remains for a medication that helps people fall asleep and stay asleep throughout the night without next-day residual effects or risk of dependence," said David F. Hale, Somaxon's executive chairman and interim chief executive officer. "We believe that based on the clinical profile of low-dose doxepin demonstrated by the data presented today at the APA annual meeting and otherwise publicly announced by us, SILENOR(TM) can be an attractive treatment alternative for physicians and the insomnia patients they treat, if it is approved by the FDA."