SAN DIEGO, June 20 /PRNewswire-FirstCall/ -- Somaxon Pharmaceuticals, Inc. today announced that data from its Phase 2 clinical trial evaluating three doses of SILENOR(TM) (doxepin HCL) in elderly adults with insomnia will be presented at the SLEEP 2006 Annual Meeting of the Associated Professional Sleep Societies. The data will be presented by Thomas Roth, Ph.D., Chief, Division Head of the Sleep Disorders & Research Center at Henry Ford Hospital, at the Salt Palace Convention Center in Salt Lake City on Thursday, June 22. The presentation, titled: “Efficacy and Safety of Doxepin 1, 3, and 6mg in Elderly Adults with Primary Insomnia,” will take place at 9:45 a.m. in Ballroom FH.
Data from this study suggest that doxepin 1, 3, and 6mg may improve sleep maintenance, sleep duration, and sleep onset in elderly adults with primary insomnia. Doxepin 1, 3, and 6mg was shown to be well-tolerated and produced dose-related significant improvement in PSG-defined and patient-reported sleep maintenance and duration endpoints. The effect persisted through the final third-of-the-night with no reported anticholinergic effects or significant hangover/next-day residual effects. Effects on sleep onset were also observed at the highest doses.
Somaxon initially reported results from this Phase 2 clinical trial in April of 2005. In April 2006, Somaxon also reported results from its initial Phase 3 clinical trial of SILENOR(TM) for the treatment of adults with chronic insomnia.
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 hydrochloride), 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 in 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 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, Somaxon’s ability to attract and retain key personnel, the progress and timing of clinical trials and product development efforts 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.
Contacts: Meg McGilley Chief Financial Officer (858) 509-3670 Rob Whetstone PondelWilkinson, Inc. (310) 279-5963
Somaxon Pharmaceuticals, Inc.
CONTACT: Meg McGilley, Chief Financial Officer of Somaxon Pharmaceuticals,Inc., +1-858-509-3670; or Rob Whetstone of PondelWilkinson, Inc.,+1-310-279-5963, for Somaxon Pharmaceuticals, Inc.
Web site: http://www.somaxon.com//
