SILENOR Data Presented at the 22nd Annual Meeting of the Associated Professional Sleep Societies
The data presented at the APSS meeting are a subset of the data from Somaxon's completed Phase 3 clinical development program, which comprised four Phase 3 clinical trials evaluating SILENOR(TM), a low-dose formulation of doxepin (1mg, 3mg and 6mg) for the treatment of insomnia. In addition to data previously presented, a new analysis shows that elderly subjects with chronic insomnia taking SILENOR(TM) experienced consistent symptom improvement beyond the traditional analyses of quantitative nighttime sleep.
"The data presented this week reiterate the value that SILENOR(TM) could deliver to physicians and the insomnia patients they treat, if it is approved by the Food and Drug Administration (FDA)," said David F. Hale, Somaxon's executive chairman and interim chief executive officer. "We believe that the new data relating to the treatment of elderly subjects with SILENOR(TM) is particularly important, as our market research indicates that the use of currently-available sleep medications by the elderly is significantly impacted by patient concerns, including those relating to addiction and side effects."
A summary of the new data presented at APSS is as follows:
Consistency of Symptom Improvement in Elderly Adults with Chronic Insomnia Treated with Doxepin 1, 3 and 6 mg (poster presentation)
Researchers completed a global symptom and severity assessment using data from two randomized, placebo-controlled Phase 3 clinical trials evaluating doxepin in elderly adults with primary insomnia. Study A was a three-month trial evaluating doxepin 1 mg and 3 mg versus placebo in 240 elderly subjects; Study B was a four-week trial evaluating doxepin 6 mg versus placebo in 255 subjects.
Symptom improvement was assessed with the two-item Clinical Global Impression scale (CGI), the five-item Patient Global Impression scale (PGI) and the Insomnia Severity Index (ISI). Doxepin 3 mg and 6 mg significantly improved the CGI-Severity and CGI-Improvement scales versus placebo at the first assessment point (Study A: Day 14, Study B: Day 7). At the end of Study A, clinicians rated insomnia symptoms one category less severe on the CGI-Severity scale for both doxepin groups compared with placebo. On the PGI, there were statistically significant improvements for doxepin 3 mg (Study A) and 6 mg (Study B) for the majority of the therapeutic effect items at each visit, and in Study A all five therapeutic effect items of the PGI were significantly improved after 12 weeks of treatment. In addition, doxepin 3 mg (Study A) and 6 mg (Study B) significantly improved the total ISI score at the first and last assessment points versus placebo.
Doxepin was well-tolerated in both studies, with side effect profiles comparable between groups, no reports of complex sleep behaviors, amnesia or anticholinergic effects and no next-day residual effects.
Previously-released data from Somaxon's Phase 3 clinical development program for SILENOR(TM) presented at the APSS 2008 annual meeting in oral presentation or poster form are as follows:
-- APSS Oral Presentation # 0701; Long-term Efficacy and Safety of Doxepin 1 mg and 3 mg in Elderly Subjects with Chronic Primary Insomnia: A presentation of the results from a three-month Phase 3 clinical trial exploring the efficacy and safety of doxepin in elderly subjects with chronic primary insomnia.
-- APSS Poster Presentation # 0784; Efficacy of Doxepin 3 mg and 6 mg on Early Awakenings in Adults with Primary Insomnia: A presentation of the effects of doxepin 3 mg and 6 mg on early morning awakening and next-day residual effects measures in a 35-day Phase 3 clinical trial in adults.
-- APSS Poster Presentation # 0783; Evaluation of Doxepin 3 mg and 6 mg in a 35-day Trial of Adults with Primary Insomnia Following Treatment Discontinuation: A presentation evaluating doxepin 3 mg and 6 mg following treatment discontinuation in a 35-day Phase 3 clinical trial of doxepin in adults.
-- APSS Poster Presentation # 0782; Efficacy and Safety of Doxepin 6 mg in a 4-week Outpatient Trial of Elderly Subjects with Primary Insomnia: A presentation of the results from a four-week Phase 3 outpatient clinical trial exploring the efficacy and safety of doxepin in elderly subjects with chronic primary insomnia.
In addition, on Monday, June 9, 2008 Somaxon sponsored an accredited CME symposium titled "Taking a Different Pathway: The Scientific Basis for the Unique Effects of Selective Antihistamines in the Treatment of Insomnia."
SILENOR(TM) is a low-dose (1 mg, 3 mg and 6 mg) oral tablet formulation of doxepin hydrochloride that is patent protected for use in insomnia. Doxepin has been prescribed for more than 35 years for the treatment of depression and anxiety at dosages typically ranging from 75 mg to 300 mg per day. At these higher doses used for these indications, doxepin is known to have a range of undesirable side effects, including anticholinergic and next-day residual effects. However, based upon the controlled clinical trials of SILENOR(TM) completed by Somaxon, the company believes that SILENOR(TM) will be well tolerated by patients. In addition, the FDA has indicated that it will recommend that SILENOR(TM) not be scheduled as a controlled substance.
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 has completed four successful Phase 3 clinical trials for its lead product candidate, SILENOR(TM) (doxepin HCl) for the treatment of insomnia. The FDA recently notified Somaxon that it accepted the NDA for SILENOR(TM) for review as of March 31, 2008. Pursuant to PDUFA guidelines, Somaxon expects that the FDA will complete its review and provide an action letter to the company with respect to the NDA by December 1, 2008.
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. For example, statements regarding the potential approval of the NDA for SILENOR(TM) and the interpretation of the results of Somaxon's clinical trials and the FDA's agreement therewith 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 potential for the FDA to impose non-clinical, clinical or other requirements to be completed before or after regulatory approval of SILENOR(TM); Somaxon's ability to demonstrate to the satisfaction of the FDA that potential NDA approval of SILENOR(TM) is appropriate without standard, long-term carcinogenicity studies, given the context of completed trials and pending studies; the potential for SILENOR(TM) to receive regulatory approval for one or more indications and with a label that is consistent with Somaxon's patent protection on a timely basis or at all; the timing and results of non-clinical studies for SILENOR(TM), and the FDA's agreement with Somaxon's interpretation of such results; the potential to enter into and the terms of any strategic transaction relating to SILENOR(TM); the scope, validity and duration of patent protection and other intellectual property rights for SILENOR(TM); Somaxon's ability to have such patent protection provide exclusivity for SILENOR(TM); Somaxon's ability to operate its business without infringing the intellectual property rights of others; unexpected findings relating to SILENOR(TM) that could delay or prevent regulatory approval or commercialization, or that could result in recalls or product liability claims; other difficulties or delays in development, testing, manufacturing and marketing of and obtaining regulatory approval for SILENOR(TM); the market potential for insomnia, and Somaxon's ability to compete; Somaxon's ability to raise sufficient capital and meet its obligations to parties it contracts with relating to financing activity, and the impact of any such financing activity on the level of Somaxon's stock price; and other risks detailed in Somaxon's prior press releases as well as in its 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 Securities Exchange Act of 1934.
Somaxon Pharmaceuticals, Inc.
Meg McGilley, Chief Financial Officer, 858-480-0402
Rob Whetstone, 310-279-5963
Manning, Selvage & Lee
Anne de Schweinitz, 212-468-3779
Posted: June 2008