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Somaxon Pharmaceuticals Announces Presentation Of Silenor® Data At National Medical Meetings

Stocks in this article: SOMX

Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX), a specialty pharmaceutical company, today announced that it will present new analyses of data from the Silenor Phase 3 clinical development program at the American Psychiatric Association (APA) 164 th Annual Meeting, the Associated Professional Sleep Societies (APSS) 25 th Annual Meeting and the American Academy of Nurse Practitioners (AANP) 26 th National Conference.

“We are excited to be presenting these new analyses of Silenor data at these important medical meetings. By examining specific patient groups and patient-reported outcomes in our pivotal clinical trials, we hope to provide the medical community with further support for Silenor’s utility in the treatment of insomnia characterized by difficulties with sleep maintenance,” said Brian T. Dorsey, Somaxon’s Senior Vice President, Technical Operations.

A summary of the data presentations is as follows:

Somaxon’s Poster Presentations at APA in Honolulu, HI, on Tuesday, May 17 th

  • APA Poster Presentation # NR10-45; Improvement in Sleep Maintenance and Early Morning Awakenings in Adult and Elderly Patients with Insomnia Treated with Doxepin 3 and 6 mg
  • APA Poster Presentation # NR10-42; Patient-Reported Symptom Improvement in Sleep Maintenance Endpoints in Adult and Elderly Patients with Insomnia Treated with Doxepin 3 and 6 mg

Somaxon’s Poster Presentation at APSS in Minneapolis, MN, on Monday, June 13 th

  • APSS Poster Presentation # 198; Improvement in Sleep Maintenance and Early Morning Awakenings in Adult and Elderly Patients with Insomnia Treated with Doxepin 3 and 6 mg

Somaxon’s Oral Presentation at APSS in Minneapolis, MN, on Wednesday, June 15 th

  • APSS Abstract # 1051955: Session 039; Patient-Reported Symptom Improvement in Sleep Maintenance Endpoints in Adult and Elderly Patients with Insomnia Treated with Doxepin 3 and 6 mg

Somaxon’s Poster Presentations at AANP in Las Vegas, NV, June 22 nd – 26 th

  • AANP Poster Presentation; Improvement in Sleep Maintenance and Early Morning Awakenings in Adult and Elderly Patients with Insomnia Treated with Doxepin 3 and 6 mg
  • AANP Poster Presentation; Patient-Reported Symptom Improvement in Sleep Maintenance Endpoints in Adult and Elderly Patients with Insomnia Treated with Doxepin 3 and 6 mg
  • AANP Poster Presentation; Results from Clinical Trials Using Low-Dose Doxepin: Treatment Responders Defined by Categorical Criteria

About the Silenor Data

  • Improvement in Sleep Maintenance and Early Morning Awakenings in Adult and Elderly Patients with Insomnia Treated with Doxepin 3 and 6 mg : Silenor 3 mg and 6 mg demonstrated significant improvements in wake after sleep onset (WASO), subjective wake after sleep onset (sWASO) and sleep efficiency in the last quarter of the night (SE-LQ) that were consistent across four Phase 3 clinical trials and maintained at the final time point for all but one assessment. Across the clinical trials, these effects were not accompanied by clinically significant next day residual effects, and the dosages of Silenor were well-tolerated. These data suggest Silenor is effective and well tolerated for the treatment of both sleep maintenance (WASO and sWASO) and early morning awakenings (SE-LQ) in transient and chronic insomnia populations.
  • Patient-Reported Symptom Improvement in Sleep Maintenance Endpoints in Adult and Elderly Patients with Insomnia Treated with Doxepin 3 and 6 mg: Across two Phase 3 clinical trials measuring subjective endpoints of sleep maintenance, Silenor 3 mg and 6 mg in adult patients and 3 mg in elderly patients achieved significant improvements that were sustained (up to three months) compared with placebo, in subjective wake after sleep onset (sWASO) and total sleep time (sTST). In both clinical trials, these effects were not accompanied by clinically significant next day residual effects and the dosages of Silenor were well-tolerated. These data suggest Silenor is effective and well tolerated for the treatment of insomnia characterized by sleep maintenance in both adult and elderly populations.
  • Results from Clinical Trials Using Low-Dose Doxepin: Treatment Responders Defined by Categorical Criteria: An analysis of three Phase 3 clinical trials (two in adults and one in the elderly) demonstrated that Silenor treatment resulted in substantial increases in the percentage of subjects responding to treatment relative to placebo.

About Silenor®

Silenor is a low-dose (3 mg and 6 mg) oral tablet formulation of doxepin, and is the first and only non-scheduled prescription sleep medication approved to treat insomnia characterized by difficulties with sleep maintenance. Sleep maintenance is defined as waking frequently during the night and/or waking too early and being unable to return to sleep. For more information, please visit www.silenor.com.

Important Safety Information

A doctor should be consulted if insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing the sleep problem.

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