Somaxon's Silenor helps insomnia patients fall asleep faster, study says

By Lisa Kerner

Charlotte, N.C., Oct. 23 - Somaxon Pharmaceuticals, Inc. president and chief executive officer Ken Cohen said he is "extremely pleased" with the positive results from the phase 3 clinical trial of Silenor, a low-dose (1 mg, 3 mg, 6 mg) oral tablet formulation of doxepin HCl.

Results demonstrated that 6 mg of Silenor was well tolerated and was effective at inducing sleep and maintaining sleep throughout the night in the study of 565 adults with transient insomnia.

In the phase 3, randomized, double-blind study, Silenor demonstrated statistically significant improvements compared to a placebo in the trial's primary endpoint, time to persistent sleep. Efficacy assessments evaluated both objective polysomnography and subjective measures of sleep.

Results showed a statistically significant improvement of time to persistent sleep of 13 minutes and an improvement in time to sleep onset of 16 minutes compared with placebo, according to a company news release.

In other endpoints, Silenor demonstrated a 40-minute improvement in wake after sleep onset and a 51-minute improvement in total sleep time versus placebo.

Silenor also showed statistically significant results compared with placebo in subjective measures of sleep maintenance and sleep quality.

As a result of completed phase 2 and phase 3 studies of Silenor in adults and elderly patients with chronic insomnia and transient insomnia, Somaxon said it expects to file a New Drug Application in the third quarter of 2007.

Somaxon believes Silenor can become the first non-scheduled insomnia treatment to help patients fall asleep and maintain sleep throughout the night, according to Cohen. The transient insomnia indication is especially important because the company's patent covering the use of Silenor in patients with transient insomnia extends until 2020.

"We are building evidence of an attractive product profile," Cohen said.

Results from two phase 3 clinical trials of Silenor are expected by the end of the year, including a three-month trial and a four-week outpatient trial in elderly patients.

Somaxon is a San Diego-based specialty pharmaceutical company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.