Somaxon: Silenor achieves significant results in phase 3 trial as treatment for insomnia

By E. Janene Geiss

Philadelphia, April 10 - Somaxon Pharmaceuticals, Inc. announced Monday positive results from its initial phase 3 clinical trial with the tested doses of 3 mg and 6 mg of Silenor (doxepin Hcl), achieving statistically significant results in adults with chronic insomnia.

Results of the primary endpoint for this trial, eight-hour Wake After Sleep Onset. which is an objective measure of sleep maintenance using polysomnography in a sleep laboratory setting, were significant for both doses, according to a company news release.

Silenor demonstrated improvement in mean Wake After Sleep Onset of 26 minutes for 3 mg and 31 minutes for 6 mg versus a placebo for the primary analysis, officials said.

Statistical significance versus the placebo was maintained at both doses for all time points.

Improvement on Total Sleep Time was statistically significant for both doses at the initial treatment period, increasing from 374 minutes for the placebo to 415 minutes for Silenor 3 mg and 421 minutes for Silenor 6 mg, officials said.

After four weeks of nightly administration, improvement in Total Sleep Time remained statistically significant for both doses relative to the placebo, officials said.

Sleep Efficiency demonstrated results that were significant and consistent with those observed for Total Sleep Time. In the final third of the night, Silenor generally demonstrated statistically significant improvement in Sleep Efficiency versus the placebo for each dose.

Officials said both doses of Silenor were well-tolerated. Side effects were comparable to the placebo and there were no statistically significant differences versus placebo in next day residual measures.

"We are undertaking a comprehensive phase 3 program that has the potential, if successful, to establish Silenor as a first line treatment for patients with insomnia. Results from the clinical trial, coupled with the mechanism of action which is distinct from benzodiazepine and non-benzodiazepine products for insomnia, creates an opportunity for differentiation in the market," Ken Cohen, president and chief executive officer of Somaxon, said in the release.

The company said it plans to file a New Drug Application for Silenor in the first quarter of 2007.

Somaxon is a San Diego specialty pharmaceutical company focused on the fields of psychiatry and neurology.

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