FDA accepts Somaxon’s insomnia drug NDA for filing

Acceptance of the filing means that FDA has made a threshold determination that the new drug application (NDA) is sufficiently complete to permit a substantive review. Pursuant to Prescription Drug User Fee Act guidelines, the NDA is considered filed as of March 31, 2008, and Somaxon expects that the FDA will complete its review and provide an action letter with respect to the NDA by December 1, 2008.

The NDA includes the data from Somaxon’s completed clinical development program for Silenor, which included six randomized, double-blind, placebo-controlled, multi-center clinical trials designed to assess the efficacy and safety of Silenor for the treatment of insomnia. All of the clinical trials demonstrated statistically significant differences relative to placebo on their primary endpoints and multiple secondary endpoints.

David Hale, Somaxon’s executive chairman and interim CEO, said: “While acceptance for filing of an NDA does not assure approval, we believe that the improvements in sleep onset, sleep maintenance and sleep duration and the favorable safety and tolerability profile demonstrated by our clinical development program will be sufficient to support a determination by the FDA that Silenor can be approved for the treatment of insomnia.”