Somaxon Submits NDA for Insomnia Drug

Somaxon Pharmaceuticals, Inc. has submitted a NDA to the FDA for Silenor for the treatment of insomnia.The FDA is expected to make a decision within 60 days. If the NDA is accepted, the FDA will complete its review and provide an action letter within 10 months following submission of the NDA, or in December 2008.
   
“The completion and submission of our NDA for Silenor represents a significant milestone for Somaxon,” said David F. Hale, Somaxon’s executive chairman and interim chief executive officer. “It is the culmination of a thorough development program that includes six well controlled clinical trials, all of which met their primary endpoints. 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 are sufficient to support a determination by the FDA that Silenor can be approved for the treatment of insomnia.”