Somaxon Pharmaceuticals to meet FDA to discuss the NDA for Silenor for insomnia treatment

Dec 18 2009

Somaxon Pharmaceuticals, Inc. (Nasdaq:SOMX), a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today stated that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the New Drug Application (NDA) for Silenor^® (doxepin) for the treatment of insomnia.

As Somaxon previously disclosed, on December 4, 2009 the company received a Complete Response Letter from the FDA in which the FDA stated that the NDA could not be approved in its present form. Somaxon previously received a Complete Response Letter for the NDA in February 2009, and it resubmitted the NDA in June 2009. Somaxon is seeking a pathway for potential approval of the NDA, focusing on alternatives that utilize the clinical data that has been submitted to the FDA to date.

Somaxon will provide an update regarding its discussions with the FDA relating to the Silenor NDA promptly after the company has analyzed the feedback it receives at the meeting.