Somaxon Scheduled To Meet FDA (NASDAQ:SOMX)

Somaxon Pharmaceuticals, Inc (NASDAQ:SOMX) has announced that they have scheduled to meet with the US Food and Drug Administration (FDA) on January 20, 2010 to discuss the New Drug Application (NDA) for Silenor which will be used for the treatment of insomnia. Silenor is a low-dose (3 mg, 6 mg) oral tablet formulation of doxepin hydrochloride which is already patent protected for use in insomnia. Many physicians have prescribed doxepin for more than 35 years for the treatment of depression and anxiety at dosages typically ranging from 75 mg to 300 mg per day. Based upon the controlled clinical trials of Silenor completed by Somaxon, the company believes that Silenor may be well tolerated by patients. In addition, the FDA has indicated that it will recommend that Silenor not be scheduled as a controlled substance.

Somaxon Pharmaceuticals, Inc. is one of the leading specialty pharmaceutical companies 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.

Last week, Somaxon disclosed that the Company has received a Complete Response Letter from the FDA in which the FDA has clearly stated that the New Drug Application for Silenor could not be approved in its present form. Hence Somaxon is seeking another way for potential approval of this NDA through focusing on alternatives that utilizes the clinical data that has been submitted to the FDA to date. Somaxon stated that they will provide with any updates regarding their discussion with the FDA about Silenor’s NDA.