Published on December 18, 2009 at 12:41 AM
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.
http://www.somaxon.com/