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Somaxon Pharmaceuticals Submits New Drug Application for SILENOR(TM) for the Treatment of Insomnia
Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for SILENOR(TM) (doxepin hydrochloride). Somaxon is seeking marketing approval of SILENOR(TM) for the treatment of insomnia.
Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the FDA is expected to determine whether to accept the NDA for filing within 60 days, and to notify the company of its determination within fourteen days thereafter. If the NDA is accepted for filing, under the PDUFA guidelines it is expected that the FDA will complete its review and provide an action letter with respect to the NDA within 10 months following submission of the NDA, or in December 2008.
"The completion and submission of our NDA for SILENOR(TM) 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, and multiple non-clinical studies. 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(TM) can be approved for the treatment of insomnia. I would like to thank the team at Somaxon, as well as the many clinicians and experts who worked with us, for their efforts in the design and conduct of the SILENOR(TM) development program and the preparation of this NDA for submission."
"Insomnia is a significant health concern in the United States. Millions of people are affected, many of whom remain undiagnosed and untreated by a physician," said Tom Roth, Ph.D., chief, division head, Sleep Disorders & Research Center, Henry Ford Hospital. "There is mounting evidence that untreated insomnia can lead to significant health consequences, including an increased risk of depression, obesity and cardiovascular disorders. If SILENOR(TM) is approved by the FDA, it has the potential to provide clinicians and patients with a unique treatment option for insomnia."
Andrew Krystal, M.D., associate professor with tenure, Duke University School of Medicine and Director, Sleep Research Laboratory and Insomnia Program, Duke University, added, "Pharmacologically, low dose doxepin, the active ingredient in SILENOR(TM), is unique. It is thought that SILENOR(TM) improves sleep by selectively blocking the wake-promoting neurotransmitter histamine, thereby decreasing the drive for wakefulness. This novel mechanism of action most likely explains the significant improvement in insomnia symptoms that was observed in controlled clinical trials without adverse effects such as amnesia, complex sleep behaviors or physical or psychological dependence."