Somaxon Pharmaceuticals Submits New Drug Application For SILENOR(TM) For The Treatment Of Insomnia

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"It is the culmination of a all-embracing promotion program that include six ably controlled clinical torment, all of which meet their one-time endpoints, and multiple non-clinical den. We deem that the improvements in transport a forty winks kick-off, sleep care for and sleep duration and the favorable safekeeping and tolerability profile demonstrated by our clinical development program be an okay amount of to rouse a determination by the FDA that SILENOR™ can be certified for the managing of restlessness. I would approaching to thank the subdivision at Somaxon, in addition by method of the oodles clinicians and accustomed who work with us, for their pains in the image and conduct of the SILENOR™ development program and the scheduling of this NDA for submission." "Insomnia is a significant stamina deliberation in the United States. Millions of society are hollow, many of whom continue undiagnosed and crude by a physician," said Tom Roth, Ph.D., chief, troop commander, Sleep Disorders & Research Center, Henry Ford Hospital. "There is mounting tribute that untreated insomnia can forefront to significant Health effect, plus an increased stake of disgruntlement, size and cardiovascular anarchism. If SILENOR™ is approved by the FDA, it be supplied of the promise to provide clinicians and patients with a new treatment pull together for insomnia." Andrew Krystal, M.D., finger professor with tenure, Duke University School of Medicine and Director, Sleep Research Laboratory and Insomnia Program, Duke University, added, "Pharmacologically, dwindling dose doxepin, the cooperative item in SILENOR™, is unique. It is rumination that SILENOR™ improve sleep by selectively blocking the wake-promoting neurotransmitter histamine, thereby decreasing the drive for wakefulness. This original appliance of action maximum authentic illustrate the significant growth in insomnia symptom that be observed in controlled clinical trials undersupplied adverse effects such as amnesia, obscure sleep behaviors or labour-intensive or psychological trust." About the SILENOR™ NDA and Background of the Development Program Somaxon submit the NDA for SILENOR™ under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, which allows the company to rely next to published literature reports or the FDA's findings of safety and efficacy for other formulations of doxepin hydrochloride that have in earlier period be approved by the FDA. The NDA was submitted in accordance with the FDA's Electronic Common Technical Document (eCTD) specifications.

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