Insomnia is most often defined by an individual's report of sleeping difficulties. While the term is sometimes used in sleep literature to describe a disorder demonstrated by polysomnographic evidence of disturbed sleep. Thus, insomnia is most often thought of as both a sign and a symptom that can accompany several sleep, medical, and psychiatric disorders, characterized by persistent difficulty falling asleep and/or staying asleep or sleep of poor quality. Insomnia is typically followed by functional impairment while awake.
Somaxon Pharmaceuticals, Inc. (NASDAQ:SOMX)yesterday announced that it recently had a meeting with the U.S. Food & Drug Administration (FDA) relating to the over-the-counter (OTC) development program for Silenor®. In the meeting, which Somaxon Pharmaceuticals attended jointly with its Silenor partner Procter & Gamble, the FDA provided clinical and regulatory guidance that Somaxon Pharmaceuticals believes provides a clear path forward toward an OTC version of Silenor. Somaxon Pharmaceuticals believes that the FDA's guidance provides an opportunity to develop an OTC label that is tailored to Silenor's clinical profile and differentiated from other OTC sleep products. Somaxon Pharmaceuticals believes that Silenor's characteristics, including its lack of addiction potential and its clinical efficacy and safety profile, make it an ideal candidate to be the first prescription insomnia product to be converted to an OTC product.
Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded products and late-stage product candidates to treat important medical conditions where there is an unmet medical need and/or high-level of patient dissatisfaction, currently in the central nervous system therapeutic area. The product Silenor from Somaxon Pharmaceuticals, now available by prescription in the United States, is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.
For more information about Somaxon Pharmaceuticals, please visit www.somaxon.com
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