Health & Fitness
Health and Fitness
Health and Fitness
Wed, September 8, 2010
Tue, September 7, 2010
Somaxon Pharmaceuticals Announces Commercial Availability of Silenor
SAN DIEGO--([ BUSINESS WIRE ])--Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company, today announced that Silenor® (doxepin) now is commercially available by prescription in the United States. Somaxon has implemented a wholesale and retail stocking program to disseminate Silenor 3 mg and 6 mg dosepacks to pharmacies across the United States. Silenor is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.
"We look forward to promoting this highly differentiated product to healthcare providers alongside our co-promotion partner, Procter & Gamble. Our combined sales teams will begin full-scale, field-based promotion of the product on September 20, 2010, targeting approximately 35,000 physicians and 25,000 pharmacies across the U.S."
aThe commercial availability of Silenor, the first and only prescription product approved for the treatment of sleep maintenance insomnia that is not a controlled substance, is an important milestone for Somaxon and marks the completion of our product launch preparations,a said Richard W. Pascoe, Somaxona™s President and Chief Executive Officer. aWe look forward to promoting this highly differentiated product to healthcare providers alongside our co-promotion partner, Procter & Gamble. Our combined sales teams will begin full-scale, field-based promotion of the product on September 20, 2010, targeting approximately 35,000 physicians and 25,000 pharmacies across the U.S.a
aIn conjunction with the deployment of our field-based promotion to healthcare providers, we will launch a comprehensive marketing program that will utilize web-based initiatives and will be directed at both physicians not called on directly by our sales force as well as patients suffering from sleep maintenance insomnia,a continued Pascoe. aThis campaign will highlight the traits that we believe will position Silenor for success in the insomnia market a" the ability to treat sleep maintenance insomnia into the final hours of the night without meaningful next-day residual effects and without abuse potential.a
About Silenor®
Silenor is a low-dose (3 mg, 6 mg) oral tablet formulation of doxepin that is patent protected for use in insomnia. The Silenor NDA was approved in March 2010 for the treatment of insomnia characterized by difficulties with sleep maintenance. The NDA included all of the data from the companya™s development program, including data from Somaxona™s clinical trial program that evaluated 1,017 subjects exposed to Silenor from 12 studies.
Important Safety Information
A doctor should be consulted if insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing the sleep problem.
Patients should be sure that they are able to devote 7 to 8 hours to sleep before being active again. Silenor should be taken within 30 minutes of bedtime. Patients should not take Silenor with alcohol or with other medicines that can cause drowsiness. Silenor should not be taken with or within two weeks after taking a monoamine oxidase inhibitor (MAOI). Patients should not take Silenor if they have untreated narrow angle glaucoma, if they have severe urinary retention, if they have severe sleep apnea or if they are allergic to any of the ingredients in Silenor. Until patients know how they will react to Silenor, they should not drive or operate machinery at night after taking Silenor, and they should be careful in performing such activities during the day following taking Silenor. Before taking Silenor, patients should tell their doctors if they have a history of depression, mental illness or suicidal thoughts. Patients should call their doctors right away if after taking Silenor they walk, drive, eat or engage in other activities while asleep. Drowsiness was the most common adverse event observed in clinical trials.
For more information, please see the complete Prescribing Information, including the Medication Guide, at [ www.silenor.com ] or [ www.somaxon.com ].
About Somaxon Pharmaceuticals, Inc.
Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is 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. Somaxona™s product Silenor® (doxepin) has been approved by the FDA for the treatment of insomnia characterized by difficulty with sleep maintenance.
For more information, please visit the companya™s web site at [ www.somaxon.com ].
Somaxon cautions readers that statements included in this press release that are not a description of historical facts are forward-looking statements.For example, statements regarding the commercial availability of Silenor and Somaxona™s sales and marketing plans are forward-looking statements.The inclusion of forward-looking statements should not be regarded as a representation by Somaxon that any of its plans will be achieved.Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Somaxona™s business, including, without limitation, Somaxona™s ability to successfully commercialize Silenor; Somaxona™s reliance on its co-promotion partner, Procter & Gamble, and its contract sales force provider, Publicis, for critical aspects of the commercial sales process for Silenor; the performance of Procter & Gamble and Publicis and their adherence to the terms of their contracts with Somaxon; the ability of Somaxona™s sales management personnel to effectively manage the sales representatives employed by Publicis; the ability of Somaxon to ensure adequate and continued supply of Silenor to successfully launch commercial sales or meet anticipated market demand; the scope, validity and duration of patent protection and other intellectual property rights for Silenor; whether the approved label for Silenor is sufficiently consistent with such patent protection to provide exclusivity for Silenor; Somaxona™s ability to operate its business without infringing the intellectual property rights of others; the market potential for insomnia treatments, and Somaxona™s ability to compete within that market; inadequate therapeutic efficacy or unexpected adverse side effects relating to Silenor that could delay or prevent commercialization, or that could result in recalls or product liability claims; other difficulties or delays in development, testing, manufacturing and marketing of Silenor; the timing and results of post-approval regulatory requirements for Silenor, and the FDAa™s agreement with Somaxona™s interpretation of such results; Somaxona™s ability to raise sufficient capital to fund its operations, and the impact of any such financing activity on the level of its stock price; the impact of any inability to raise sufficient capital to fund ongoing operations; and other risks detailed in Somaxona™s prior press releases as well as in its periodic filings with the Securities and Exchange Commission.
Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.All forward-looking statements are qualified in their entirety by this cautionary statement, and Somaxon undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.This caution is made under the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934.
