New Product
Somaxon Pharmaceuticals Announces Commercial Availability of Silenor
By
Sep 7, 2010 - 9:42:03 AM

(HealthNewsDigest.com) - SAN DIEGO --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.

“The 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,” said Richard W. Pascoe, Somaxon’s President and Chief Executive Officer. “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.”

“In 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,” continued Pascoe. “This campaign will highlight the traits that we believe will position Silenor for success in the insomnia market – the ability to treat sleep maintenance insomnia into the final hours of the night without meaningful next-day residual effects and without abuse potential.”

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 company’s development program, including data from Somaxon’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.comor 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. Somaxon’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 company’s web site at www.somaxon.com.

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