Somaxon Provides Update On New Drug Application For Silenor R For The Treatment Of Insomnia
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Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), 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, today provided an update on the status of its New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.
Somaxon held a meeting with senior leadership at the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the issues raised by the FDA in the Complete Response Letter Somaxon received in December 2009 relating to the Silenor NDA. The only remaining efficacy issue was related to the robustness of sustained subjective sleep maintenance efficacy in non-elderly adults with primary insomnia. In the meeting, the FDA and the company discussed this issue, and the agency instructed Somaxon to resubmit the contents of its January 20, 2010 pre-meeting briefing package to the FDA. The agency acknowledged that this resubmission would be considered a complete response to the Complete Response Letter Somaxon received in December. The FDA also agreed that this would be considered a Class 1 resubmission with a two-month review cycle. No additional safety or efficacy data was required to be included in the resubmission, and the company filed the resubmission with the FDA on January 21, 2010. As a result, the company anticipates a decision from the FDA by March 21, 2010.
"We believe that the dialogue we had with the FDA was constructive," said Richard W. Pascoe, Somaxon's president and chief executive officer. "We intend to continue to work diligently with the FDA during the two-month review cycle toward a potential approval for Silenor."
In the meeting the FDA also reiterated that a revised Risk Evaluation and Mitigation Strategy (REMS), including a Medication Guide to be distributed with the product, will be required.
Silenor is a low-dose (3 mg, 6 mg) oral tablet formulation of doxepin hydrochloride that is patent protected for use in insomnia. Physicians have prescribed doxepin for more than 35 years for the treatment of depression and anxiety at dosages typically ranging from 75 mg to 300 mg per day. Based upon the controlled clinical trials of Silenor completed by Somaxon, the company believes that Silenor may be well tolerated by patients. In addition, the FDA has indicated that it will recommend that Silenor not be scheduled as a controlled substance.
Somaxon Pharmaceuticals, Inc.
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