Somaxon Pharmaceuticals Inc, San Diego, provided an update on the status of its New Drug Application (NDA) for Silenor (doxepin) for the treatment of insomnia.
According to the company, Somaxon held a meeting with senior leadership at the US Food and Drug Administration (FDA) on January 20, 2010, to discuss the issues the FDA brought up in the Complete Response Letter Somaxon received in December 2009 relating to the Silenor NDA.
In the meeting, the FDA and the company discussed the remaining efficacy issue related to the robustness of sustained subjective sleep maintenance efficacy in nonelderly adults with primary insomnia.
The FDA instructed Somaxon to resubmit the contents of its January 20, 2010, premeeting briefing package to the FDA. This resubmission is 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 2-month review cycle.
No additional safety or efficacy data was required to be included in the resubmission, which the company filed on January 21, 2010.
Somaxon anticipates a decision from the FDA by March 21, 2010.
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