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news.Somaxon Pharmaceuticals has completed a 26-week transgenic mouse carcinogenicity study of doxepin, the active pharmaceutical ingredient in its insomnia product candidate Silenor.
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Based on the results of this study and a review of such results with its consultant toxicologists, Somaxon intends to proceed with the submission of a new drug application (NDA) for Silenor, which is now estimated to occur by mid-February 2008. As previously disclosed, based on a request from the FDA in May 2006, Somaxon has initiated a preclinical program for Silenor consisting of standard genotoxicity, reproductive toxicology and carcinogenicity studies.
David Hale, Somaxon’s executive chairman and interim CEO, said: “We are pleased to be in a position to finalize our NDA submission ahead of our projected schedule. Given the strong clinical profile of Silenor, we believe that Silenor has the potential to provide physicians and patients with a unique and clinically differentiated alternative to currently available treatments for insomnia, if the NDA is approved by the FDA.”