Somaxon completes genotoxicity studies of Silenor for insomnia

By Lisa Kerner

Charlotte, N.C., Sept. 11 - Somaxon Pharmaceuticals, Inc. completed the genotoxicity studies requested by the Food and Drug Administration for Silenor (doxepin HCl) for the treatment of insomnia.

The studies included in-vitro bacterial reverse mutation test, an in-vitro mammalian chromosomal aberration test and an in-vivo rodent micronucleus test to assess for chromosomal damage.

No genotoxicity was noted in any of the assays, according to the San Diego-based pharmaceutical company.

Somaxon is also conducting reproductive toxicology studies of Silenor at the FDA's request and plans to file a New Drug Application in the third quarter of 2007.

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