July 21, 2006 Based on a request from the Food and Drug Administration (FDA), Somaxon Pharmaceuticals, San Diego, is updating information regarding the preclinical testing of SILENOR™ (doxepin HCl), a drug candidate for the treatment of insomnia. The preclinical program that Somaxon has initiated included studies involving genotoxicity, reproductive toxicology, and carcinogenicity. Unexpectedly for Somaxon, the FDA has requested that data from the genotoxicity studies and reproductive toxicology studies of SILENOR should be included in the original New Drug Application (NDA), leading the company to anticipate that an NDA submission for SILENOR could happen in the third quarter of 2007. According to a Somaxon release, "The company believes that the FDA's request was not in response to any specific safety concern arising from ongoing or completed SILENOR™ clinical trials." SILENOR is currently in Phase III clinical trials.