SOMAXON PROVIDES UPDATE ON SILENOR APPLICATION

Somaxon Pharmaceuticals has announced it plans to file a new drug application (NDA) with the FDA for its insomnia drug Silenor in the third quarter of 2007. Somaxon recently completed a successful Phase III clinical program, and the FDA has informed the company that additional preclinical data may not be needed prior to NDA approval unless other preclinical data raise a concern.

In recent correspondence, the FDA agreed with Somaxon's assessment that Silenor does not appear to have genotoxic potential. The FDA also indicated that it may accept the results of a shorter-term carcinogenicity study for approval of the NDA and allow the standard two-year carcinogenicity study to be completed as a Phase IV commitment. While the company intends to discuss the subject of a shorter-term carcinogenicity study with the FDA, it believes such a study can be completed by the first half of 2008.

"We believe that this FDA communication means that we can file our NDA without carcinogenicity data and that two-year carcinogenicity studies are unlikely to be needed for approval," Ken Cohen, Somaxon's president and CEO, said.

After a planned pre-NDA meeting May 2006, the FDA had requested that Somaxon conduct additional preclinical work on Silenor. Somaxon then initiated a preclinical program consisting of standard genotoxicity, reproductive toxicology and carcinogenicity studies.

The company completed the genotoxicity studies and, in its assessment of the results, did not observe a signal indicative of genotoxicity in any of the assays. The company submitted the data from the genotoxicity studies to the FDA and, based on the company's assessment, requested that the agency clarify the required timing of submission of the data from the requested carcinogenicity studies of Silenor. The company is currently conducting the reproductive toxicology studies and plans to complete those studies in the first half of 2007.