Somaxon to file Silenor in third quarter

Somaxon also said that the FDA agreed that Silenor does not appear to cause cancer or induce genetic mutations and therefore assessment of these side effects would not be required for approval unless more data suggests otherwise.

At a previous meeting with Somaxon, the FDA requested that additional preclinical work be conducted regarding Silenor and be included in the original new drug application. Somaxon then initiated a preclinical program consisting of standard genotoxicity, reproductive toxicology and carcinogenicity studies.

The FDA also indicated to Somaxon that depending on the outcome of the genotoxicity studies, it may be flexible as to the timing of the conduct of the carcinogenicity studies, including the potential that the data from those studies may be submitted as a post-approval commitment.

In the study there was not a signal indicative of genotoxicity in any of the assays. Somaxon has now 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 of Silenor requested by the FDA and plans to complete those studies in the first half of 2007.