Somaxon Pharmaceuticals said today that it has resubmitted data for its sleep drug Silenor to the FDA, making it the company's third go-around with the agency. The drug was first rejected in early 2009, when the FDA said it couldn't approve the sleep therapy without more data, though the agency didn't call for a new trial. Somaxon regrouped and resubmitted, but was once again dealt a blow when the FDA rejected the drug a second time. The agency refused to approve Silenor due to a "lack of robustness of sustained subjective sleep maintenance efficacy in adults with primary insomnia."
Somaxon met with the FDA once again to discuss the drug's future. The good news? No additional safety or efficacy data was required to be included in the third resubmission, which was filed yesterday. The FDA's primary concern is still the strength of the company's data for sustained subjective sleep maintenance efficacy in non-elderly adults with primary insomnia. Somaxon was instructed to resubmit the contents of its January 20, 2010 pre-meeting briefing package. The agency also reiterated that a revised Risk Evaluation and Mitigation Strategy, including a Medication Guide to be distributed with the product, will be required. A decision is expected by March 21.
- take a look at Somaxon's release
- here's the Reuters report for more