San Diego-based Somaxon Pharmaceuticals' second time around with its NDA for the insomnia drug Silenor proved no more successful than the first, and its stock plunged 65 percent on the FDA's renewed objections.
The FDA issued a complete response letter for Silenor, saying that the drug did not meet the agency's standard for an approval due to "lack of robustness of sustained subjective sleep maintenance efficacy in adults with primary insomnia." Near the beginning of this year the FDA rejected Silenor because of concerns it had with the interpretation of efficacy data.
"We are disappointed in the decision because we believed that our June NDA resubmission adequately addressed the concerns raised by the FDA in its February complete response letter," said Chief Executive Richard Pascoe. He added that the company plans to schedule a sit-down with the FDA to get better insight into what needs to be done now.
- check out Somaxon's release
- here's the report from Dow Jones