Somaxon decides next move after FDA rejection

Somaxon has met with the FDA to decide its next steps following the rejection of its sleep drug Silenor. In February, the agency said it wouldn't approve the drug without more data, thought it didn't specifically request another trial.

In a meeting with the FDA's Division of Neurology Products, the group said Somaxon must establish objective and subjective efficacy in adult and elderly patient populations, and efficacy must be shown both at the beginning of treatment and on a persistent basis, (defined as at least one month). The good news here is that Somaxon won't have to conduct a new trial; the company will conduct additional analyses of its clinical data and include the data when it resubmits Silenor to the FDA. But the FDA has indicated that the review cycle for any such resubmission would be six months from the date of the resubmission. 

Somaxon also said it won't pursue approval of a 1 mg dose of Silenor, nor will it seek approval of a statement in the indication section of the label that clinical trials of Silenor have demonstrated improvement in sleep onset.

"We believe that our meeting with the FDA resulted in increased clarity regarding the clinical efficacy evidence necessary to support a determination by the FDA that Silenor can be approved for the treatment of insomnia," said CEO Richard Pascoe in a statement. "In addition, the FDA acknowledged receipt of our previous submission of the data from our ECG study, and no additional safety issues were raised."

- here's Somaxon's release

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