Monday, December 7, 2009
Somaxon Gets Rejection From FDA
San Diego-based Somaxon Pharmaceuticals, a developer of a drug for the treatment of insomnia, reported this morning that it has received a response from the U.S. Food and Drug Administration on its NAD for Silenor, the firm's treatment of insomnia. The firm said that the Complete Response Letter from the FDA said that based on its review, the FDA has determined that Somaxon's NDA cannot be approved in its present form. The rejection is the second for Somaxon on its NDA, which also saw a similar response from the FDA in February. Somaxon said the FDA said that its NDA "did not meet the approval standard for efficacy", although there were no clinical safety issues raised. Somaxon said it believes a meeting with the FDA will be necessary to get guidance from the FDA on its decision.