After the US Food and Drug Administration (FDA) raised issues in its Complete Response letter for the New Drug Application (NDA) for Silenor® for the treatment of insomnia, Somaxon Pharmaceuticals Inc, San Diego, met with the FDA to discuss the company’s next step.
On April 6 Somaxon met with the Division of Neurology of the FDA where the administration stated that to obtain approval of a chronic insomnia treatment, objective and subjective efficacy must be established in adult and elderly patient populations. Additionally, efficacy must be shown both at the beginning of treatment and on a persistent basis, defined as at least 1 month.
According to an announcement from the company, Somaxon now plans to conduct additional analyses of its clinical data focused on the durability of subjective sleep maintenance efficacy in adults with primary insomnia.
If Somaxon believes that its additional data analyses demonstrate that Silenor can meet the FDA’s criteria for approvability, it will include the analyses in a resubmission to the FDA. According to Somaxon, the FDA indicated that the review cycle for such resubmission would be 6 months from the date of resubmission.
Somaxon will no longer be pursuing approval of a 1 mg dose of Silenor and will not seek approval of a statement in the indication section of the label that clinical trials of Silenor have demonstrated improvements in sleep onset.
FDA Rejects Silenor Insomnia Treatment