Pfizer Gets Complete Response Letter for Lyrica GAD Monotherapy

Pfizer received a Complete Response letter from the FDA regarding its NDA for Lyrica (pregabalin) capsules CV as a monotherapy treatment for generalized anxiety disorder (GAD). The FDA determined that the data in the NDA were insufficient to support approval. The application was a resubmission in response to a “not-approvable” letter issued by the FDA in August 2004. The FDA continues to review a separate application for Lyrica as adjunctive therapy for the treatment of GAD.

“We are disappointed with the FDA’s decision and will work with the agency to determine next steps,” said Steve Romano, vice president, Medical Affairs Head, Primary Care Business Unit. “Given the chronic nature of GAD and the number of patients who continue to experience anxiety symptoms despite treatment, there is a clear unmet need for new and different treatment options.”