FDA issues Pfizer a Complete Response letter for Lyrica GAD monotherapy treatment

Pfizer Inc. (NYSE: PFE) announced today that the Food and Drug Administration (FDA) issued a Complete Response letter regarding the company’s New Drug Application (NDA) for Lyrica^® (pregabalin) capsules CV as a monotherapy treatment for generalized anxiety disorder (GAD). The FDA determined that the data contained 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”

“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.”