FDA Issues Complete Response Letter To Pfizer For Lyrica

The FDA has issued a complete response letter regarding Pfizer’s New Drug Application (NDA) for Lyrica (pregabalin) capsules CV, as a monotherapy treatment for generalised anxiety disorder (GAD).

Lyrica is used to control seizures and to treat fibromyalgia. It is also used to treat pain caused by nerve damage in people with diabetes (diabetic neuropathy) or herpes zoster (post-herpetic neuralgia).

The FDA has 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.

Steve Romano, vice president of medical affairs, and head of primary care business unit at Pfizer, said: “We are disappointed with the FDA’s decision and will work with the agency to determine next steps. 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.”