US FDA calls for more data on Pfizer's Lyrica for generalized anxiety disorder; sells drug rights to TMC

The US Food and Drug Administration has issued a Complete Response letter regarding global drugs behemoth Pfizer's New Drug Application for Lyrica (pregabalin) 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.

'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,' he noted.