Pfizer Announces Top-Line Results from Phase 3 Trial of LYRICA (pregabalin) in Primary Generalized Tonic-Clonic Seizures

Pfizer Inc. announced that a Phase 3 study to assess the use of LYRICA (pregabalin) as adjunctive therapy for epilepsy patients 5 to 65 years of age with primary generalized tonic-clonic (PGTC) seizures did not meet its primary endpoint. Treatment with LYRICA did not result in a statistically significant reduction in seizure frequency versus placebo. Lyrica is not indicated in any population for the treatment of PGTC seizures. The study was a post-marketing commitment to the U.S. Food and Drug Administration (FDA).

“Pfizer is committed to the study of patient populations with unmet treatment needs, including pediatric and adult patients experiencing generalized tonic-clonic seizures,” said Juan Ovalle, M.D., Global Chief Medical Officer, R&D and Medical, Upjohn, a division of Pfizer. “These data contribute to our growing understanding of pediatric epilepsy and reflect our responsibility to advance scientific knowledge through post-marketing research.”

The LYRICA Pediatric Epilepsy Program is composed of six studies in patients with epilepsy evaluating LYRICA as adjunctive therapy, five of which have been completed.