Pfizer’s Phase 3 Trial of LYRICA in primary generalized tonic-clonic seizures misses target

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today 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.