Pfizer epilepsy drug Lyrica fails in phase III trial
New Delhi: Pfizer Inc. recently 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 (USFDA).
In the U.S., LYRICA is indicated to treat fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles in adults and is approved as adjunctive therapy for the treatment of partial onset seizures in patients four years of age and older.
It is also indicated to treat partial onset seizures in patients 4 years of age and older with epilepsy who take 1 or more other drugs for seizures.
"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," Juan added.
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.
LYRICA is currently approved for various indications in more than 130 countries and regions globally.
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