Pfizer Inc. said its drug Lyrica failed to reduce the frequency of seizures in certain epilepsy patients during a late-stage study.
The 12-week phase 3 study was evaluating the drug against placebo as an additional therapy for epilepsy patients ages 5 to 65 years with primary generalized tonic-clonic seizures. The study was a post-marketing commitment to the U.S. Food and Drug Administration.
Epilepsy is a chronic disorder characterized by recurrent, unprovoked seizures. Primary generalized tonic-clonic seizures, formerly known as grand mal seizures, are the most common type of generalized seizures and involve loss of consciousness.
More than three million people in the U.S., including 470,000 children, are living with epilepsy, according to Pfizer's May 24 news release.
Pfizer said treatment with Lyrica did not result in a statistically significant reduction in seizure frequency versus placebo. The safety profile observed in this study was comparable to the known profile of the drug in prior epilepsy studies.
Lyrica is approved in the U.S. to treat fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles in adults. It is also approved as an additional therapy for partial onset seizures in patients four years of age and older. It is approved to treat these seizures in such patients with epilepsy who take one or more other drugs for seizures.