Pfizer announces Phase III study of Lyrica for patients with pediatric epilepsy.

Pfizer Inc. announced positive top-line results of a Phase III study examining the use of Lyrica (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age.

Results showed that adjunctive treatment with Lyrica 14 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo, the primary efficacy endpoint. Treatment with Lyrica at the lower dose (7 mg/kg/day) did not result in a statistically significant reduction in seizure frequency versus placebo. The study was a post-marketing requirement by the FDA. Lyrica is not approved as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age. The Lyrica Pediatric Epilepsy Program is composed of a total of six studies in patients with epilepsy evaluating Lyrica as adjunctive therapy, four of which have been completed and two of which are actively enrolling.