Pfizer says LYRICA phase 3 trial in pediatric epilepsy meets primary endpoint
Pfizer announced positive top-line results of a study that evaluated the use of LYRICA Capsules CV and Oral Solution CV as adjunctive therapy for pediatric epilepsy patients four to 16 years of age with partial onset seizures. Results showed that adjunctive treatment with LYRICA 10 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo, the primary efficacy endpoint. Treatment with LYRICA 2.5 mg/kg/day resulted in a numerical reduction in seizure frequency, which was not statistically significant. LYRICA is not approved as adjunctive therapy for pediatric epilepsy patients with partial onset seizures. The LYRICA Pediatric Epilepsy Program is composed of a total of six studies in patients with epilepsy evaluating LYRICA as adjunctive therapy, three of which have been completed and three are actively enrolling.