Pfizer has announced positive top-line results of a study that evaluated the use of Lyrica (pregabalin) 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 of pediatric epilepsy 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 in patients with pediatric epilepsy, which was not statistically significant.
Lyrica is not approved as adjunctive therapy for pediatric epilepsy patients with partial onset seizures.
“At Pfizer we believe it is important to continue to study our medicines in relevant populations,” said Rory O’Connor, MD, Chief Medical Officer, Internal Medicine, Pfizer Inc. “Epilepsy remains a common and debilitating condition worldwide, and these results make a substantial contribution to the body of evidence for Lyrica in the pediatric population.”
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, said Pfizer in its press release.