Lyrica meets primary endpoint in Phase III pediatric epilepsy trial

A study that evaluated the use of the neuropathic pain drug Lyrica (pregabalin) as adjunctive therapy for pediatric epilepsy patients four to 16 years of age with partial onset seizures met its primary endpoint.

According to the drug’s maker, Pfizer (NYSE: PFE), results showed that adjunctive treatment with Lyrica 10mg/kg/day resulted in a statistically-significant reduction in seizure frequency versus placebo, the primary efficacy endpoint. Treatment with Lyrica 2.5mg/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.

“At Pfizer we believe it is important to continue to study our medicines in relevant populations,” said Rory O’Connor, chief medical officer, internal medicine, at Pfizer, adding: “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.”