Pfizer announced positive Phase 3 study data that evaluated Lyrica (pregabalin) capsules and oral solution as adjunctive therapy for pediatric epilepsy patients aged 4–16 years with partial onset seizures.
The 12-week, double-blind, placebo-controlled, randomized, parallel group, multi-center study (n=295) assessed two fixed doses of Lyrica. Study patients from 76 sites were randomized to Lyrica 2.5mg/kg daily, 10mg/kg daily, or placebo.
The results showed adjunctive treatment with Lyrica 10mg/kg daily led to a statistically significant reduction in seizure frequency compared to placebo, the study’s primary efficacy endpoint. Also, treatment with Lyrica 2.5mg/kg daily led to a numerical reduction in seizure frequency but was not statistically significant.
The safety profile among the study population was consistent with that established among adults. The study found no new safety issues or unexpected findings. Full study data will be submitted for presentation at a future scientific congress and for publication in a medical journal.
The LYRICA Pediatric Epilepsy Program consists of six studies in patients with epilepsy. Three studies have been completed and three are enrolling.
Lyrica is currently approved to treat fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain, and pain after shingles in adults. It is also approved to treat partial onset seizures in adults with epilepsy who take one or more drugs for seizures. Lyrica is available as 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, and 300mg strength capsules, and as a 20mg/mL strength solution.