Phase 3 Results Announced for Lyrica as Adjunctive Therapy in Partial Onset Seizures
Pfizer announced top-line results for its Phase 3 study which showed Lyrica (pregabalin; Pfizer) capsules CV were as effective as levetiracetam as adjunctive therapy in adult epilepsy patients experiencing refractory partial onset seizures.
The study was a randomized, double-blind, parallel-group, multicenter, comparative, flexible-dose study to compare Lyrica (300, 450, 600mg/day) to levetiracetam (1,000, 2,000, 3,000mg/day) in reducing partial onset seizure frequency in patients with epilepsy. The primary efficacy endpoint was the responder rate, defined as the proportion of patients who had at least a 50% reduction in the 28 day seizure rate (all partial seizures) during the 12-week maintenance phase, as measured from the 6-week baseline.
The primary endpoint was met for this study by demonstrating that a comparable proportion of patients on Lyrica achieved at least a 50% reduction in the 28-day seizure rate during the maintenance phase relative to levetiracetam.
Lyrica has been approved for partial onset seizures in adults with epilepsy who take one or more drugs for seizures, management of fibromyalgia, neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia (pain after shingles), and the management of neuropathic pain associated with spinal cord injury.For more information call (800) 438-1985 or visit www.lyrica.com