Pftzer yesterday announced top-line results for its Phase III study for adult epilepsy drug Lyrica, which met its primary endpoint.
Lyrica, also know as pregabalin, was found to be as effective as levetiracetam, an adjunctive therapy in adult epilepsy patients experiencing refractory partial onset seizures.
The study demonstrated 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.
The Phase III study was a randomised, double-blind, parallel-group, multicentre, comparative, flexible-dose study to compare Lyrica (300mg/day, 450mg/day, 600mg/day) to levetiracetam (1,000mg/day, 2,000mg/day, 3,000mg/day) in reducing partial onset seizure frequency in subjects with epilepsy.
Study participants been diagnosed with epilepsy with partial onset seizures for at least two years, were unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs) and were on stable dosages of one or two standard AEDs.
The most common adverse events reported in Lyrica-treated patients were headache, dizziness, insomnia, somnolence, nausea and fatigue, while levetiracetam-treated patients reported similar events, but no insomnia or nausea.
Epilepsy is a chronic disorder that results in randomly occurring seizures.
Partial onset seizures, the most common type, require more than one antiepileptic medication, while refractory partial onset seizures are not completely controlled by medical treatment.
Results from the study will be submitted for presentation at upcoming scientific congresses and for publication in a peer-reviewed medical journal.