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news.UCB has reported that its new drug application for the use of Keppra extended- release tablets in the adjunctive treatment of partial onset seizures in adults with epilepsy, has been accepted for filing by the FDA.
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The filing for Keppra is supported by a Phase III, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of extended-release levetiracetam tablets (2x500mg) once-daily as adjunctive therapy in 158 refractory epilepsy patients, 12 to 70 years of age, with partial onset seizures.
The study met its primary endpoint for seizure reduction over placebo during the treatment period (p=0.038). The median per cent reduction of partial onset seizures in the extended-release levetiracetam group was 46.1% compared to 33.4% with placebo during the 12 week treatment period. Additionally, 24% of patients randomized to the extended-release levetiracetam group had seizure frequency per week reduced by 75-100%, compared with 11.4% of patients in the placebo group.
In the extended-release levetiracetam group 10.1% of patients had 100% reduction in partial onset seizures and 8.9% were free from any type of seizure over the treatment period, compared to 2.5% and 1.3% in the placebo group. The study also found that extended-release levetiracetam tablets were generally well tolerated.
Iris Loew-Friedrich, global head of development, UCB Group, said: “Epilepsy therapies with more convenient dosing schedules may help encourage greater patient compliance, which is important to effective seizure control.”