UCB’s antiepileptic drug found effective in Phase III trial

The study met its primary endpoint for seizure reduction over placebo during the treatment period (p=0.038). The median percent 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 to 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, respectively. The study also found that extended-release levetiracetam tablets were generally well tolerated.

The Phase III, multicenter, randomized, double-blind, placebo-controlled study evaluated efficacy, safety, and tolerability of extended-release levetiracetam tablets (2×500 mg) once-daily as adjunctive therapy in 158 refractory epilepsy patients, 12 to 70 years of age, with partial onset seizures.

UCB is in the process of submitting a new drug application for the use of Keppra XR in the adjunctive treatment of partial onset seizures in adults with epilepsy to the FDA.

Iris Loew-Friedrich, global head of development, UCB, said: “These data show that the once-daily, extended-release formulation of Keppra reduced the frequency of partial onset seizures in patients with uncontrolled epilepsy and was generally well tolerated.”