UCB SA (UCBJF) announced positive top-line results from a phase III study (n=768) on epilepsy candidate, brivaracetam. Brivaracetam achieved a statistically significant reduction in partial-onset seizure frequency and improved responder rates in the patients compared to placebo.
In the randomized, double-blind, placebo-controlled, multi-center, parallel-group phase III study (N01358) UCB evaluated the efficacy and safety of brivaracetam, for a 12-week period, as an adjunctive treatment in patients (16 − 80 years of age) suffering from focal epilepsy with partial-onset seizures, and who have not achieved full control despite undergoing treatment with one or two concomitant antiepileptic drugs. This study was the last one scheduled under the phase III program on brivaracetam.
The phase III program comprises four studies, N01252, N01253, N01254 and N01358. In the aforementioned N01358 study, brivaracetam’s tolerability was consistent with that found in the previous studies.
Epilepsy is a chronic neurological disorder that affects nearly 65 million people across the world. According to the press release issued by UCB, almost 1 out of 26 people are expected to develop epilepsy in their lifetime.
On the basis of results from the phase III program, UCB intends to file for approval of brivaracetam in the U.S. and the EU in early 2015.
A drug already approved as an adjunctive treatment of partial-onset seizures in adults is GlaxoSmithKline (GSK)−Valeant Pharmaceuticals’ (VRX) Potiga (brand name in Europe: Trobalt).
We are encouraged by the positive phase III results on brivaracetam. We note that UCB has a strong franchise in epilepsy. The successful development and commercialization of brivaracetam will help strengthen the company’s position in the market for epilepsy products.
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