Brivaracetam success in Phase III trial for partial onset seizures - UCB
UCB has announced positive topline results from the latest Phase III study with brivaracetam. This study was designed to evaluate the efficacy and safety of brivaracetam (100 and 200 mg/day, without titration) compared to placebo, as adjunctive treatment in adult focal Epilepsy patients with partial-onset seizures, not fully controlled despite treatment with one or two concomitant antiepileptic drugs (AEDs).
Results showed that brivaracetam reduced partial-onset seizure frequency and improved responder rates, both with statistical significance. The most commonly reported adverse events were somnolence, dizziness, fatigue and headache.
Based on the results of the brivaracetam Phase III program, UCB plans to submit a New Drug Application to the FDA and a Marketing Authorization Application to the European Medicines Agency (EMA) in early 2015.
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