UCB's brivaracetam meets in Phase III epilepsy trial

UCB Group (Euronext:UCB) said adjunctive treatment with once-daily brivaracetam for 12 weeks met the FDA-defined and EMA-defined primary endpoints vs. placebo in the Phase III N01358 trial to treat partial-onset seizures in epilepsy patients. The FDA-defined endpoint was percent reduction in partial-onset seizure frequency from baseline to day 28, and the EMA-defined endpoint was a 50% responder rate for partial-onset seizure frequency at day 28. The double-blind, international trial enrolled 768 patients with partial-onset seizures not fully controlled despite treatment with one to two concomitant antiepileptic drugs.

Early next year, UCB plans to submit an NDA to FDA and an MAA to EMA for brivaracetam as adjunctive treatment of partial-onset seizures in adult epilepsy patients. The product is a high affinity synaptic vesicle protein (SV2A) ligand. ...