Latest Ph III data for UCB’s brivaracetam presented at AES

Positive primary efficacy and safety data from the latest Phase III study evaluating Belgian drugmaker UCB‘s (Euronext Brussels: UCB) brivaracetam (fixed doses of 100 and 200mg/day with no up-titration) as adjunctive treatment in adult epilepsy patients with partial-onset seizures were presented at the 68th Annual Meeting of the American Epilepsy Society in Seattle.

This study with brivaracetam represents the largest Phase III trial conducted in epilepsy patients with partial-onset seizures. Brivaracetam is an investigational antiepileptic drug (AED) and is not approved by any regulatory authority worldwide.

This study showed statistical significance for the two primary endpoints (p<0.001 for brivaracetam 100 and 200mg/day). The primary efficacy endpoint in the USA was the percent reduction in partial-onset seizure frequency per 28 days over placebo. The primary efficacy endpoint in the European Union was the responder rate, ie, the proportion of patients showing a 50% or greater reduction in partial-onset seizure frequency. The most frequent treatment-emergent adverse events were somnolence, dizziness and fatigue.