Phase III results for Rikelta in Epilepsy-UCB

UCB announced the primary efficacy and safety data from the latest Phase III study evaluating Rikelta (brivaracetam) (fixed doses of 100 and 200 mg/day with no up-titration) as adjunctive treatment in adult Epilepsy patients with partial-onset seizures. This study with brivaracetam represents the largest Phase III study conducted in Epilepsy patients with partial-onset seizures and showed statistical significance for the two primary endpoints for the fixed doses. The primary efficacy endpoint in the US was the percent reduction in partial-onset seizure frequency per 28 days over placebo. The primary efficacy endpoint in the EU was the responder rate, i.e., the proportion of patients showing a 50% or greater reduction in partial-onset seizure frequency.

Both brivaracetam doses (100 and 200 mg/day) demonstrated statistically significant percent reductions in partial-onset seizure frequency per 28 days over placebo (22.8% [n=252] and 23.2% [n=249]). The 50% responder rate for brivaracetam 100 and 200 mg/day were 38.9% (98/252) and 37.8% (94/249), compared with 21.6% (56/259) for placebo. The odds ratios vs. placebo were 2.39 and 2.19 for brivaracetam 100 and 200 mg/day, respectively. The most frequent treatment-emergent adverse events were somnolence, dizziness and fatigue. Data was presented at the 68th Annual Meeting of the American Epilepsy Society.