Eisai's Fycompa for refractory partial-onset seizures meets Phase III trial primary endpoint

Japanese drug major Eisai (TYO: 4523) has announced that a Phase III trial of antiepileptic drug Fycompa (perampanel) to treat patients with refractory partial-onset seizures met its primary endpoint.

Study 335, conducted in Asia, was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the safety and efficacy of perampanel as an adjunctive therapy in 710 patients aged 12 and over with refractory partial-onset seizures.

The primary endpoint was change in seizure frequency, as measured by the percentage change in seizure frequency per 28 days during treatment, relative to baseline. Initial analysis confirmed that perampanel statistically significantly reduced seizure frequency at both 8mg/day and 12mg/day doses.