Eisai announced results from its Phase 3 study of perampanel for the treatment of partial seizures in patients with epilepsy. The double-blind, placebo-controlled, parallel-group study (Study 306) showed that perampanel was well-tolerated and effective in reducing median seizure frequency and increasing responder rates, the primary outcome measures in the United States and European Union, respectively. The findings were highly statistically significant in 4mg and 8mg doses compared to placebo. A linear trend for dose response was also statistically significant.
The global study consisted of 706 patients from 25 countries who were randomized to placebo or one of three perampanel doses. Patients started on 2mg doses of perampanel, then remained on 2mg or increased dosage weekly in 2mg increments to their randomized doses of 4mg or 8mg.
Perampanel is a first-in-class, highly selective non-competitive AMPA-type glutamate receptor antagonist.
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