Eisai reports positive Ph III results for perampanel in partial epilepsy

Japan's fourth largest drugmaker Eisai (TYO: 4523) has announced encouraging results of a Phase III study for the investigational compound perampanel (E2007), a first-in-class, highly selective non-competitive AMPA-type glutamate receptor antagonist, discovered by Eisai and under development for adjunctive 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 versus placebo, the primary outcome measures in the USA and the European Union, respectively. The findings were 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. The most common adverse events reported were dizziness, somnolence and headache.