Eisai's Phase III trial of Perampanel for epilepsy shows positive results

Aug 25 2010

Eisai Inc. announced today the 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 being developed for 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 4 mg and 8 mg 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 2 mg doses of perampanel, then remained on 2 mg or increased dosage weekly in 2 mg increments to their randomized doses of 4 mg or 8 mg. The most common adverse events reported were dizziness, somnolence and headache.

Study 306 is the first in a series of Phase III clinical trials as part of Eisai's development program for perampanel and two more global Phase III studies are underway. Eisai plans to submit the studies as part of global applications, and results are expected to be available within one year.

As previously announced, Eisai intends to submit simultaneously in the United States and European Union in our Fiscal Year 2011 (year ending March 31, 2012).

Source: Eisai Inc.