Eisai Announces Positive Phase III Trial Results for Perampanel in Partial Epilepsy
Eisai announced 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 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 U.S. and the E.U., respectively. The findings were 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 for adjunctive therapy in partial seizures 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 U.S. and E.U. in our Fiscal Year 2011.
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