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GEN News Highlights : Aug 25, 2010

Eisai’s Epilepsy Therapy Meets Goals in First of Three Phase III Trials

Perampanel decreased median seizure frequency and improved responder rates.

Eisai reported positive results of a Phase III study with perampanel (E2007) for the treatment of partial seizures in patients with epilepsy. The compound is a highly selective noncompetitive AMPA-type glutamate receptor antagonist.

The double-blind, placebo-controlled, parallel-group study (study 306) showed that perampanel was effective in reducing median seizure frequency and increasing responder rates, the primary outcome measures in the U.S. and EU, 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 drug was well tolerated, and the most common adverse events reported were dizziness, somnolence, and headache.

Study 306 is the first trial in Eisai’s Phase III development program for perampanel. Two more global Phase III studies are under way, and results are expected to be available within one year. Eisai intends to simultaneously submit in the U.S. and EU in the fiscal year 2011, which for the firm is the year ending March 31, 2012.