Eisai Inc. announced that a Phase 3 clinical trial (study 332) of its in-house-discovered AMPA receptor antagonist perampanel has met its primary endpoint in patients with primary generalized tonic-clonic (PGTC) seizures, a severe form of seizures.
Study 332 was a double-blind, randomized, placebo-controlled, multicenter, parallel-group trial to evaluate the efficacy and safety of adjunctive perampanel therapy in 164 patients aged 12 years and older with uncontrolled PGTC seizures receiving one to a maximum of three anti-epileptic drugs. Patients were randomized to receive perampanel or placebo in a 1:1 ratio. An analysis of the trial data demonstrates that perampanel met its primary efficacy endpoint (reduction in seizure frequency per 28 days).
The most frequently reported adverse events in this trial (>10% in the perampanel arm and greater than placebo) were dizziness, fatigue, headache, irritability and somnolence.
Based on the results of this trial, Eisai plans to submit an application to the U.S. Food and Drug Administration for an indication expansion to include the adjunctive treatment of PGTC seizures in the first half of fiscal year 2014.
Fycompa (perampanel) CIII is currently approved as an adjunctive treatment for partial-onset seizures with or without secondary generalized seizures in patients with epilepsy aged 12 years and older.
Date: June 16, 2014