Eisai announced that the results of its Phase 3 trial demonstrated that Fycompa (perampanel) when used as adjunctive therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures in patients ≥12 years, reduced median percent in seizure frequency compared with placebo.
Study 332, a randomized, double-blind, placebo-controlled clinical trial of 162 patients, taking one to three antiepileptic drugs, demonstrated that patients treated with Fycompa (n=81) achieved a 76% median reduction in PGTC seizure frequency, which was statistically significant compared to 38% with placebo (n=81). Additionally, 64% of patients treated with Fycompa experienced a ≥50% reduction in PGTC seizure frequency vs. 40% with placebo, which was also statistically significant. Results of this trial have been published in the online edition of Neurology, the medical journal of the American Academy of Neurology.
Fycompa is indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures and was recently approved by the Food and Drug Administration (FDA) for adjunctive therapy in the treatment of PGTC seizures in patients with epilepsy aged ≥12. Fycompa is an oral medication and the first and only FDA-approved non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor antagonist.
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