The U.S. FDA this week expanded the indication of Eisai Inc.’s perampanel (Fycompa) as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures.
The additional approval comes after data from a Phase 3, randomized, double-blind, placebo-controlled trial of 162 patients showed that patients treated with Fycompa achieved a 76% median reduction in PGTC seizure frequency compared to 38% with placebo, and 64% of patients treated with Fycompa experienced a 50% or greater reduction in PGTC seizure frequency compared to 40% with placebo. All results were statistically significant.
The patients in the trial received Fycompa once daily, up to 8 mg/day, during the titration period and 8 mg/d during a 13-week maintenance period. Approximately 31% of patients treated with Fycompa were seizure free during the maintenance period compared to 12% of those treated with placebo.
Fycompa, which was approved as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures and primary generalized tonic-clonic seizures in patients 12 years and older in the U.S. in 2012, is the first and only FDA-approved non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor antagonist. Fycompa is approved in over 40 countries and currently available in 22 countries as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets.