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.
“For patients with PGTC seizures, treatment options are limited,” said Steve S. Chung, MD, of the Neuroscience Institute at the Banner University Medical Center in Phoenix, Ariz. and clinical trial investigator. “There is an unmet medical need among patients whose seizures are inadequately controlled with their current treatment and, with this indication, Fycompa may provide a new option for this group.”
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.
The most common adverse events reported in the trial in patients treated with Fycompa were dizziness, fatigue, headache, somnolence, and irritability—symptoms similar to those reported in the Phase 3 trials for partial-onset seizures.
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.