Phase III results for Fycompa (perampanel) in Epilepsy published in Neurology- Eisai

Eisai announced that the results of its Phase III trial (Study 332) for Fycompa (perampanel) CIII have been published in the online edition of Neurology, the medical journal of the American Academy of Neurology. Study 332 showed that perampanel, when used as adjunctive therapy in the treatment of primary generalised tonic-clonic (PGTC) seizures in patients age 12 and older, reduced median seizure frequency compared with placebo. Results of the randomized, double-blind, placebo-controlled clinical trial of 162 patients, taking one to three antiepileptic drugs, demonstrated that patients treated with perampanel (n=81) achieved a 77% median reduction in PGTC seizure frequency, compared to 38% reduction with placebo (n=81; p <0.0001).

Additionally, 64% of patients treated with perampanel experienced a 50% or greater reduction in PGTC seizure frequency versus 40% with placebo (p = 0.0019). The most frequently reported adverse events (>10% in the perampanel group and greater than placebo) in patients treated with perampanel in the clinical trial were dizziness, fatigue, headache, somnolence and irritability. The adverse event profile was similar to that noted in the controlled Phase III partial-onset seizure trials.