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news.Eisai announced that the results of its Phase 3 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.
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Study 332 showed that FYCOMPA, when used as adjunctive therapy in the treatment of PGTC seizures in patients age 12 and older, reduced median percent in seizure frequency compared with placebo. FYCOMPA was recently FDA approved for adjunctive therapy in the treatment of PGTC seizures in patients with epilepsy age 12 and older.
Results of the Phase 3, 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% or greater reduction in PGTC seizure frequency versus 40% with placebo, which was also statistically significant.
The most frequently reported adverse events (>10% in the FYCOMPA group and greater than placebo) in patients treated with FYCOMPA in the Phase 3 clinical trial were dizziness, fatigue, headache, somnolence and irritability. The adverse event profile was similar to that noted in the controlled Phase 3 partial-onset seizure trials.
"These data showed a significant median reduction in the frequency of PGTC seizures in patients that had FYCOMPA added to their treatment regimen," said clinical trial investigator, Jacqueline French, M.D., Professor, New York University Comprehensive Epilepsy Center and Chief Science Officer, Epilepsy Foundation. "As the number of treatment options are limited for patients with PGTC seizures, FYCOMPA may provide a new option for this group."
"FYCOMPA is an in-house discovered AMPA receptor antagonist with a novel mechanism of action, providing physicians with another treatment option for patients with epilepsy age 12 and older whose PGTC seizures may not be adequately controlled with their current medication," said Lynn Kramer, M.D., FAAN, Chief Clinical Officer, President, Neuroscience & General Medicine Product Creation Unit, Eisai Product Creation Systems, Eisai Inc.
"As part of Eisai’s commitment to advancing epilepsy care, our goal is to help address unmet medical needs of epilepsy patients and their families through our corporate human health care (hhc) mission."