The US Food and Drug Administration (FDA) has approved Eisai's non-competitive AMPA glutamate receptor antagonist for patients who continue to have seizures despite being on other prescription medications for epilepsy.
The drug, FYCOMPA (perampanel), is intended for use as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy age 12 and older.
The FDA approval is based on three multi-center, randomized, double-blind, placebo-controlled, dose-escalation, parallel group Phase III studies (304, 305 and 306), designed to assess the efficacy and safety of FYCOMPA.
The studies demonstrated that FYCOMPA significantly reduced seizure frequency in patients with partial-onset seizures with or without secondarily generalized seizures.
Eisai president and chief executive officer Lonnel Coats said, "As a non-competitive AMPA glutamate receptor antagonist, FYCOMPA offers doctors and their patients a new approach towards seizure control."
In addition, the FDA has recommended the US Drug Enforcement Administration (DEA) to classify FYCOMPA as a scheduled drug under the country's Controlled Substances Act.
The company said once the DEA has provided the final scheduling designation, it will announce when FYCOMPA will be available to patients and physicians in the US.
