Eisai announced that the FDA has approved Fycompa (perampanel tablets) as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy >12 years old.
Fycompa’s approval is based on three Phase 3 studies (304, 305, and 306), which were multi-center, randomized, double-blind, placebo-controlled, dose-escalation, parallel group studies to evaluate the efficacy and safety of perampanel compared to placebo given as adjunctive therapy in patients >12 years old with partial-onset seizures. The studies demonstrated that Fycompa significantly reduced seizure frequency in patients with partial-onset seizures with or without secondarily generalized seizures.
Fycompa, a non-competitive AMPA glutamate receptor antagonist, has been recommended to be classified as a scheduled drug. Once the DEA has provided the final scheduling designation, Eisai will announce the expected launch date for Fycompa 2mg, 4mg, 6mg, 8mg, 10mg, and 12mg tablets.
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