Fycompa Approved for Partial-Onset Seizures
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.
For more information call (888) 422-4743 or visit www.eisai.com.