Antiepileptic Gains New Adjunct Tx Indication

Antiepileptic Gains New Adjunct Tx Indication
Antiepileptic Gains New Adjunct Tx Indication

Eisai announced that the Food and Drug Administration (FDA) has approved Fycompa (perampanel) as adjunctive therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures.

The FDA approval was supported by data from Study 332, a Phase 3, randomized, double-blind, placebo-controlled clinical trial (n=162) that evaluated the safety and efficacy of Fycompa as adjunctive therapy for PGTC seizures in patients taking 1–3 antiepileptics. The study showed that Fycompa-treated patients achieved a 76% median reduction in PGTC seizure frequency vs. 38% in the placebo group. Further, 64% of Fycompa-treated patients experienced a ≥50% reduction in PGTC seizure frequency vs. 40% in the placebo group.

RELATED: Fycompa sNDA Under Review for Primary Generalized Tonic-Clonic Seizures

Fycompa, an AMPA glutamate receptor antagonist, is a CIII controlled substance already approved as adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients ≥12 years of age.

Fycompa is available as 2mg, 4mg, 6mg, 8mg, 10mg, and 12mg strength tablets in 30- and 90-count bottles.

For more information call (888) 422-4743 or visit Fycompa.com.