Antiepileptic Gains New Adjunct Tx Indication
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.
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.