Cath Lab Digest

The FDA approved Fycompa^® (perampanel), a non-competitive AMPA-type glutamate receptor antagonist to treat patients with epilepsy. The oral medication, manufactured by Eisai, Inc., is intended to treat partial-onset seizures with or without secondarily generalized seizures.

Eisai has two other FDA-approved drugs to treat epilepsy: Zonegran^® (zonisamide) and Banzel^® (rufinamide).

In July 2011, the FDA rejected perampanel's submission and requested a re-analysis of data. This week's approval was based on three phase 3, randomized, double-blind, placebo-controlled studies that included 1480 patients who had partial-onset seizures.

Patients who took perampanel as an adjunctive therapy had a significant reduction in seizure frequency compared to a placebo group. Common adverse reactions included dizziness, drowsiness, fatigue, irritability, upper respiratory tract infection, weight increase, and vertigo.

The drug's label contains a Boxed Warning that alerts prescribers and patients of the risk of serious neuropsychiatric events, which can be potentially serious and life-threatening.

The FDA's news release is available here

Eisai's news release is available here

-Tim Casey