FDA Approves Eisai's Oral Medication to Treat Seizures
- Wed, 10/24/12 - 11:40am
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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