FDA Okays New Indication for Perampanel (Fycompa) in Epilepsy

Megan Brooks

June 22, 2015

The US Food and Drug Administration has expanded the indication for the antiepileptic drug (AED) perampanel hydrate (Fycompa, Eisai Inc) as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older, the company announced today.

Perampanel is a first-in-class highly selective AMPA receptor antagonist first approved in the United States as adjunctive therapy for partial-onset seizures with or without secondarily generalized seizures in patients aged 12 years and older in 2012.

The new indication for PGTC was based on results of a phase 3 study in 164 patients aged 12 years and older with PGTC seizures despite treatment with one to three AEDs. Patients received perampanel oral tablets, once daily, up to 8 mg/d in the titration period and 8 mg/d during the maintenance period.

The study showed a statistically significant reduction in PGTC seizure frequency with perampanel compared with placebo (change, –76.5% vs –38.4%; P < .0001).

In addition, significantly more children responded to perampanel than placebo (64.2% vs 39.5%; P = .0019). Roughly 31% of patients treated with perampanel were free of PGTC seizures, compared with 12% of those treated with placebo during the 13-week maintenance period.

The most common adverse events associated with perampanel were dizziness (32%), fatigue (15%), headache (12%), somnolence (11%), and irritability (11%).

Epilepsy affects approximately 2.9 million people in the United States, and roughly 30% of patients with epilepsy are unable to achieve seizure control with currently available AEDs, Eisai notes in a news release.

PGTC seizures can cause "significant injury to patients from falling down suddenly and are the most important risk factor associated with sudden unexpected death in epilepsy (SUDEP) making them one the most severe forms of epileptic seizures," the company notes. "Through this indication expansion, Fycompa can now be used as an adjunctive treatment for primary in addition to secondarily generalized tonic-clonic seizures.

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