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FDA Expands Labeling for Antiepileptic Agent Fycompa (Perampanel) to Include Adjunctive Treatment of Tonic-Clonic Seizures

Phase III study finds 64% responder rate

The FDA has expanded the indication for the antiepileptic drug Fycompa (perampanel hydrate, Eisai) to include its use as an adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients 12 years of age and older with epilepsy.

The agency’s decision was based on data from a phase III placebo-controlled trial of perampanel in 164 patients aged 12 years and older with PGTC seizures. In the study, a statistically significant reduction in the frequency of PGTC seizures was observed in the perampanel group compared with the placebo group (–76.5% vs. –38.4%, respectively; P < 0.0001). In addition, the responder rate for perampanel was 64.2%, which was a statistically significant improvement over the responder rate of 39.5% for placebo (P = 0.0019). Further, 30.9% of patients treated with perampanel were free of PGTC seizures (compared with 12.3% of placebo-treated patients) during the 13-week maintenance period.

The most common adverse events associated with perampanel included dizziness, fatigue, headache, somnolence, and irritability.

Perampanel is a selective, noncompetitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor antagonist that reduces the neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. Fycompa (perampanel) was approved by the FDA as an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients 12 years of age and older with epilepsy in October 2012 and was launched in January 2014.

Generalized tonic-clonic seizures can cause significant injury to patients from sudden falls and are the most important risk factor associated with sudden unexpected death in epilepsy, making them one the most severe forms of epileptic seizures.

Epilepsy affects approximately 2.9 million people in the U.S. Approximately 30% of patients with epilepsy are unable to control their seizures with currently available antiepileptic drugs.

Source: Eisai; June 22, 2015.

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