Epileptic Seizure Treatment Use Expanded by FDA

June 22, 2015
Meghan Ross, Associate Editor

The FDA today expanded the indication for perampanel hydrate (Fycompa) as an adjunctive treatment of primary generalized tonic-clonic seizures for patients aged 12 years or older with epilepsy.

The FDA today expanded the indication for perampanel hydrate (Fycompa) as an adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures for patients aged 12 years or older with epilepsy.

The antiepileptic agent was approved based on a study involving 164 patients divided between placebo and Fycompa. Those in the intervention group saw fewer PGTC seizures compared with those on placebo. While about 12% of those in the placebo group experienced a PGTC seizure in the 13-week maintenance period, almost 31% of those taking Fycompa were PGTC seizure-free.

Adverse side effects of Fycompa may include dizziness, fatigue, headache, somnolence, and irritability.

Back in 2012, the medication was approved as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures for patients aged 12 years or older with epilepsy, and it was made available in 2014.

In a press release, manufacturer Eisai Co. noted that GTC seizures are the most important risk factor related to sudden unexpected death in epilepsy.

“Through this indication expansion, Fycompa can now be used as an adjunctive treatment for primary, in addition to, secondarily generalized tonic-clonic seizures,” the company stated.