The U.S. Food and Drug Administration has approved perampanel (Fycompa) for monotherapy treatment of partial-onset seizures (POS) in patients aged 12 years or older as of July 27. It was approved in 2012 for adjunctive use for POS and primary, generalized tonic-clonic seizures in patients aged 12 years or older.
Three clinical trials showed improvement in seizure control for the patients with POS taking perampanel, compared with placebo.
The FDA approved the supplemental new drug application pertaining to this use filed by Eisai, the manufacturer of perampanel. The U.S. Drug Enforcement Agency has designated the drug a Schedule III federally controlled substance, since it can be abused and can lead to dependence. Perampanel also has a risk of causing psychiatric problems.
The drug is available in tablets from 2 mg to 12 mg and as an oral suspension formulation. It is taken once daily.
“Approximately one-third of people living with epilepsy have seizures that are not adequately controlled,” said Robert T. Wechsler, MD, PhD , medical director of the Idaho Comprehensive Epilepsy Center, in Eisai’s press release . “Having a new monotherapy option for partial-onset seizures that is once a day gives physicians and patients an effective treatment option that has the potential to make a difference in patients’ lives.”
