FDA Approves Perampanel for Partial-Onset Seizures

Susan Jeffrey

October 22, 2012

The US Food and Drug Administration (FDA) today announced approval of perampanel tablets (Fycompa, Eisai Inc) for treatment of partial-onset seizures in patients with epilepsy 12 years of age and older.

"Some people with epilepsy do not achieve satisfactory seizure control from treatments they are currently using," said Russell Katz, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, in a statement. "It is important to have a variety of treatment options available for patients with epilepsy."

The approval is based on data from 3 clinical trials that showed improvement in seizure control among patients receiving perampanel vs those receiving placebo. The trials, studies 304, 305, and 306, all of which were part of the Examining Perampanel Observations from Research Experience (EXPLORE) program carried out by Eisai, were previously reported by Medscape Medical News. The first-in-class agent is a highly selective, noncompetitive α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid-type glutamate receptor antagonist

The most common adverse reactions reported by patients treated with perampanel include dizziness, drowsiness, fatigue, irritability, falls, upper respiratory tract infection, weight increase, vertigo, ataxia, gait disturbance, balance disorder, anxiety, blurred vision, dysarthria, asthenia, aggression, and hypersomnia.

The drug's label will include a boxed warning to alert prescribers and patients about the risk for serious neuropsychiatric events, including irritability, aggression, anger, anxiety, paranoia, euphoric mood, agitation, and mental status changes, the FDA statement adds.

"Some of these events were reported as serious and life-threatening," the FDA notes. "Violent thoughts or threatening behavior was also observed in a few patients." Healthcare professionals should closely monitor patients during the titration period when higher doses are used, the agency adds.

Perampanel will be dispensed with a patient Medication Guide that provides important instructions on its use and drug safety information, the statement notes.