Medication Monitor



Generic Name (Trade Name—Company)
Notes
October 23, 2012

Perampanel

(Fycompa—Eisai)
Novel AED approved

Uses:

Treatment of partial onset seizures

FDA announced the approval of perampanel for the treatment of partial onset seizures in patients with epilepsy ages 12 years and older. This novel antiepileptic drug (AED) exerts its mechanism of action by being a selective noncompetitive antagonist of AMPA receptors, the major subtype of ionotropic glutamate receptors.

Approval was based on data from three pivotal, Phase III trials in patients with partial onset seizures. Results from these trials showed that perampanel improved seizure control compared with those taking placebo. In terms of safety, the most common adverse reactions reported by patients receiving perampanel included 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 agency noted that perampanel was approved with a boxed warning alerting health providers and patients about the risk of serious and sometimes life-threatening neuropsychiatric events, including violent and homicidal behavior. In addition, FDA noted that perampanel will be dispensed with a patient Medication Guide that provides important instructions on its use and drug safety information.