Published October 23, 2012
U.S. health regulators approved Japanese drugmaker Eisai Co Ltd's Fycompa tablets to treat partial seizures in epileptic patients, saying current treatments on the market were unsatisfactory in controlling seizures in some patients.
Eisai's drug, chemically known as perampanel, works by blocking the action of the neurotransmitter glutamate, which may cause excessive electrical activity in the brain, resulting in seizures.
"It is important to have a variety of treatment options available for patients with epilepsy," said Russell Katz, an official at the U.S. Food and Drug Administration's Center for Drug Evaluation and Research.
The drug was approved specifically for epileptic patients aged 12 and above, based on Fycompa outperforming a placebo in three clinical studies, the FDA said.
Dizziness, weight increase, blurred vision and excessive sleep were among some of the most common adverse events reported by patients taking Fycompa.
The drug will carry a boxed warning alerting prescribers and patients about the risks of aggression, anger, anxiety, paranoia and agitation among other mental status changes, the health regulator said.
The drug will be sold along with a patient medication guide containing instructions on its use and drug safety information.