FDA Approves Drug to Treat Seizures in Epilepsy Patients

(National Institute of Drug Abuse)

The U.S. Food and Drug Administration approved the drug perampanel, given in tablet form to treat partial onset seizures in patients with epilepsy ages 12 years and older. Perampanel is marketed under the brand name Fycompa by Eisai Inc. of Woodcliff Lake, New Jersey, and headquartered in Tokyo.

Epilepsy is a brain disorder characterized seizures caused by abnormal or excessive activity of nerve cells in the brain. Partial or focal seizures occur when this electrical activity remains in a limited area of the brain, but can spread to other parts of the brain. Symptoms can affect many parts of the body, depending on the areas of the brain affected by the seizure, with examples including abnormal muscle contractions, staring spells, and repetitive movements.

Perampanel targets activity of glutamate, an excitatory transmitter, on neural receptors in the brain. The drug has been the subject of a series of phase 3 clinical trials with a total of 1,480 epilepsy patients aged 12 years and older. The randomized, double-blind, multiple-site trials tested perampanel against a placebo, with the goal of identifying the minimal effective dose or to evaluate extended dose ranges. The trials showed improvement in seizure control in patients taking Fycompa compared with those taking a placebo.

In July 2012, the EU approved perampanel for distribution in Europe, for a once-daily dose. Eisai says the drug is being tested in a phase 3 trial as a generalized treatment for epilepsy.

In the clinical trials, says FDA, the most common adverse reactions were dizziness, drowsiness, fatigue, irritability, falls, upper respiratory tract infection, weight increase, vertigo, loss of muscle coordination, gait disturbance, balance disorder, anxiety, blurred vision, stuttering, weakness, aggression, and excessive sleep.

FDA says Fycompa’s label will have a boxed warning to alert prescribers and patients about the risk of serious neuropsychiatric events, including irritability, aggression, anger, anxiety, paranoia, euphoric mood, agitation, and mental status changes. The agency says Fycompa will be dispensed with a patient medication guide providing instructions on its use and drug safety information.

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