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FDA Approves Fycompa for Partial Onset Seizures in Epilepsy

epilepsy, FDA, Fycompa, perampanel

The US Food and Drug Administration (FDA) has announced approval for the Eisai Inc. drug Fycompa (perampanel) as a treatment for partial onset seizures in epilepsy patients aged 12 and over.

Epilepsy is a brain disorder in which a person has repeated seizures over time, the result of disturbed brain activity that causes changes in attention or behavior. Seizures can range from benign to severe, life-threatening and disabling. About 60% of patients have “partial seizures” (sometimes called focal seizures) that only affect a limited or localized part of the brain, but can spread to other parts.

The Institute of Medicine suggests there are 2.2 million people with epilepsy in the US.

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Fycompa is a selective, non-competitive AMPA receptor antagonist. The AMPA receptor is widely present in almost all excitatory neurons and is believed to play a role in a large number of central nervous system diseases. Fycompa targets glutamate, the main excitatory neurotransmitter in the brain. Excessive glutamate release has been observed during seizure activity in humans.

In Phase 3 studies, patients taking Fycompa showed better seizure control than those treated with a placebo. The most common side effects reported include blurred vision, stuttering, drowsiness, fatigue, irritability, dizziness, upper respiratory tract infection, weight increase, falls, loss of muscle coordination, balance disorder, excessive sleep, and anxiety. A boxed warning will be included on the package alerting prescribers of some of the more serious life-threatening events such as paranoia, agitation and violent thoughts or behaviors.

Fycompa will be dispensed with a Medication Guide with important instructions on how to use it safely. It will be available in 2-, 4-, 6-, 8-, 10-, and 12-mg oral tablets.

Lonnel Coats, President and Chief Executive Officer of Eisai Inc, says, "The FDA approval of Fycompa is an important development for the treatment of patients who continue to have seizures despite being on other prescription medications for epilepsy." Russell Katz, director of the FDA’s Division of Neurology Products, notes that in about 25-30% of patients with epilepsy, seizures cannot be controlled with current treatment. "It is important to have a variety of treatment options available for patients with epilepsy."

Reference: US Food and Drug Administration, FDA News Release October 22, 2012. “FDA approves Fycompa to treat seizures”