Dr. Russell Katz, director of the Division of Neurology Products in the Food and Drug Administration's Center for Drug Evaluation and Research, said partial seizures are the most common type seen in people with epilepsy.
Epilepsy is a brain disorder in which there is abnormal or excessive activity of nerve cells in the brain. Partial seizures affect only a limited or localized area of the brain, but can spread to other parts of the brain, Katz said. Seizures cause a wide range of symptoms, including spasms, unusual behavior and generalized convulsions with loss of consciousness.
"Some people with epilepsy do not achieve satisfactory seizure control from treatments they are currently using," Katz said in a statement. "It is important to have a variety of treatment options available for patients with epilepsy."
Three clinical trials showed improvement in seizure control in patients taking Fycompa compared with those taking a placebo.
The most common adverse reactions reported by patients receiving Fycompa in clinical trials included: 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.
Fycompa will be dispensed with a patient Medication Guide that provides important instructions on its use and drug safety information, the FDA said.
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