The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.
Epilepsy is a brain disorder caused by abnormal or excessive activity in the brain's nerve cells. Approximately 200,000 new cases of seizures and epilepsy occur in the United States each year.
Aptiom is approved for the treatment of partial seizures, the most common type of seizure seen in people with epilepsy. Seizures can cause a wide range of symptoms, including repetitive limb movements, unusual behavior and generalized convulsions with loss of consciousness. Seizures can have serious consequences, including injury and death.
"Some patients with epilepsy do not achieve satisfactory seizure control from existing treatments," said Eric Bastings, M.D., acting director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "It is important we continue to make new treatment options available to patients."
Three clinical studies in which participants with partial epilepsy were randomly assigned to receive Aptiom or placebo demonstrated that Aptiom is effective in reducing the frequency of seizures.
The most common side effects reported by patients receiving Aptiom in clinical trials included dizziness, drowsiness, nausea, headache, double-vision, vomiting, fatigue and loss of coordination. These and other side effects and recommendations for monitoring are described in the drug label.
Like other antiepileptic drugs, Aptiom may cause suicidal thoughts or actions in a very small number of people. Patients should contact their health care professionals right away if they have thoughts about suicide or dying, new or worsened anxiety or depression, or other unusual changes in behavior or mood.
Aptiom is being approved with a Medication Guide that provides patients with important information about the medication that can help patients avoid serious adverse events. The guide will be distributed each time a patient fills their prescription.
Aptiom is marketed by Sunovion Pharmaceuticals Inc., based in Marlborough, Mass.
For more information:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.