FDA Approves Aptiom to Treat Seizures in Adults

FDA has 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 US 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, MD, 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 co-ordination. These and other side-effects and recommendations for monitoring are described in the drug label.

Similar to other antiepileptic drugs, Aptiom may cause suicidal thoughts or actions in a very small number of people. 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.