The drug, branded Aptiom by Sunovion Pharmaceuticals, is now approved for the treatment of “partial” seizures of the type seen in epilepsy patients. The drug was approved following three clinical trials that showed the drug is effective at reducing the frequency of seizures in patients with epilepsy.
“Some patients with epilepsy do not achieve satisfactory seizure control from existing treatments,” said Dr. Eric Bastings, acting director of Neurology Products at the FDA’s Center for Drug Evaluation and Research. “It is important we continue to make new treatment options available to patients.”
Epilepsy is a brain disorder that can cause electrical disturbances in the brain. People with epilepsy can suffer from odd behaviors or movements, or even sometimes suffer seizures that are caused by intense nerve cell activity in the brain. Serious seizures can even lead to convulsions or loss of consciousness. The FDA estimates that around 200,000 Americans will experience epilepsy each year.
Aptiom has many of the same side-effects that other anti-seizure medications have, including headache, nausea, drowsiness, dizziness, double-vision, vomiting, and fatigue. The FDA also warns that it could cause suicidal thoughts for a smaller subset of patients.