HealthDay News — The FDA has approved eslicarbazepine acetate (Aptiom) as an add-on drug to help treat adults with partial epileptic seizures.
Epilepsy is diagnosed in some 200,000 people annually in the United States, with partial seizures being the most common type of seizure.
“Some patients with epilepsy do not achieve satisfactory seizure control from existing treatments,” Eric Bastings, MD, acting director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research said in a press release. “It is important we continue to make new treatment options available to patients.”
Results from three clinical trials show that eslicarbazepine acetate is effective in reducing the frequency of seizures among participants with partial epilepsy compared with placebo. The most common side effects noted were dizziness, drowsiness, nausea, headache, double vision and loss of coordination.
As with other anti-epileptic drugs, eslicarbazepine acetate may trigger thoughts of suicide in a small number of users, the FDA said. People who take the drug should contact a doctor immediately if they have thoughts of suicide or worsening anxiety or depression, the agency warned.
Due to these risks, eslicarbazepine acetate will be accompanied by a medication guide to help patients avoid serious adverse events.
The medication is marketed by Sunovion Pharmaceuticals, based in Marlborough, Mass.