FDA Approves New Drug for Seizures

The FDA has approved eslicarbazepine acetate (Aptiom) for the treatment of partial seizures in adults with epilepsy. The medication is indicated as an add-on therapy for patients with epilepsy.

Three clinical studies in which patients with partial epilepsy were randomly assigned to receive Aptiom or placebo found that the new drug is effective in reducing the frequency of seizures.

Like other epilepsy medications, Aptiom may cause suicidal thoughts or actions in a very small number of people.

The most common side effect reported in clinical trials of the drug included dizziness, drowsiness, nausea, headache, double vision, vomiting, fatigue and loss of coordination. These and other side effects and recommendations for monitoring are included in approved labeling.

Aptiom was approved with a Medication Guide that must be distributed each time the patient renews his or her prescription.

Eslicarbazepine is marketed by Sunovion Pharmaceuticals.