Felbamate: successful development of a new compound for the treatment of epilepsy

Felbamate (FBM) is an effective and safe novel antiepileptic drug (AED) for add-on treatment in adults with refractory partial seizures as shown in three pivotal controlled trials. In addition, FBM is effective and safe in monotherapy in adults with refractory partial seizures. FBM is also effective and safe as add-on therapy for children and adults with refractory Lennox-Gastaut syndrome. The effective daily dosage is approximately 30-45 mg/kg divided into three or four doses with resulting plasma concentrations of 50-80 mg/L. The safety profile of FBM is limited to mild gastrointestinal complaints, insomnia, and nonspecific CNS symptoms. Six pivotal controlled trials, with both classic and innovative design, showed that FBM is a useful AED.