The U.S. Food and Drug Administration (FDA) has granted marketing clearance for Trileptal (oxcarbazepine) tablets and oral suspension for use as monotherapy in children with partial seizures four years of age and older. Trileptal is the first antiepileptic drug (AED) to be approved as a monotherapy in children since 1978.

Many children with epilepsy take multiple medications to control their seizures; however, treating seizure disorders with one medication is preferred as it usually means fewer side effects and improved compliance.

"The approval of Trileptal as a pediatric monotherapy is a step forward in the treatment of childhood epilepsy," said Tracy Glauser, Associate Professor of Pediatrics and Neurology, Director of the Comprehensive Epilepsy Program, Cincinnati Children's Hospital Medical Center and Trileptal clinical trial investigator. "Trileptal has a proven track record of effective seizure control with favorable safety and tolerability as monotherapy in adults. Now the benefits of Trileptal monotherapy can be extended to children four years of age and older."

The indication is based on data from four multicenter, randomized, double-blind, controlled trials. The safety profile in children was established from data in more than 1,000 children from 20 studies.

Trileptal is currently approved in more than 60 countries worldwide for use as monotherapy and adjunctive therapy in children and adults.