GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) granted marketing clearance for Lamictal (lamotrigine) Tablets as add-on therapy in partial seizures in children age two years old and up. This new indication expands the already-approved indications for adjunctive use in adults with partial seizures, and for the generalized seizures of Lennox-Gastaut Syndrome in children two years of age and older.

Partial seizures are the most common type of epilepsy, affecting approximately 70% of all people with the illness.Partial seizures begin with abnormal electrical activity in a particular location in the brain.Specific effects of this kind of seizure depend on the part of the brain involved, and may include a dazed state, lip smacking, or jerking movements of certain body parts.According to the Epilepsy Foundation, epilepsy affects 2.3 million Americans of all ages, including approximately 300,000 American children under the age of 14.

"FDA-approved therapies for children with epilepsy are limited, so any medication that can be clinically proven to effectively control seizures in this population with a favorable tolerability profile, provides an important new option to manage this condition," said Michael Duchowny, director of the Comprehensive Epilepsy Program at Miami Children's Hospital."Lamictal is a welcome addition for children whose partial seizures are inadequately controlled on their existing therapy."

Approval of Lamictal was based on a clinical study, published in the journal Neurology, demonstrating the efficacy of the drug as add-on therapy in pediatric patients who were still having frequent partial seizures (at least four per month) despite optimal doses of other antiepilepsy drugs (AEDs).

According to Dr. Duchowny, a lead investigator in this study, there were significant reductions in the frequency of all partial seizures in children and adolescents with epilepsy when Lamictal was added to their AED regimen. In the 18-week, double-blind, placebo-controlled study, 199 patients, ages two to 16 years who were still having frequent seizures despite use of other AEDs, were randomized to treatment with Lamictal or placebo added to their current AED regimen of up to two drugs (Lamictal: 98, placebo: 101). The primary efficacy endpoint was percentage change from baseline in all partial seizures.