The U.S. Food and Drug Administration has approved GlaxoSmithKline's new drug Lamictal (lamotrigine) as an addition for children whose partial seizures are inadequately controlled on their existing therapy. This new indication is an expansion of 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 and they begin with abnormal electrical activity in a particular location in the brain. The effect of these seizures include lip smacking, a dazed state or jerking movements of certain body parts.
The approval of the drug was based on a clinical study that demonstrated 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 anti-epilepsy drugs (AEDs). The study was a 18 week placebo controlled study in which 200 patients aged between 2 and 15 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: 99, placebo: 101). The results showed significant reductions in the frequency of all partial seizures in children and adolescents with epilepsy when Lamictal was added to their AED regimen.
Michael Duchowny, director of the Comprehensive Epilepsy Program at Miami Children's Hospital said that Lamictal would be a welcome addition as FDA-approved therapies for children with epilepsy are limited and any clinically proven medication which can effectively control seizures in children would be an important new option to manage this condition.