FDA approves new treatment for epilepsy in children
The US FDA has granted marketing clearance for GlaxoSmithKline's Lamictal (lamotrigine) tablets as add-on therapy in partial seizures in children age two years old and up.
The US FDA has granted marketing clearance for GlaxoSmithKline's 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 generalised seizures of Lennox-Gastaut Syndrome in children.
Approval of Lamictal was based on a clinical study, 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).
In the 18-week, double-blind, placebo-controlled study involving 199 patients aged two to 16 years, those treated with Lamictal as adjunctive therapy ex-perienced a 36% reduction in frequency of all partial seizures, compared with 7% in placebo group, while 42% of Lamictal patients experienced a 50% reduction in partial seizures, compared with 16% in placebo group.
'FDA-approved therapies for children with epilepsy are limited, so any medication to effectively control seizures in this population with a favourable tolerability profile, provides an important new option to manage this condition,' said Dr Michael Duchowny, director of the Comprehensive Epilepsy Program at Miami Children's Hospital.