Lamictal XR approved as add-on therapy for primary generalized tonic-clonic seizures

The FDA has approved Lamictal XR (lamotrigine extended-release tablets, from GlaxoSmithKline) as a once daily, add-on therapy for epilepsy in patients ≥13 years of age with primary generalized tonic-clonic seizures. This approval was based on data from a 19-week, international, multicenter, double-blind, randomized, placebo-controlled study in 143 patients ≥13 years of age with at least three primary generalized tonic-clonic seizures during an eight week baseline phase. Patients were randomized to receive Lamictal XR or placebo in addition to their current antiepileptic drug (AED) regimen of up to two drugs.

The primary efficacy endpoint was percent change from baseline in primary generalized tonic-clonic seizure frequency during the double-blind treatment phase. For the intent-to-treat population, the median percent reduction in primary generalized tonic-clonic seizure frequency was 75% in patients treated with Lamictal XR and 32% in patients treated with placebo (p< 0.05).

Lamictal XR is already indicated as an adjunct in partial onset seizures with or without secondary generalization in patients ≥13 years of age.

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