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FDA Approves Once-A-Day Lamictal(R)XR(TM) as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures
Date:1/29/2010

breakthrough bleeding, while taking Lamictal XR and birth control pills. These are not all the possible side effects of Lamictal XR.

For full prescribing information for Lamictal XR, including Boxed Warning, please visit www.gsk.com.

Editor's Note: About the Clinical Trial

The approval of Lamictal XR (lamotrigine) as add-on therapy for primary generalized tonic-clonic seizures was based upon data from a 19-week, international, multicenter, double-blind, randomized, placebo-controlled study in 143 patients 13 years of age and older (n = 70 on Lamictal XR and n = 73 on placebo). Patients with at least three primary generalized tonic-clonic seizures during an eightweek baseline phase were randomized to 19 weeks of treatment with Lamictal XR or placebo added to their current antiepileptic drug (AED) regimen of up to two drugs. Patients were dosed on a fixed-dose regimen, with target doses ranging from 200 mg/day to 500 mg/day of Lamictal XR based on concomitant AED(s) (target dose = 200 mg for valproate, 300 mg for AEDs not altering plasma lamotrigine, and 500 mg for enzyme-inducing AEDs).

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 percent in patients treated with Lamictal XR and 32 percent in patients treated with placebo, a difference that was statistically significant, defined as a two sided p value < 0.05.

The proportion of patients achieving any particular level of reduction in primary
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SOURCE GlaxoSmithKline
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