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FDA Approves Once-Daily Lamotrigine XR for Primary Generalised Tonic-Clonic Seizures NEW YORK -- February 1, 2010 -- The US Food and Drug Administration has approved lamotrigine extended-release tablets (Lamictal XR) as once-a-day, add-on therapy for patients with epilepsy aged 13 years and older with primary generalised tonic-clonic seizures. The approval was based upon data from a 19-week, international, multicentre, double-blind, randomised, placebo-controlled study in 143 patients aged 13 years and older with at least 3 primary generalised tonic-clonic seizures during an 8-week baseline phase. Of the patients, 70 were randomised to lamotrigine XR and 73 were assigned to placebo for 19 weeks in addition to their current antiepileptic drug (AED) regimen of up to 2 drugs. Patients were dosed on a fixed-dose regimen, with target doses ranging from 200 mg/day to 500 mg/day of lamotrigine XR based on concomitant AED(s). The primary efficacy endpoint was percent change from baseline in primary generalised tonic-clonic seizure frequency during the double-blind treatment phase. For the intent-to-treat population, the median percent reduction in primary generalised tonic-clonic seizure frequency was 75% in patients treated with lamotrigine XR and 32% in patients treated with placebo (P < 0.05). The proportion of patients achieving any particular level of reduction in primary generalised tonic-clonic seizure frequency was consistently higher for the group treated with lamotrigine XR compared with the placebo group. For example, 70% of patients randomized to lamotrigine XR experienced a 50% or greater reduction in primary generalised tonic-clonic seizure frequency, compared with 32% of patients randomised to placebo. The most common adverse event was headache, which was reported among 14% of patients taking lamotrigine XR and 16% of patients taking placebo. Other common adverse events in patients taking lamotrigine XR included vomiting (10%), nausea (7%), fever (7%), dizziness (6%), double vision (6%), tremor (6%), nasopharyngitis (3%), rash (3%), and anxiety (3%). Patients with generalised tonic-clonic seizures currently taking immediate-release lamotrigine twice-daily can be converted directly to once-a-day lamotrigine XR using the same total daily dose. SOURCE: GlaxoSmithKline E-mail this page to a friend or colleague! To print, use this version