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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

ompared to 32 percent for those taking placebo," said Victor Biton, M.D., director of the Arkansas Epilepsy Program and Clinical Trials, Inc., in Little Rock, Ark.  "The approval of once-a-day Lamictal XR for this very serious seizure type gives us a convenient and effective new option for improving the care of our patients with epilepsy."

The most common adverse event was headache, which was reported among 14 percent of patients taking Lamictal XR and 16 percent of patients taking placebo. Other common adverse events in patients taking Lamictal XR included vomiting (10 percent), nausea (7 percent), fever (7 percent), dizziness (6 percent), double vision (6 percent), tremor (6 percent), nasopharyngitis (3 percent), rash (3 percent) and anxiety (3 percent).

Lamictal XR was initially approved in May 2009 for the treatment of partial onset seizures with or without secondary generalization in adults or adolescents. Partial onset seizures, which are limited to one part of the brain, are the most common type of seizure experienced by people with epilepsy.  Partial seizures may sometimes spread to both sides of the brain, an occurrence classified as secondary generalization. The safety and effectiveness of Lamictal XR have not been established in patients under the age of 13.  

Patients with generalized tonic-clonic seizures currently taking immediate-release Lamictal twice-daily can be converted directly to once-a-day Lamictal XR using the same total daily dose.

Patented GlaxoSmithKline Extended-Release Technology

Lamictal XR Extended-Release Tablets are enteric-coated and contain a modified release formulation in the center of the tablet. There is a specially designed opening in the enteric coating on both sides of the tablet tha
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SOURCE GlaxoSmithKline
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