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FDA Approves Lamictal®XR™ (Lamotrigine) for Conversion to Monotherapy for Treatment of Partial Seizures in Appropriate Patients
Date:4/25/2011

RESEARCH TRIANGLE PARK, N.C., April 25, 2011 /PRNewswire/ -- GlaxoSmithKline (GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved Lamictal® XR™ (lamotrigine) Extended-Release Tablets for conversion to monotherapy in patients 13 years and older with partial seizures taking one anti-epileptic drug. This is a new indication for Lamictal XR which is already approved as add-on treatment for partial seizures and primary generalized tonic-clonic seizures in patients in this age group. Safety and effectiveness of Lamictal XR have not been established as initial monotherapy or for simultaneous conversion to monotherapy from two or more concomitant AEDs.

"We are committed to providing new and effective treatment options for patients," said Atul Pande, MD, senior vice president, Neurosciences Medicines Development Center, GlaxoSmithKline.  "The approval of Lamictal XR for conversion to monotherapy will provide an additional therapeutic option for appropriate patients."  

The approval was based on data from study LAM30055, an international, multicenter, historical control study evaluating 300 mg/day and 250 mg/day of Lamictal XR for conversion to monotherapy in patients 13 years and older with partial seizures taking one anti-epileptic drug.   In 'conversion to monotherapy,' an additional anti-epileptic drug is added to a patient's existing anti-epileptic drug therapy regimen while the original therapy is gradually withdrawn. LAM30055 used a historical control based on a pooled analysis of previously conducted conversion to monotherapy studies.

Of the 226 patients treated with Lamictal XR, eight patients reported 10 treatment-emergent serious adverse events, including one serious adverse event of rash. Other serious adverse events were seizure related, trauma, neoplasm, upper gastrointestinal hemorrhage, pyrexia and respiratory failure. No de
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SOURCE GlaxoSmithKline
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