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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

RESEARCH TRIANGLE PARK, N.C., Jan. 29 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration has approved Lamictal®XR™ (lamotrigine) Extended-Release Tablets as once-a-day, add-on therapy for epilepsy in patients ages 13 years and older with primary generalized tonic-clonic seizures.  This is an expanded label, as Lamictal XR is approved for partial onset seizures (with or without secondary generalization) for patients in this age group.

Primary generalized tonic-clonic seizures, known formerly as "grand mal" seizures, are considered the most common form of generalized (affecting both sides of the brain) seizure, occurring in approximately 20 percent of patients with epilepsy.  Patients experiencing a generalized tonic-clonic seizure usually lose consciousness and collapse.  This is followed by muscle stiffening (the tonic phase) and then jerking involving both sides of the body (the clonic phase).  

In a clinical study, the addition of Lamictal XR reduced seizure frequency more than placebo in patients with uncontrolled primary generalized tonic-clonic seizures, when used in adjunctive therapy for patients 13 years of age and older.  The patients in the study were not adequately controlled despite being on one or two anti-epileptic drugs.  

"We were encouraged that the study showed such a significant reduction in the number of primary generalized tonic-clonic seizures in patients who received Lamictal XR in addition to their current regimen.  Over the 19 week treatment period, the median percent reduction in weekly seizure frequency was 75 percent in patients treated with Lamictal XR c
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SOURCE GlaxoSmithKline
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