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FDA Approves Lamotrigine XR Tablets for Once-a-Day Add-on Therapy

RESEARCH TRIANGLE PARK, N.C., June 1 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE:GSK) announced today that the U.S. Food and Drug Administration has approved Lamictal(R)XR(TM) (lamotrigine) Extended-Release Tablets as once-a-day add-on therapy for epilepsy patients 13 years of age or older with partial onset seizures. Lamictal XR reduced seizures in patients who were inadequately controlled on current therapy.

Lamictal XR reduced the frequency of partial seizures during a 19-week study. More patients who took Lamictal XR had a significant reduction in seizure frequency compared with placebo. These results were statistically significant. Patients enrolled in the study were inadequately controlled on one or two antiepileptic drugs. In fact, half of these patients were inadequately controlled on two antiepileptic drugs.

"Many patients require multiple doses of one or more medications to control their epilepsy, which makes taking their medicines even more challenging," said Dean Naritoku, M.D., Professor and Chairman of Neurology, University of South Alabama, Mobile, AL. "Lamictal XR is an important once-daily advance for patients with epilepsy who still experience seizures while taking their current therapy."

Lamictal XR is approved as add-on therapy for adult and adolescent patients who experience partial seizures with or without secondary generalization. Partial 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 affect the entire 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 partial seizures currently taking immediate-release Lamictal twice-daily can be converted directly to once-a-day Lamictal XR using the same total daily dose. Lamictal XR will be available in pharmacies this summer.

Source: GlaxoSmithKline

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