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Retigabine Significantly Reduces the Number of Seizures in Adults With Inadequately Controlled Partial-Onset Epilepsy
Date:12/6/2008

SEATTLE, Dec. 6 /PRNewswire-FirstCall/ -- Results from RESTORE 2, a placebo-controlled, Phase III study demonstrated that the investigational compound retigabine significantly reduced the number of seizures in adult patients with refractory partial-onset epilepsy when a 600 mg or 900 mg dose was added to a patient's current anti-epileptic drug (AED) therapy. Prior to enrollment in the retigabine clinical trials, patients were experiencing seizures despite taking stable doses of up to three AEDs.

Retigabine has a different mechanism of action than currently approved AEDs. Retigabine is a neuronal potassium channel opener, which helps control neuronal excitability. In epilepsy patients, brain cells can become overly excited, disrupting normal brain activity and causing seizures.

"Approximately 30 percent of epilepsy patients are not well-controlled despite treatment with existing anti-epileptic drugs," said Jacqueline A. French, M.D., Professor of Neurology, New York University Medical Center and an investigator in the study. "Many of the currently available AEDs regulate sodium channels or calcium channels in the brain to help reduce seizures. Given the unmet medical need, it is hoped that medications with novel mechanisms of action, like retigabine, will improve outcomes in patients with refractory epilepsy."

The RESTORE 2 study results were presented at the 62nd Annual Meeting of the American Epilepsy Society in Seattle on Saturday December 6, 2008. In addition to the Phase III results, five other studies of retigabine were presented at AES.

About the Clinical Trials

The Phase III program for retigabine consisted of two randomized, double- blind, placebo-controlled, multi-center, parallel-group studies that assessed the efficacy, safety and tolerability of retigabine as an adjunctive treatment for adult epilepsy patients with refractory partial-onset seizures.
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SOURCE GlaxoSmithKline; Valeant Pharmaceuticals International
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