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

The program, called RESTORE (Retigabine Efficacy and Safety Trial for Partial- Onset Epilepsy) 1 and 2, involved approximately 120 sites in more than 17 countries worldwide.

RESTORE 1 evaluated a 1200 mg daily dose of retigabine (the highest dose in the Phase III program) versus placebo, while RESTORE 2 evaluated 600 mg and 900 mg daily doses of retigabine versus placebo. In these studies, retigabine demonstrated a statistically significant reduction in seizures compared to placebo at all three doses when added to patients' current AED therapy. Additionally, RESTORE 2 showed a dose-dependent response when the dose of retigabine was increased from 600 mg to 900 mg daily.

Tolerability of retigabine was generally dose-dependent. The most common side effects associated with retigabine in the RESTORE trials occurring in greater than or equal to 10 percent of patients included dizziness, somnolence, fatigue, confusion, dysarthria (slurred speech), ataxia (loss of muscle coordination), urinary tract infection, blurred vision, tremor, and nausea. Urinary bladder effects, while monitored during the studies, were uncommonly reported.

GlaxoSmithKline (NYSE: GSK) (LSE: GSK) and Valeant Pharmaceuticals International (NYSE: VRX) entered into an exclusive worldwide collaboration agreement for retigabine earlier this year. The companies plan to file a New Drug Application in the United States and a Marketing Authorization Application in Europe in 2009.

About Epilepsy

Epilepsy, defined by recurrent, unprovoked seizures, is a change in sensation, awareness or behavior caused by an electrical disturbance in the brain. The kind of seizure a person has depends on which part and how much of the brain is affecte
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SOURCE GlaxoSmithKline; Valeant Pharmaceuticals International
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