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Data Presented at the American Academy of Neurology Show XP13512/GSK1838262 Significantly Improved Symptoms of Moderate-to-Severe Primary Restless Legs Syndrome
Date:4/17/2008

Additional Data Demonstrate Predictable, Extended Exposure with Sustained-

Release Formulation

CHICAGO, April 17 /PRNewswire/ -- Data from the first pivotal study of XP13512/GSK1838262, a sustained-release investigational compound to treat Restless Legs Syndrome (RLS), showed that it significantly improved the symptoms of moderate-to-severe primary RLS compared to placebo, and was generally well-tolerated when administered once-daily for 12 weeks.

Data from the PIVOT RLS I (Patient Improvement in Vital Outcomes following Treatment for RLS) clinical trial, formerly designated as study XP052, were presented today at the 60th annual meeting of the American Academy of Neurology (AAN). The investigational compound is being developed by XenoPort (Nasdaq: XNPT) and GlaxoSmithKline (NYSE: GSK).

"This novel compound is the first non-dopaminergic agent to demonstrate efficacy in treating the symptoms of RLS in large controlled clinical trials," said Clete Kushida, M.D., director of the Stanford Center for Human Sleep Research and a clinical investigator in the PIVOT RLS I clinical trial.

Additional data presented at the meeting compared the pharmacokinetic profiles of an immediate-release formulation of XP13512, a sustained-release formulation of XP13512, and commercially-available gabapentin. The sustained- release formulation of XP13512, used in the PIVOT RLS I clinical trial presented at AAN, provided predictable and extended exposure in healthy volunteers compared with c
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SOURCE GlaxoSmithKline
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