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GSK, XenoPort’s RLS Drug Gains FDA Approval

GlaxoSmithKline and XenoPort, Inc. received approval from the FDA for Horizant (gabapentin enacarbil) Extended-Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

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By: Tim Wright

Editor-in-Chief, Contract Pharma

GlaxoSmithKline and XenoPort, Inc. received approval from the FDA for Horizant (gabapentin enacarbil) Extended-Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). The approval is based on two 12-week trials in adults demonstrating the efficacy of Horizant in patients with moderate-to-severe primary RLS. “Restless Legs Syndrome remains under-recognized, and many patients go untreated as a result,” said Atul Pande, M.D., senior vice president, GlaxoSmi...

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