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). 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, GlaxoSmithKline Neurosciences Medicine Development Center. “GSK has been committed to helping patients and healthcare professionals better understand and treat this condition. We are pleased to provide a new treatment for moderate-to-severe primary Restless Legs Syndrome.”

“This significant milestone represents the culmination of XenoPort’s efforts to develop a non-dopaminergic therapy for patients with Restless Legs Syndrome,” said Ronald W. Barrett, Ph.D., XenoPort’s chief executive officer. “XenoPort is honored to have contributed to the efforts to find new treatments for Restless Legs Syndrome, and we hope that we can continue to develop other important medicines that can provide meaningful treatment benefit to sufferers of central nervous system disorders.”