GSK, XenoPort Submit NDA for RLS Drug

GlaxoSmithKline and XenoPort, Inc. have submitted a NDA to the FDA requesting approval of Solzira Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). RLS affects an estimated 12 million people in the U.S. and can result in symptoms that disrupt sleep and impact daily activities.
   
The NDA submission is based on a Phase III clinical development program for Solzira in RLS patients, including data from two randomized, double-blind, placebo-controlled trials evaluating the safety and efficacy of Solzira over 12 weeks. The submission also included results from a third trial evaluating the ability of the drug to maintain efficacy in treating RLS symptoms over a nine-month period. The most common side effects of Solzira were dizziness and somnolence.
   
“GSK is committed to bringing innovative products to patients where there is unmet medical need,” said Atul Pande, M.D., senior vice president, GSK Neurosciences Medicine Development Center. “We believe that Solzira may offer a new therapeutic option to treat primary Restless Legs Syndrome, a condition that includes both sensory and motor symptoms.”
   
“We are very encouraged by the results that we have seen in the clinical development program for Solzira,” said Ronald W. Barrett, Ph.D., chief executive officer of XenoPort. “Solzira is the first non-dopaminergic compound to demonstrate efficacy in large, controlled clinical trials for the treatment of primary RLS, and we believe it will offer patients a beneficial alternative to currently approved therapies.”