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news.GlaxoSmithKline and XenoPort have announced that a new drug application has been submitted to the FDA requesting approval of Solzira extended release tablets for the treatment of moderate-to-severe primary restless legs syndrome.
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The new drug application (NDA) submission is based on a comprehensive Phase III clinical development program for Solzira in patients with moderate-to-severe primary restless legs syndrome (RLS), including data from two randomized, double-blind, placebo-controlled trials (Pivot RLS I and Pivot RLS II), which evaluated the safety and efficacy of Solzira over 12 weeks.
The submission has also included results from a third pivotal trial (Pivot RLS Maintenance) evaluating the ability of Solzira to maintain efficacy in treating RLS symptoms over a nine-month period.
According to the company, Solzira is a non-dopaminergic new chemical entity that provides improvement in the symptoms of RLS with the convenience of a once-daily formulation.
Ronald Barrett, CEO of XenoPort, said: “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.”