GSK/XenoPort submit NDA for Solzira

UK drug major GlaxoSmithKline and USA-based Xenoport have submitted a New Drug Application to the US Food and Drug Administration requesting approval of Solzira (gabapentin enacarbil) extended-release tablets for the treatment of moderate-to-severe primary restless legs syndrome, a condition that affects an estimated 12 million people in the USA. Solzira is a non-dopaminergic New Chemical Entity that provides improvement in the symptoms of RLS with the convenience of a once-daily formulation. The submission is based on a Phase III clinical development program for Solzira in patients with moderate-to-severe primary RLS, including data from two randomized, double-blind, placebo-controlled trials that evaluated the safety and efficacy of Solzira over 12 weeks. On the day of the news, September 16, shares in Xenoport rose 3.4% to $49.90.