UCB announced today that FDA has approved a new formulation of rotigotine transdermal system for the treatment of the signs and symptoms of advanced stage idiopathic Parkinson disease and as a treatment for moderate to severe primary restless legs syndrome (RLS). The original formulation, which was only approved to treat the signs and symptoms of early-stage idiopathic Parkinson disease, was recalled in 2008 because of the formation of rotigotine crystals in the patches.

FDA's most recent approval was based on data from seven trials. For management of the signs and symptoms of idiopathic Parkinson disease, the efficacy of rotigotine transdermal system was established in five parallel-group, randomized, double-blind, placebo-controlled trials. In three trials, statistically significant improvements in combined scores on the Unified Parkinson Disease Rating Scale were observed in patients with early-stage Parkinson disease who were receiving rotigotine transdermal system compared with patients receiving placebo. In two trials in patients with advanced Parkinson disease, significant changes in off-times were observed in patients receiving active therapy compared with those who received placebo.

The product's efficacy in the treatment of primary RLS was established in two fixed-dose, randomized, double-blind, placebo-controlled trials with 6-month maintenance periods. Patients received rotigotine doses ranging from 0.5 mg/24 h to 3 mg/24 h once daily. Significant improvements in sum scores on the International RLS Rating Scale and the Clinical Global Impression–Improvement Assessment were observed in patients receiving active drug compared with those receiving placebo.

UCB reported that rotigotine transdermal system will be available in July 2012.