UCB : Neupro recommended for approval in Europe for Restless Legs Syndrome

25 April, 2008 - UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending that the European Commission grants a marketing authorisation for Neupro® (rotigotine transdermal patch) in the symptomatic treatment of moderate-to-severe idiopathic Restless Legs Syndrome (RLS) in adults.
The CHMP decision is based on data from two well-controlled clinical trials that evaluated the efficacy and safety of Neupro® over a six month period in almost 1,000 patients with RLS. In these trials, Neupro® showed significant and clinically relevant improvements in RLS symptoms compared to placebo and was generally well tolerated... UCB's Press Release -

UCB's Neupro, Filed with the FDA for the Treatment of Restless Legs Syndrome

December 12, 2007 - UCB announced that the supplemental New Drug Application (sNDA) for the use of Neupro as a treatment for moderate-to-severe restless legs syndrome (RLS) has been accepted for filing by the U.S. Food and Drug Administration (FDA)...Restless Legs Syndrome is a chronic neurological disorder that affects between three and ten per cent of the population...Symptoms of RLS typically appear during periods of rest and inactivity, particularly in the evenings and at night. This can make it difficult to fall asleep and stay asleep, thus preventing recuperative sleep and often leading to daytime fatigue and reduced alertness... UCB's Press Release -