Neupro Filed in Europe for the Treatment of Restless Legs Syndrome

07-Dec-2007

UCB announced that the application for marketing authorization for the use of Neupro® in the treatment of moderate-to-severe restless legs syndrome (RLS) has been accepted for filing by the European Medicines Agency (EMEA). Neupro® is a once-daily patch designed to provide continuous drug delivery over a 24 hour period. Restless Legs Syndrome is a chronic neurological disorder that affects between three and ten per cent of the population.

"This new filing for Neupro® reflects UCB's commitment to finding innovative medicines for conditions where there is a continuing need for alternative treatment," commented Troy Cox, President CNS Operations, UCB.

The filing is based on the results of two fixed-dose, randomized, double-blind, placebo-controlled efficacy and safety studies that evaluated rotigotine for the treatment of moderate-to-severe idiopathic RLS in approximately 1,000 patients over six months. In these trials, rotigotine produced statistically significant reductions in RLS symptoms compared to placebo and was generally well-tolerated. The efficacy of rotigotine was evaluated by monitoring the International Restless Legs Severity Scale (IRLS), a clinician-administered tool considered to be the best scale for evaluating the severity and frequency of RLS symptoms and the degree to which they affect sleep and daily life. The most frequently reported adverse events associated with rotigotine in these studies were application site reactions, nausea, dizziness, somnolence and headache.

Neupro® is already approved in Europe and the U.S. for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's Disease as monotherapy and in Europe as adjunctive therapy with levodopa for advanced-stage Parkinson's disease.

https://www.bionity.com/en/news/75510/neupro-filed-in-europe-for-the-treatment-of-restless-legs-syndrome.html