Belgium’s UCB says that its application for marketing authorisation for the use of its Parkinson’s disease drug Neupro in the treatment of moderate-to-severe Restless Legs Syndrome has been accepted for filing by the European Medicines Agency.
Neupro (rotigotine), is a once-daily patch designed to provide continuous drug delivery over a 24-hour period, the Brussels-based company noted, adding that RLS is a chronic neurological disorder that affects between 3%-10% of the population.
The filing is based on the results of two studies that evaluated rotigotine for the treatment of moderate-to-severe idiopathic RLS in approximately 1,000 patients over six months. Those trials showed that Neupro produced statistically significant reductions in RLS symptoms compared to placebo and was generally well-tolerated. The most frequently reported adverse events were application site reactions, nausea, dizziness, somnolence and headache.
Neupro is already approved in Europe and the USA for the treatment of early-stage idiopathic Parkinson’s Disease as monotherapy and in Europe as adjunctive therapy with levodopa for patients suffering from advanced stages of the condition.
Other RLS treatments include GlaxoSmithKline’s Requip (ropinirole) and Boehringer Ingelheim’s pramipexole.
