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 Restless Legs Syndrome (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.
Neupro is already approved in Europe and the US 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. Neupro is a once-daily patch designed to provide continuous drug delivery over a 24 hour period.
Troy Cox, president CNS Operations, UCB, said: “This new filing for Neupro reflects UCB’s commitment to finding innovative medicines for conditions where there is a continuing need for alternative treatment.”