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news.UCB has reported that the supplemental new drug application for the use of Neupro as a treatment for moderate-to-severe restless legs syndrome has been accepted for filing by the FDA.
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The submission is based on 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 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.
Neupro is a once-daily patch designed to provide continuous drug delivery over a 24 hour period. In July 2007 Neupro was launched in the US for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease.
Arthur Walters, study investigator, said: “These study results showed that rotigotine significantly improved symptoms of restless legs syndrome throughout the six-month trial period.”