Neupro(R) Filed with the FDA for the Treatment of Restless Leg...( The U.S. Food and Drug Administrati...),Health

The U.S. Food and Drug Administration (FDA) has accepted for filing the

Supplemental New Drug Application (sNDA) for the use of Neupro(R) (Rotigotine Transdermal System) as a treatment for moderate-to-severe

restless legs syndrome (RLS)

ATLANTA, Dec. 13 /PRNewswire/ -- UCB announced today that the supplemental New Drug Application (sNDA) for the use of Neupro(R) 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). Neupro(R) is a patch designed to provide continuous drug delivery. Restless legs syndrome is a chronic neurological disorder that affects between three and ten percent of the population.

"The acceptance of the sNDA underscores our ongoing commitment to provide innovative therapies for patients living with debilitating central nervous system disorders," said Troy Cox, President CNS Operations, UCB.

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 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. The most frequently reported adverse events associated with rotigotine in these studies were application site reactions, nausea, dizziness, somnolence and headache.

"This chronic condition can be serious and even debilitating with many patients requiring treatment that offers sustained symptom control," said rotigotine study investigator Arthur S. Walters, MD,
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