A supplementary New Drug Application (sNDA) for Neupro® (rotigotine transdermal system) as a treatment for moderate to severe restless legs syndrome (RLS) has been accepted for filing by the FDA.
Neupro, produced by Belgian biopharma firm UCB, is a once-daily patch designed to provide continuous drug delivery over a 24-hour period.
RLS is a chronic neurological disorder that affects 3-10% of the population.
Troy Cox, president of CNS operations at UCB, said: “The acceptance of the sNDA underscores our ongoing commitment to provide innovative therapies for patients living with debilitating central nervous system disorders.”
The submission is based on two fixed-dose, randomised, 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.
Rotigotine study investigator Professor Arthur Walters said: “This chronic condition can be serious and even debilitating with many patients requiring treatment that offers sustained symptom control,”
“These study results showed that rotigotine significantly improved symptoms of restless legs syndrome throughout the six-month trial period,” said Professor Walters, of Seton Hall University, USA.
In July 2007 Neupro was launched in the USA for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease.
In Europe, Neupro is indicated for treating the signs and symptoms of early-stage idiopathic Parkinson’s disease as monotherapy and as adjunctive therapy with levodopa in advanced-stage Parkinson’s disease.
RLS is characterised by unpleasant feelings in the legs and an irresistible urge to move in order to relieve the discomfort.
RLS sensations are frequently described as tingling, burning, tugging, gnawing and pulling.
The exact cause of RLS is not known, but recent clinical research has linked certain genes to RLS, suggesting that the disorder is biologically based.
Symptoms of RLS typically appear during periods of rest and inactivity, particularly in the evenings and at night.
This can make it difficult to fall asleep and stay asleep, thus preventing recuperative sleep and often leading to daytime fatigue and reduced alertness.
While RLS symptoms are generally most pronounced in the evening and while at rest, other periods of inactivity, such as long flights, car trips and sitting in a cinema can also trigger symptoms.