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BRUSSELS and ATLANTA, April 3, 2012 /PRNewswire/ -- UCB announced today that the U.S. Food and Drug Administration (FDA) approved Neupro (rotigotine transdermal system) for the treatment of the signs and symptoms of advanced stage idiopathic Parkinson's disease (PD) and as a treatment for moderate-to-severe primary Restless Legs Syndrome (RLS). Neupro was previously approved by the FDA for the signs and symptoms of early stage idiopathic PD. Neupro is a dopamine agonist patch that provides continuous drug delivery for patients with PD and RLS. The FDA has also approved UCB's new formulation of Neupro.
"Neupro represents an innovation in the treatment of Parkinson's disease and restless legs syndrome," said Prof. Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President of Global Projects and Development at UCB. "UCB is thrilled to make Neupro available to patients living with these serious diseases."
"RLS can be a serious condition with symptoms that affect patients during the day as well as at night; and Parkinson's disease symptoms can have a broad impact on patients. Neupro provides a novel way of treating RLS and PD through continuous transdermal dopaminergic delivery. It can help patients manage the unpredictable nature of these chronic conditions," said William Ondo, M.D., Professor, Department of Neurology, University of Texas Health Science Center at Houston.
As a PD treatment, the mechanism of action of Neupro is thought to be related to its ability to stimulate dopamine receptors within the caudate-putamen, the region of the brain that regulates movement. Similarly, in RLS, the mechanism of action of Neupro may be related to its ability to stimulate dopamine receptors. The precise mechanism of action of Neupro as a treatment for these diseases is unknown.
Data Demonstrated Significant Symptom Improvement for PD and RLS
The effectiveness of Neupro in the treatment of the signs and symptoms of idiopathic PD was established in five parallel group, randomized, double-blind placebo-controlled trials conducted in the U.S. and abroad. Depending on trial design, patients underwent a weekly titration of Neupro in 2 mg/24 hours increments to either the randomized dose or optimal dose.
In three trials, statistically significant improvements in the combined scores on the Unified Parkinson's Disease Rating Scale (UPDRS) were observed in early stage PD patients receiving Neupro compared with patients receiving placebo. The UPDRS is a multi-item rating scale intended to evaluate mentation, activities of daily living (ADL), motor performance, and complications of therapy. The three trials measured only the ADL and motor performance sections of the UPDRS. The UPDRS contains 13 questions relating to ADL, such as speech, dressing, and cutting food with utensils, and 27 questions related to the cardinal motor symptoms in PD patients—i.e., tremor, rigidity, bradykinesia, and postural instability.
Two trials of Neupro in patients with advanced PD examined change from baseline in "off" time, periods when the effectiveness of medication wears off and PD symptoms return. Statistically significant changes in off-times were observed in advanced PD patients receiving Neupro compared with those who received placebo.
The efficacy of Neupro in the treatment of RLS was primarily evaluated in two fixed-dose, randomized, double-blind, placebo-controlled trials with six-month maintenance periods. Patients received Neupro doses ranging from 0.5 mg/24 hours to 3 mg/24 hours, or placebo, once daily.
Statistically significant improvements in sum scores on the International RLS Rating Scale (IRLS Scale) and the Clinical Global Impression - Improvement (CGI-I) assessment were observed in RLS patients receiving Neupro compared with those receiving placebo. The IRLS Scale contains 10 items designed to assess the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence, and impact on activities of daily living and mood associated with RLS. The CGI-I is designed to clinically assess RLS symptoms on a 7-point scale.
In clinical trials, the most common adverse reactions (greater than or equal to 5% greater than placebo) for the highest recommended doses of Neupro for treatment of Parkinson's disease were nausea, vomiting, somnolence, application site reactions, dizziness, anorexia, hyperhidrosis, and insomnia. The most common adverse reactions (greater than or equal to 5% greater than placebo) for the highest recommended dose of Neupro for treatment of Restless Legs Syndrome were application site reactions, nausea, somnolence, and headache.