Date: 2012-04-11
Type of information:
Product name: Neupro®
Compound: (rotigotine transdermal system)
Therapeutic area:
Action mechanism: As a Parkinson\'s disease 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 Restless Legs Syndrome, 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.
Company: UCB (Belgium)
Disease: Parkinson’s Disease
Restless Legs Syndrome
Latest news: * On April 3, 2012, UCB announced that the 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. The FDA has also approved UCB’s new formulation of Neupro®.
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 medications 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 progress in RLS symptoms on a 7-point scale.
In clinical trials, the most common adverse reactions (?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 (?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.
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Submission of marketing authorization application UE:
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Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
