Biopharmaceutical firm UCB SA (UCB) on Tuesday said the U.S. Food and Drug Administration approved Neupro (Rotigotine Transdermal System) for the treatment of the signs and symptoms of advanced stage idiopathic Parkinson's disease, or PD, and as a treatment for moderate-to-severe primary Restless Legs Syndrome, or RLS.
Neupro is a dopamine agonist patch that provides continuous drug delivery for patients with PD and RLS. It 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.
William Ondo, Professor, Department of Neurology, University of Texas Health Science Center, said, "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."
The effectiveness of Neupro in treating the signs and symptoms of idiopathic PD was established in five parallel group, randomized, double-blind placebo-controlled trials. 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, or UPDRS, were observed in early stage PD patients receiving Neupro compared with patients receiving placebo.
Two trials of Neupro in patients with advanced PD examined change from baseline during so called off times or 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 and the Clinical Global Impression - Improvement assessment were observed in RLS patients receiving Neupro compared with those receiving placebo.
The precise mechanism of action of Neupro as a treatment for these diseases is unknown. As a PD treatment, Neupro's action is thought to be related to its ability to stimulate dopamine receptors within the caudate-putamen, the region of the brain that regulates movement.
In RLS, the mechanism of action of Neupro may be related to its ability to stimulate dopamine receptors.
Neupro will be available in U.S. retail pharmacies in July.
The stock closed in Brussels on Monday higher by 4.57 percent at 33.83 euros on a volume of 587,010 shares.
by RTT Staff Writer
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