Breaking News
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

UCB Says FDA Okays Neupro For Parkinson's Disease, Restless Legs Syndrome

4/3/2012 1:38 AM ET

Biopharmaceutical firm UCB SA (UCB: Quote) 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.

Register
To receive FREE breaking news email alerts for UCB SA and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Justin Moore has been named Humanitarian of the Year by by the Armed Forces Foundation. Moore received the award alongside Big Machine Label Group President/CEO Scott Borchetta for their service and commitment to the morale and welfare of military families through the Crown Royal "Your Hero's Name Here" contest. International Business Machines Corp. said Wednesday after the markets closed that its first quarter profit fell 21% from last year, hurt by lower revenue as well as a hefty workforce rebalancing charge. The company's quarterly earnings per share, excluding items, came in line with analysts' expectations, but its quarterly revenue fell short of analysts' forecast. Stocks moved sharply higher over the course of the trading day on Wednesday, further offsetting the steep losses posted late last week. The markets benefited from a positive reaction to the latest earnings news as well as remarks by Federal Reserve Chairman Janet Yellen. The major averages saw further upside going into the close, ending the session at their best levels of the day.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.