Neupro's manufacturer, UCB, has recently submitted a supplemental application to the U.S. Food and Drug Administration (FDA) requesting approval to market the dopamine agonist patch as add-on therapy with levodopa in adult patients with advanced-stage Parkinson's disease.
The FDA has already approved Neupro for treating early-stage Parkinson's disease and the drug has been commercially available in the United States since July 2007.
Even when a drug is already approved by the FDA, its manufacturer must submit a suplemental new drug application (sNDA) for any new uses of the drug.
"As these clinical studies have shown, continuous delivery of rotigotine in a transdermal form can improve control of 'off' time in advanced-stage Parkinson's patients throughout the day and night," said Peter A. LeWitt, M.D., professor of neurology at the Wayne State School of Medicine, and director of the Parkinson's Disease and Movement Disorders Program at the Henry Ford Hospital in Southfield, Michigan. "Once-daily dosing may improve compliance over medications that require several daily doses."
The sNDA is based on effectiveness and safety data in more than 670 patients with advanced-stage Parkinson's disease who were treated with rotigotine in three clinical trials. These studies demonstrated that rotigotine, as add-on therapy to levodopa in patients with advanced-stage Parkinson's disease, showed clinically relevant reductions in "off" time and favorable increases in "on" time without troublesome dyskinesia. The most frequently-reported adverse events in rotigotine clinical trials included application site reactions, nausea, vomiting, dizziness, somnolence, and dyskinesia.
Source:
UCB press release