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Neupro(R) Filed with the FDA for the Treatment of Advanced-Stage Parkinson's Disease
Date:12/13/2007

The U.S. Food and Drug Administration (FDA) has accepted for filing the

Supplemental New Drug Application (sNDA) for the use of Neupro(R) (Rotigotine Transdermal System) as adjunctive therapy with levodopa in

adult patients with advanced-stage Parkinson's disease

ATLANTA, Dec. 13 /PRNewswire/ -- UCB announced today that the supplemental New Drug Application (sNDA) for the use of Neupro(R) as adjunctive therapy with levodopa in adult patients with advanced-stage Parkinson's disease has been accepted for filing by the U.S. Food and Drug Administration (FDA).

The FDA has already approved Neupro(R) for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease and the drug has been commercially available in the United States since July 2007.

"We are excited that patients with all stages of Parkinson's disease may soon benefit from Neupro(R)'s 24-hour continuous drug delivery," said Troy Cox, President CNS Operations, UCB.

The sNDA is based on efficacy and safety data in more than 670 patients with advanced-stage Parkinson's disease who were treated with rotigotine in three double-blind, placebo-controlled clinical trials. These studies demonstrated that rotigotine, as adjunctive therapy to levodopa in patients with advanced-stage Parkinson's disease, showed clinically relevant reductions in "off" time (periods where the effectiveness of medications wear off and Parkinson's symptoms return) and favorable increases in "on" time without troublesome dyskinesia (fragmented or jerky movements). The most frequently-reported adverse events in rotigotine clinical trials included application site reactions, nausea, vomiting, dizziness, somnolence and dyskinesia.

"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. Once-daily dosing may improve compl
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SOURCE UCB
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