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 FDA has already approved Neupro 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.
Troy Cox, president of CNS Operations, UCB, said: “We are excited that patients with all stages of Parkinson’s disease may soon benefit from Neupro’s 24-hour continuous drug delivery.”