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Positive Trial Results for Rotigotine Patch 'Neupro' in Advanced Parkinson's Disease
- Oct 12 2004
Schwarz Pharma announced today that the response of patients with advanced stage of Parkinson's disease treated with NeuproTM (rotigotine transdermal system) as adjunctive therapy showed statistically significant and clinically relevant reduction in 'off' time without an increase in undesirable dyskinesias.
Results of the study showed that both primary endpoints for the U.S. and Europe were achieved and the product appeared to be well tolerated. Ninety-nine percent of patients who completed the trial continued on NeuproTM in an open-label extension trial.
In this U.S. phase III trial 351 patients with advanced stage idiopathic Parkinson's disease were randomized. This double-blind, placebo controlled trial had a 5-week titration phase and a 24-week maintenance phase. NeuproTM was added to stable levodopa treatment. The primary parameters were change from baseline in the absolute 'off' time and response rate. Response was defined as a decrease in absolute 'off' time from baseline by at least 30%. The most common adverse events associated with the use of rotigotine transdermal system are application site reactions, somnolence, nausea and dizziness. These were not unexpected and are commonly seen with dopamine agonists and transdermal delivery systems.
"This trial demonstrates that 'Neupro' in adjunctive therapy with patients with advanced stage Parkinson's disease can be efficacious, tolerable and safe," said Iris Loew-Friedrich, MD, PhD, Member of the Executive Board Schwarz Pharma AG. "We are encouraged by the good news from our Parkinson's programs. End of September we submitted a NDA and a MAA for Neupro to treat patients in early stages of Parkinson's disease."
The European phase III trial with NeuproTM as adjunctive therapy in patients with advanced stage Parkinson's disease started in the second quarter of 2004. Four hundred and seventy patients are planned for this double-blind, placebo and active comparator controlled trial. Results are expected early 2006.
Source Date: Oct 12 2004