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Schwarz Pharma Presented Phase III Data in Early Parkinson's Disease
- Jun 23 2004
Pivotal Phase III data on Rotigotine, the Parkinson Patch, presented at the 8th International Congress of Parkinson's Disease and Movement Disorders, June 13 - June 17, 2004, Rome, Italy.
The results of a multinational, randomized, placebo-controlled phase III trial to investigate efficacy, tolerability and safety of rotigotine in patients with early stage Parkinson's disease have been presented at the MDS-Conference in Rome, Italy. Rotigotine CDS is a novel dopamine receptor-agonist for the treatment of Parkinson's disease formulated as a continuous delivery system, a patch. This silicone-based patch is applied once a day and administrates rotigotine transdermally to the body. Results demonstrated that rotigotine significantly reduced symptoms of Parkinson's disease. The observed treatment effect over placebo was statistically significant and clinically relevant. Stable plasma levels were demonstrated during the treatment period with once-daily administration of rotigotine. Rotigotine treatment was well tolerated.
"This study demonstrates that rotigotine can successfully improve the disease symptoms," says Doctor Ray Watts, Professor & Chairman Department of Neurology, University of Alabama (Birmingham), USA and signatory investigator of the phase III trial. "This drug in development provides a strong clinical benefit and the transdermal approach may offer a needed alternative for Parkinson's disease patients unable to take oral medications."
"In three consecutive trials rotigotine treatment resulted in a clinically relevant superiority over placebo", Professor Iris Loew-Friedrich, MD, PhD, Member of the Executive Board of Schwarz Pharma, says. "After a 24-week maintenance period, rotigotine has shown a significant reduction in symptoms whereas the disease signs increased with placebo. With more than 95% of the completers from the Phase III trial continued into an open-label extension trial, rotigotine appears to offer patients a well-accepted treatment option. We are looking forward to submitting applications for market approval for the Parkinson Patch in the third quarter of 2004."
In this multi-center double-blind, dose-escalation trial 277 patients with early-stage, idiopathic Parkinson's disease (Hoehn & Yahr stage =3) had been randomized. Patients were titrated up to 7.2 mg/24h with a maintenance period of 6 months. The maximum treatment exposure was 7 months. The primary variable was the average reduction of symptoms by rotigotine compared to placebo). This was measured by the UPDRS and the responder rate. UPDRS, the Unified Parkinson's Disease Rating Scale, is a standardized measure of patients' abilities to perform basic motor skills, as well as activities of daily living and mental abilities. Rotigotine resulted in a significant improvement in the absolute UPDRS (Parts II and III) subtotal score at the end of the treatment (approximately 5.3 points difference from placebo). The proportion of responders was significantly higher at the end of the treatment compared with placebo (48% vs. 19%).
The most frequent adverse events to Rotigotine were: Application site reaction, somnolence, dizziness, fall, nausea, headache and vomiting. Adverse events due to hallucination, confusion, and hypotension either did not occur or occurred at rates similar to placebo.
Source Date: Jun 23 2004
Source Publication: Schwarz Pharma