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Experimental Rotigotine Patch for Parkinson's Disease Safe, Effective and Tolerated for 85 Weeks: Presented at ANA By Ed Susman CHICAGO, IL -- October 11, 2006 -- A once-daily patch of the investigative drug rotigotine allows Parkinson's patients to remain in control of their illness for at least 85 weeks, according to research presented here at the American Neurological Association (ANA) 131st Annual Meeting. The year-long extension of a 6-month study in which treatment with the patches proved significantly more efficacious than placebo, included 216 patients, 79 of whom were switched to the patch after being on placebo medication in the first study. Ray Watts, MD, chairman, department of neurology, University of Alabama, Birmingham, Alabama, said that in the first study, treatment with the 24-hour patches resulted in a decrease of 7 points in the Unified Parkinson's Disease Rating Scale almost immediately after the start of the trial. After 6 months, the score decreased by 4 points. Patients on placebo began the study with a drop of 4 points but by the end of 6 months were about 2 points higher than baseline. "In Parkinson's disease, we expect to see a 3-point yearly increase in the UPDRS, so an overall drop of 4 points is very good news," Dr. Watts said at his poster presentation October 10th. The comparative increase in the UPDRS among the placebo patients produced a difference of about 6 points, a difference that reached statistical significance at the P < .0001 level, he said. After completion of the 6-month phase, patients in the placebo arm were invited to remain in the extension phase of the study, when they were switched to active treatment. In these patients, scores decreased immediately by about 7 points during the titration period from a patch containing 2 mg per day of rotigotine to patches containing 6 mg in a year, reaching the level of the patients who had started on rotigotine. After 85 weeks, patients who started on rotigotine were still about 2 points below baseline; those who were switched to the patch after 6 months were about 2 points above baseline. "The rotigotine transdermal patch was generally safe and well tolerated with a low rate of discontinuance due to adverse effects," Dr. Watts said. "We think that use of the patch can help a person with early stage Parkinson's disease hold off on use of levodopa for 2 to 3 years." The studies were sponsored b y Schwarz Pharma, based in Monheim, Germany. The drug is expected on the US market in 2007. It is currently being reviewed by the US Food and Drug Administration. [Presentation title: Long-Term Safety and Efficacy of the Rotigotine Transdermal Patch in Early-Stage Parkinson's Disease. Abstract T-47] ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn