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Title: Rotigotine Transdermal Patch Safe in Early-Stage Parkinson's Disease: Presented at ANA

"Rotigotine Transdermal Patch Safe in Early-Stage Parkinson's Disease: Presented at ANA"

By Maggie Schwarz WASHINGTON, DC -- October 9, 2007 -- Use of a rotigotine transdermal patch appears to be well tolerated after nearly 3 years, according to results from a 33-month interim analysis of a 4-year study presented here at the 132nd Annual Meeting of the American Neurological Association (ANA). Rajesh Pahwa, MD, Director, Parkinson's Disease and Movement Disorder Center, and Laverne and Joyce Rider Professor of Neurology, University of Kansas School of Medicine, Kansas City, Kansas, United States, presented the study. The rotigotine patch is approved in Europe for both early- and advanced-stage idiopathic Parkinson's disease (2-16 mg/24 h) and has been approved in the US for early-stage Parkinson's disease (at least 6 mg/24 h). Once-daily administration of the patch delivers rotigotine continuously over a 24-hour period. After de-escalation from blinded treatment, open-label rotigotine was titrated in 2 mg/24 hour weekly increments to a maximum dose of 6 mg/24 hour (30 cm[² patch during the first year. Dose adjustments were allowed throughout the trial; after 1 year of open-label therapy (at least 16 mg/24 h). Concomitant levodopa therapy was permitted, if needed, after 1 month of maintenance therapy with rotigotine.

The safety assessment included treatment-emergent adverse events (AEs), vital signs, laboratory parameters and electrocardiograms. Other outcomes included assessments of dyskinesia and efficacy.

Of the 223 eligible patients completing double-blind treatment, 216 (97%) elected to enrol in the open-label extension. Most patients (89%) were titrated to 6 mg/24 h, the maximum allowable dose per protocol on entering the first year of open-label maintenance. At the 30-month visit, the mean rotigotine dose was 6.58 mg/24 h. At the 33-month cut-off for the current analysis, 47% of subjects were receiving adjunctive levodopa.

The rotigotine transdermal patch was generally well tolerated, with a low rate of discontinuation due to AEs (13%). The majority of AEs that led to trial discontinuation occurred during the first 16 weeks of open-label treatment. Overall, the most common AEs in the open-label study were somnolence, application site reactions (ASRs), nausea, and dizziness. Most ASRs were rated as mild in severity and accounted for seven of the 26 treatment-emergent adverse event-related discontinuations.

In the open-label trial, six of 79 patients (8%) in the placebo group and eight of 137 (6%) in the rotigotine group developed dyskinesia during the double-blind phase. Of the 14 patients who developed dyskinesia during the open-label trial, all but three did so following introduction of adjunctive levodopa (mean dose, 402 mg daily). In addition, 1.4% of patients developed dyskinesia in the rotigotine group.

Among patients who took placebo during the double-blind portion of the trial, the Unified Parkinson's Disease Rating Scale (UPDRS) score improved markedly once they initiated open-label rotigotine. Patients who were initially treated with rotigotine regained their previous level of improvement on retitration.

Patients who were originally randomised to rotigotine treatment in the double-blind phase maintained a group mean UPDRS score below baseline throughout both the double-blind and 30 months of open-label maintenance treatment.

Dr. Pahwa concluded that it is reassuring to know that the rotigotine patch, which has been demonstrated to be effective, is well tolerated in long-term therapy.

[Presentation title: Long-Term Safety of Rotigotine Transdermal Patch in Early-Stage Parkinson's Disease. Abstract S-24]

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