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news.German firm Schwarz Pharma has said phase III data shows that rotigotine provided a statistically significant and clinically relevant reduction in "off" time for Parkinson's disease patients.
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The trial was designed to assess efficacy and safety with two doses of rotigotine, a dopamine agonist formulated as a patch for once-daily administration, in subjects with advanced Parkinson’s disease. The primary efficacy variable was change from baseline in the absolute “off” time or periods where the effectiveness of medications wear off and Parkinson’s disease symptoms return.
Schwarz Pharma’s rotigotine also showed an increase in “on” time without dyskinesia, which is characterised by involuntary movement. The average decrease of 2.4 hours in daily “off” time with rotigotine exceeded the 0.9 hour decrease in the placebo group. The differences between both rotigotine dose arms and placebo were statistically significant.
Peter LeWitt, head of the Clinical Neuroscience Center in Southfield, Michigan, stated: “Many advanced-stage Parkinson’s disease patients experience multiple daily increases in Parkinsonian symptoms between each dose of medication. By providing continuous drug delivery, this study demonstrated that the rotigotine patch can greatly improve the consistency of Parkinson’s disease symptom control throughout the day.”
Rotigotine is currently under review with the FDA for its efficacy and safety as treatment for early-stage Parkinson’s disease.