Rotigotine transdermal patch (
Neupro(®)) [referred to here as
rotigotine] is a non-ergolinic
dopamine agonist that is available in the EU as monotherapy for the treatment of early
Parkinson's disease and as combination
therapy with
levodopa throughout the course of the disease. Daily application of the
rotigotine patch provided predictable release and absorption of
rotigotine, with steady-state
rotigotine concentrations reached within 1-2 days. In early
Parkinson's disease, compared with placebo,
rotigotine monotherapy produced significantly greater improvements in the Unified Parkinson's Disease Rating Scale summed motor and
activities of daily living (
ADL) scores (primary endpoint), as well as significantly higher response rates. In advanced
Parkinson's disease,
rotigotine in combination with
levodopa reduced 'off' time (primary endpoint) and improved motor functioning and
ADL significantly more than
levodopa plus placebo. In patients with inadequate early morning motor control despite antiparkinsonian treatment,
rotigotine improved morning motor functioning and reduced sleep disturbances, night-time motor symptoms, depressive symptoms,
pain and functioning, and quality of life to a significantly greater extent than placebo. The efficacy of
rotigotine relative to other treatments requires further evaluation, as there were inconsistent results in noninferiority analyses that compared
rotigotine to other
dopamine agonists.
Rotigotine was generally well tolerated across the trials, with the most common treatment-emergent adverse events being application-site reactions, gastrointestinal disturbances,
somnolence and
headache. No unexpected adverse effects were observed in extension studies of up to 6 years. Thus,
rotigotine offers a novel approach to the treatment of
Parkinson's disease and, given its ease of administration, efficacy in reducing disabling motor and non-motor symptoms, and acceptable tolerability profile, it has the potential to be an attractive treatment option for this highly debilitating disease.