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Post Hoc Analysis from RECOVER Study Examined Effects of Neupro® (Rotigotine Transdermal System) on Surrogate Markers of Mood and Anhedonia in Parkinson's Disease
Date:6/9/2011

eatment, and rotigotine transdermal system was generally well tolerated.

The most common treatment-emergent adverse events (TEAEs) during the open label phase (n=84) were application and instillation site reactions (24%), somnolence and hallucination (13% each) and nausea and fall (12% each). Most were mild or moderate in intensity and had resolved at the end of the trial. 13% of subjects withdrew due to a TEAE, most common were application site reactions (6.0%) and peripheral oedema (2.4%).

The RECOVER study was a double-blind, placebo-controlled trial (n=287) that reported significant benefits with rotigotine transdermal system for both early morning motor function (Unified Parkinson's Disease Rating Scale; UPDRS  Part III) and nocturnal sleep disturbances (Parkinson's Disease Sleep Scale; PDSS-2) compared with placebo (p=0.0002 and p<0.0001, respectively).

About Neupro® in the European Union

Neupro® (rotigotine) is approved in the European Union for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease, as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occurs. Neupro® is also approved in the European Union for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adults.

Neupro® in the European Union Important Safety Information

Neupro® is contraindicated in case of hypersensitivity to the active substance or to any of its excipients, and in case of magnetic resonance imaging (MRI) or cardioversion. Neupro® should be removed if the patient has to undergo MRI or cardioversion.

It is recommended to monitor blood pressu
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SOURCE UCB
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