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New Data Show Low Incidence of Augmentation of Restless Legs Syndrome With 5-Year Neupro® (rotigotine) Treatment
Date:4/14/2011

BRUSSELS, April 14, 2011 /PRNewswire/ -- New 5-year data from the longest prospective open-label Restless Legs Syndrome (RLS) study to date, show that Neupro® (rotigotine) demonstrated continued symptomatic clinical benefit with a low risk of augmentation. Over the five year period, clinically significant augmentation occurred in 5.1% of patients receiving rotigotine at EU approved doses (1, 2 and 3 mg/24h) and in 13.2% of patients receiving one of the five evaluated doses of rotigotine (0.5 *, 1, 2, 3 and 4.0 * mg/24h).

The study, presented at the 63rd Annual Meeting of the American Academy of Neurology (AAN) Hawaii, U.S., also reported that the frequency of newly diagnosed augmentation decreased over time, but that the new cases of augmentation were more likely to be clinically significant after the first year.

Augmentation is a recognized complication of dopaminergic treatment of RLS. Augmentation is characterized by an earlier onset of symptoms, an extension of symptoms to other body parts, an increased symptom intensity and/or shorter duration of relief from treatment. To date, no data were available on the long term use of the dopamine agonist therapeutic class for the treatment of moderate to severe RLS patients.

"In this study, the longest prospective RLS study to date, rotigotine was associated with a low 5-year incidence of clinically significant augmentation, with the occurrence of new cases decreasing over time," commented Dr. Diego Garcia-Borreguero, lead investigator and Director of the Sleep Research Institute, Madrid, Spain. "These study findings support rotigotine as a long-term treatment option and improve our understanding of the clinical relevance of augmentation and its progressive course in studies greater than one year."

This study was a 5-year, prospective, open-label follow up of a placebo-controlled Phase II trial with rotigotine.  Patients were titrated to an optimal dose of rotigotine (0.5-4.0 *
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