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news.UCB has revealed results from a 5-year prospective open-label restless legs syndrome (RLS) study of Neupro (rotigotine), which showed continued symptomatic clinical benefit with a low risk of augmentation.
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In the trial, the patients were titrated to an optimal dose of rotigotine (0.5-4.0 T mg/24h) and periodically evaluated for safety and efficacy. Of the 295 patients in the study, 126 completed the 5-year follow-up.
According to the trial, 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.
Rotigotine showed an improvement in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) score from 27.8±5.9 at baseline to 9.0±9.2 after 5 years.
Sleep Research Institute in Madrid director and lead investigator Diego Garcia-Borreguero said the study findings support rotigotine as a long-term treatment option and improve their understanding of the clinical relevance of augmentation and its progressive course in studies greater than one year.
Neupro is approved in the European Union for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adults.
It is also approved in the European Union for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease, as monotherapy (without levodopa) or in combination with levodopa.
Neupro (rotigotine transdermal system) is indicated in the US for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease.