Rotigotine transdermal delivery for the treatment of restless legs syndrome.

IMPORTANCE OF THE FIELD: Rotigotine is a non-ergot dopamine agonist devised to be applied transdermally as a patch. It is currently licensed for treatment of early (USA and Europe) and advanced (Europe) Parkinson's disease, as well as for the treatment of moderate to severe restless legs syndrome (RLS) (Europe). Constant drug delivery and ease of use due to the application of an adhesive patch once daily are the potential advantages of the rotigotine patch for the treatment of RLS.

AREAS COVERED IN THIS REVIEW: The evidence on the efficacy, tolerability and safety of rotigotine in the treatment of RLS is reviewed. Source material was identified using a PubMed search using the key words 'rotigotine' (up to September 2009) and using data from rotigotine trials being submitted or published in abstract form. This review focuses only on publications related to rotigotine for the treatment of RLS.

WHAT THE READER WILL GAIN: In the drug trials summarized here, rotigotine transdermal patch is efficacious for the treatment of RLS, using dosages between 1 and 3 mg/24 h, up to 30% of severely affected patients reached freedom of symptoms with an IRLS (International Restless Legs Syndrome Severity Scale) of zero. Safety and tolerability are similar to other non-ergot dopamine agonists, except for application site reactions, which may limit practicability. Retrospective analysis of augmentation were 1.5% in placebo-controlled 6-month trials and 2.9% in a 1-year open trial.

TAKE HOME MESSAGE: The rotigotine transdermal patch can provide 'around the clock' treatment for moderate to severe RLS. Further comparative studies need to clarify whether continuous low-dose dopamine-agonist therapy will have any influence on augmentation rates.