Rotigotine transdermal patch: in restless legs syndrome

Rotigotine is a non-ergolinic dopamine receptor agonist, formulated as a silicone-based transdermal patch, which has been evaluated for use in the treatment of adults with moderate to severe restless legs syndrome (RLS). Transdermal rotigotine improved the symptoms of RLS in two well designed 6-month trials in adults with idiopathic, moderate to severe RLS. Rotigotine (1-3 mg/24 h in one study and 2 or 3 mg/24 h in the other) decreased the International RLS Study Group Severity Rating Scale (IRLS) sum score and the Clinical Global Impression (CGI) item-1 assessment (severity of symptoms) from baseline (co-primary endpoints) to a significantly greater extent than placebo. Over half of rotigotine recipients were classified as treatment responders according to the IRLS sum score and CGI item-1 and item-2 ratings. Improvements in RLS symptoms have been maintained in the long term with rotigotine, according to the 3-year results of an open-label extension trial. Transdermal rotigotine was generally well tolerated in clinical trials and long-term extension studies in patients with moderate to severe RLS. There was a low risk of augmentation (i.e. intensification of RLS symptoms) with rotigotine, although further evaluations are required to ascertain if continuous dopaminergic stimulation has the effect of limiting or preventing augmentation.