FDA Approves Rotigotine Transdermal System

Emma Hitt, PhD

April 03, 2012

April 3, 2012 — A once-daily continuous delivery dopamine agonist patch, a rotigotine transdermal system (Neupro, UCB), has been approved by the US Food and Drug Administration for the treatment of Parkinson's disease (PD) and restless legs syndrome (RLS).

Specifically, the rotigotine transdermal system is now indicated for the treatment of the signs and symptoms of advanced-stage idiopathic PD and for treatment of moderate-to-severe primary RLS. The rotigotine patch was previously indicated only for the signs and symptoms of early-stage idiopathic PD.

This agent "provides a novel way of treating RLS and PD through continuous transdermal dopaminergic delivery. It can help patients manage the unpredictable nature of these chronic conditions," noted William Ondo, MD, professor, Department of Neurology, University of Texas Health Science Center at Houston, in a written release.

The patch has been evaluated in several trials of PD and RLS. Its efficacy in idiopathic PD was established in 5 randomized, placebo-controlled trials in which patients received a weekly titration (in increments of 2 mg per 24 hours) to receive the randomized dose or the optimal dose.

In 3 trials, the rotigotine transdermal system significantly improved Unified Parkinson's Disease Rating Scale scores in patients with early-stage PD over scores for patients receiving placebo. In 2 additional trials in patients with advanced PD, statistically significant changes in off-times were observed in patients with advanced PD receiving the patch compared with those who received placebo.

For the treatment of RLS, the rotigotine patch was evaluated in 2 randomized trials with 6-month maintenance periods, in which patients received a dosage of 0.5 mg to 3 mg per day, or placebo.

Treatment with the rotigotine patch was associated with a statistically significant improvement in sum scores on the International RLS Rating Scale and the Clinical Global Impression–Improvement assessment.

The most common adverse reactions, with an incidence of at least 5% more than with placebo, included nausea and somnolence.

Hallucinations in patients with advanced PD can be increased; some patients may experience new or worsening mental status and behavior changes that can be severe, including psychotic-like behavior during treatment, or while starting or increasing the dose of the agent. As with other dopamine agonists, cases of patients having intense urges to gamble, increased sexual urges, spending sprees, or binge eating have been reported, and patients should be monitored for these kinds of changes while being treated.

This transdermal product can also cause application site reactions, some of which may be severe, although most were mild or moderate and limited to the patch area.