The US Food and Drug Administration (FDA) approved Neupro (rotigotine transdermal system) for the treatment of the signs and symptoms of advanced stage idiopathic Parkinson’s disease (PD) and as a treatment for moderate-to-severe primary restless legs syndrome (RLS).
Neupro, a dopamine agonist patch that provides continuous drug delivery for patients with PD and RLS, was previously approved by the FDA for the signs and symptoms of early stage idiopathic PD. The FDA has also approved the new formulation of Neupro.
"RLS can be a serious condition with symptoms that can affect patients at any point in the day or night; and Parkinson’s disease symptoms can have a broad impact on patients. Neupro 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," said William Ondo, MD, professor, Department of Neurology, University of Texas at Houston Medical School.
The efficacy of Neupro in the treatment of RLS was primarily evaluated in two fixed-dose, randomized, double-blind, placebo-controlled trials with 6-month maintenance periods. Patients received Neupro doses ranging from 0.5 mg/24 hours to 3 mg/24 hours, or placebo, once daily.
Statistically significant improvements in sum scores on the International RLS Rating Scale (IRLS Scale) and the Clinical Global Impression – Improvement (CGI-I) assessment were observed in RLS patients receiving Neupro compared with those receiving placebo. The IRLS Scale contains 10 items designed to assess the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence, and impact on activities of daily living and mood associated with RLS. The CGI-I is designed to clinically assess progress in RLS symptoms on a 7-point scale.
The most common adverse reactions (≥5% greater than placebo) for the highest recommended dose of Neupro for treatment of RLS were application site reactions, nausea, somnolence, and headache.
