UCB announced that the FDA has 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). The FDA has also approved UCB’s new formulation of Neupro, following a recall in April 2008 due to the formation of rotigotine crystals in the patches.
The efficacy of Neupro in treatment of the signs and symptoms of idiopathic PD was established in five parallel group, randomized, double-blind placebo-controlled trials conducted in the US and abroad. Depending on trial design, patients underwent a weekly titration of Neupro in 2mg/24 hours increments to either the randomized dose or optimal dose. The efficacy of Neupro in the treatment of RLS was evaluated in two fixed-dose, randomized, double-blind, placebo-controlled trials with six-month maintenance periods. Patients received Neupro doses ranging from 0.5mg/24 hours–3mg/24 hours, or placebo once daily.
Neupro is a dopamine agonist patch that provides continuous drug delivery for patients with PD and RLS. Neupro was previously approved for the signs and symptoms of early stage idiopathic PD. Neupro is expected to be available in July 2012.
For more information call (800) 477-7877 or visit www.neupro.com.