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Neupro Launched in U.S. to Treat Parkinson’s Disease and Restless Legs Syndrome
The effectiveness of rotigotine in the treatment of the signs and symptoms of idiopathic PD was established in five parallel-group, randomized, double-blind, placebo-controlled trials conducted in the U.S. and abroad. Depending on the trial design, PD patients underwent a weekly titration of rotigotine in 2 mg/24 hrs increments to either the randomized dose or the optimal dose.
The efficacy of rotigotine 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 rotigotine dosages ranging from 0.5 mg/24 hrs to 3 mg/24 hrs or placebo once daily.
In clinical trials, the most common adverse reactions for the highest recommended doses of Neupro for the treatment of PD were nausea, vomiting, somnolence, application-site reactions, dizziness, anorexia, hyperhidrosis, insomnia, peripheral edema, and dyskinesia. The most common adverse reactions for the highest recommended dose of Neupro for the treatment of RLS were application-site reactions, nausea, somnolence, and headache.
Read the news story from the Sacramento Bee.