FDAnews

ROTIGOTINE DEMONSTRATES EFFICACY AND SAFETY IN PATIENTS WITH EARLY STAGE PARKINSON'S DISEASE

Daily use of the rotigotine transdermal patch appears to provide continued safety and efficacy in patients with early Parkinson's disease, according to interim data from the open-label extension phase of a Phase III multicenter, randomised, double-blind, placebo-controlled study.

Patients were entered into the trial's open label phase if they had completed the double-blind treatment protocol. In total, 177 patients were randomised to rotigotine and 96 patients to placebo for six months. The study drug was initiated at a dose of 2 mg every 24 hour (10 cm2) for three weeks to a maximum dose of 6 mg/ 24 hour (30 cm2). After one year of open-label treatment patients could receive up to 16 mg/24 hour (80 cm2).