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FDA Approves Once-Daily Pramipexole for Early Parkinson’s Disease NEW YORK -- February 22, 2010 -- The US Food and Drug Administration (FDA) has approved pramipexole dihydrochloride extended-release tablets (Mirapex ER), a new once-daily treatment option for early idiopathic Parkinson’s disease. The approval was based on data from a single randomised, double-blind, placebo-controlled multicentre study. A second study evaluated an overnight switch from pramipexole dihydrochloride to the extended release formulation. The study involved more than 400 patients with early Parkinson’s disease who were treated with varying doses of pramipexole dihydrochloride ER, pramipexole dihydrochloride or placebo and assessed after periods of 9 and 18 weeks. The first study, conducted in people with early Parkinson’s disease, compared pramipexole dihydrochloride ER and pramipexole dihydrochloride, each versus placebo. Patients treated with pramipexole dihydrochloride ER experienced clinically significant symptom relief, as measured by mean change from baseline in Unified Parkinson’s Disease Rating Scale 2+3 score, compared with placebo. A second study evaluated the efficacy of an overnight switch from pramipexole dihydrochloride to pramipexole dihydrochloride ER. In that study, 85% (87 of 104) of patients who completed the trial were successfully switched to pramipexole dihydrochloride ER. Some patients required dose adjustments. The most commonly reported side effects were nausea, dizziness, sleepiness, difficulty falling asleep, weakness, and constipation. SOURCE: Boehringer Ingelheim E-mail this page to a friend or colleague! To print, use this version