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FDA Approves Once-Daily MIRAPEX ER for the Treatment of Early Parkinson's Disease
Date:2/22/2010

ght switch from MIRAPEX to MIRAPEX ER. The clinical trial program involved more than 400 patients with early Parkinson's disease who were treated with varying doses of MIRAPEX ER, MIRAPEX or placebo and assessed after periods of nine weeks and 18 weeks. The first study, conducted in people with early Parkinson's disease, compared MIRAPEX ER and MIRAPEX, each versus placebo. Patients treated with MIRAPEX ER experienced clinically significant symptom relief, as measured by mean change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS)* II+III score, compared with placebo. A second study evaluated the efficacy of an overnight switch from MIRAPEX to MIRAPEX ER. Eighty-five percent (87 of 104) of patients who completed the trial were successfully switched to MIRAPEX ER. Some patients required dose adjustments.

Early Parkinson's disease Clinical Highlights:

  • Patients with early PD who were treated with MIRAPEX ER showed clinically significant improvement in symptoms after 18 weeks compared to placebo. In the same study, MIRAPEX-treated patients experienced similar clinically significant improvements, compared to placebo. <
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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