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

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  • After 18 weeks, patients treated with MIRAPEX ER experienced statistically significant improvement versus placebo in UPDRS II+III score.
  • In a nine-week study, the majority of early PD patients treated with MIRAPEX were successfully switched overnight to MIRAPEX ER.
    • Patients treated with MIRAPEX were randomized overnight to MIRAPEX ER or to MIRAPEX. Primary efficacy endpoint was the proportion of patients successfully switched (no worsening of UPDRS II+III >15 percent from baseline and no drug-related adverse event leading to withdrawal) to MIRAPEX ER. More than 95 percent of patients completed the trial. Eighty-five percent (87 of 104 patients) were successfully switched (some patients required dose adjustments) to the once-daily formulation. These data support a 1:1 switch from MIRAPEX to MIRAPEX ER for most patients.
  • In both of the studies, the safety and tolerability profile of MIRAPEX ER in patients with early PD was similar to that of MIRAPEX when each was compared with placebo.

  • *The Unified Parkinson's Disease Rating Scale (UPDRS)


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    SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
    Copyright©2010 PR Newswire.
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