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Once-Daily MIRAPEX ER Now Approved by FDA for Both Early and Advanced Parkinson's Disease
Date:3/23/2010

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"With the approval of MIRAPEX ER, we are hopeful that this once-daily treatment option may help ease some of the burden and obstacles that people with advanced Parkinson's disease face on a daily basis," said Albert Ros, executive vice president, Boehringer Ingelheim Pharmaceuticals, Inc.

Clinical Trials

The FDA approval of MIRAPEX ER for advanced PD patients was supported by efficacy data from one randomized, double-blind, placebo-controlled, 3-parallel group clinical study. The clinical trial program involved 517 patients with advanced Parkinson's disease who were treated with varying doses of MIRAPEX ER, MIRAPEX or placebo. The primary efficacy outcome was the adjusted mean change from baseline to week 18 in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III score with Part II averaged for on- and off-time and Part III assessed during on-time. The key secondary efficacy outcome was change in daily off-time at week 18. Maintenance of efficacy was analyzed at 33 weeks.

In the trial, superiority of MIRAPEX ER over placebo was demonstrated after 18 weeks of treatment, on both prima
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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