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New Studies on Once-Daily Extended Release Pramipexole Presented at American Academy of Neurology Annual Meeting
Date:4/29/2009

Data indicated comparable efficacy and safety for extended release and immediate release formulations of pramipexole

SEATTLE, April 29 /PRNewswire/ -- New findings from two double-blind studies investigating the efficacy, safety and tolerability of pramipexole dihydrochloride tablets in an extended release, once-daily formulation, for the treatment of Parkinson's disease (PD), are being presented today at the American Academy of Neurology (AAN) 61st Annual Meeting in Seattle.

The first study compared the efficacy, safety and tolerability of pramipexole extended release versus the currently available pramipexole immediate release formulation and placebo, in patients with early PD (those who have early symptoms), treated for up to 33 weeks. A statistical analysis conducted at week 18 demonstrated that the pramipexole extended release formulation was superior to placebo and had comparable efficacy to the pramipexole immediate release formulation. Further analysis among the 84 patients who completed the 33 weeks of treatment indicated maintenance of efficacy.

"It is important to provide patients with a treatment regimen that suits their individual needs," stated Robert Hauser, MD, Professor of Neurology, and Director, Parkinson's Disease & Movement Disorders Center at the University of South Florida College of Medicine, and a co-author on both studies. "These data suggest that this potential formulation may be as effective and as safe as the currently available three-times-a-day formulation."

The second study, also conducted in patients with early PD, assessed the efficacy and safety of an overnight switch from pramipexole immediate release to a pramipexole extended release formulation, at the same daily dose. 84.5 percent of patients who completed the study were switched successfully, meeting the primary endpoint.

About the Studies

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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