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

nson's disease (PD) and for moderate-to-severe primary restless legs syndrome (RLS). Pramipexole is supported by more than a decade of real-world experience in the treatment of Parkinson's disease, with more than 10 million prescriptions written in the U.S. since its launch in 1997.

Patients have reported falling asleep without perceived warning signs during activities of daily living, including operation of a motor vehicle, which sometimes resulted in accidents. Hallucinations and postural (orthostatic) hypotension may occur. In clinical trials for early PD using immediate release tablets, the most commonly reported side effects of pramipexole that were more frequent than with placebo are nausea (28% vs. 18%), dizziness (25% vs. 24%), somnolence (22% vs. 9%), insomnia (17% vs. 12%), asthenia (14% vs. 12%), and constipation (14% vs. 6%). In clinical trials for advanced PD, the most commonly reported side effects of pramipexole that were more frequent than with placebo are postural hypotension (53% vs. 48%), dyskinesia (47% vs. 31%), extrapyramidal syndrome (28% vs. 26%), insomnia (27% vs. 22%), dizziness (26% vs. 25%), accidental injury (17% vs. 15%), hallucinations (17% vs. 4%), and dream abnormalities (11% vs. 10%).

Patients and caregivers should be informed that impulse control disorders and compulsive behaviors have been reported in patients taking dopamine agonists, including pramipexole.

A once-daily, extended release formulation of pramipexole dihydrochloride tablets is currently under review by the U.S. Food and Drug Administration for the treatment of the signs and symptoms of idiopathic Parkinson's disease (PD).

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.'/>"/>

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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