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First new drug in nearly a decade
ROCKVILLE, Md.-The FDA has approved the first new Parkinsons drug in eight years.
In two key clinical trials, pramipexole (Mirapex, Pharmacia & Upjohn), a dopamine agonist, improved motor function and performance of daily activities in 388 patients with early disease. Coupled with levodopa for 260 patients with advanced disease, the combo reduced off hours from six to four a day. On average, pramipexole patients levodopa use was reduced 27%.
Side effects, ranging from nausea and dizziness to postural hypotension and hallucinations, were similar to those of other drugs in this class. -Judith Groch
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