FDA Approves Once-Daily Pramipexole for Early Parkinson's Disease
http://www.docguide.com/news/content...2576D20069EB70
NEW YORK -- February 22, 2010 -- The US Food and Drug Administration (FDA) has approved pramipexole dihydrochloride extended-release tablets (Mirapex ER), a new once-daily treatment option for early idiopathic Parkinson's disease.
The approval was based on data from a single randomised, double-blind, placebo-controlled multicentre study. A second study evaluated an overnight switch from pramipexole dihydrochloride to the extended release formulation.