Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Mirapex ER® (pramipexole dihydrochloride) extended-release tablets, a new once-daily treatment option for the signs and symptoms of early idiopathic Parkinson's disease (PD). MIRAPEX ER is not indicated in advanced PD. Parkinson's disease is a chronic, slowly progressive and potentially debilitating neurological condition affecting nearly one million people in the U.S., with one person newly diagnosed every nine minutes.
"MIRAPEX ER for early Parkinson's disease is a positive development in the treatment of this disease. This new, once-daily treatment has a more convenient dosing schedule, offering greater flexibility as someone with early Parkinson's disease plans his or her day," said Robert Hauser, M.D., professor of Neurology, and director, Parkinson's Disease & Movement Disorders Center at the University of South Florida College of Medicine. "In general, patients often prefer once-daily dosing to a more frequent regimen because of convenience."
Findings from clinical studies show MIRAPEX ER to be superior to placebo and with benefits comparable to the currently available immediate-release MIRAPEX in early Parkinson's disease. More than twelve years of real-world experience supports the use of pramipexole in the treatment of Parkinson's disease.
"We are committed to providing effective treatment options that may help ease the burden of Parkinson's disease, and the MIRAPEX ER approval is very exciting," said Albert Ros, executive vice president, Boehringer Ingelheim Pharmaceuticals, Inc. "The Parkinson's community now has an important new treatment option with benefits similar to the currently available immediate-release formulation."
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.