Extended-Release Mirapex Approved for Parkinson's Disease
WEDNESDAY Feb. 24, 2010 -- Mirapex ER (pramipexole dihydrochloride extended-release) has been approved by the U.S. Food and Drug Administration as a once-daily option to treat early Parkinson's disease, drug maker Boehringer Ingelheim said in a news release.
Mirapex was first approved more than a decade ago. Approval of the extended-release form was based on a clinical study of more than 400 people with early Parkinson's who were assessed after nine weeks and 18 weeks.
The safety, tolerability and adverse effects of the extended-release form were similar to those of original Mirapex, the company said. The most frequently reported side effects included nausea, dizziness, sleepiness, insomnia, weakness and constipation.
Parkinson's is a chronic, progressive and often debilitating neurological disease affecting close to 1 million people in the United States, the drug maker said. One person is diagnosed with Parkinson's every nine minutes.
The FDA has more information about this drug's approval history.
Posted: February 2010