The FDA has approved Mirapex ER (pramipexole dihydrochloride extended-release tablets, from Boehringer-Ingelheim Pharmaceuticals) as a treatment for the signs and symptoms of early idiopathic Parkinson’s disease. This approval was based on data from a single, randomized, double-blind, placebo-controlled, multicenter clinical trial, and from a second study evaluating an overnight switch from Mirapex (pramipexole dihydrochloride tablets) to Mirapex ER.
Results from the first study demonstrated that patients treated with Mirapex ER experienced clinically significant symptom relief, as measured by the mean change from baseline in Unified Parkinson’s Disease Rating Scale (UPDRS)* II+III score, compared with placebo. In the second study, data showed that 85% of patients who completed the trial were successfully switched from Mirapex to Mirapex ER.
Mirapex ER is not indicated for the treatment of advanced Parkinson’s disease or restless legs syndrome (RLS).
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