MIRAPEX ER (pramipexole dihydrochloride) extended-release tablets from Boehringer-Ingelheim
The FDA has approved Mirapex ER (pramipexole dihydrochloride extended-release tablets, from Boehringer Ingelheim) for the signs and symptoms of advanced idiopathic Parkinson's disease (PD). This approval was based on data from a randomized, double-blind, placebo-controlled, 3-parallel group clinical study in 517 patients with advanced PD who were treated with varying doses of Mirapex ER, Mirapex or placebo. The primary efficacy outcome was the adjusted mean change from baseline to week 18 in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III score with Part II averaged for on- and off-time and Part III assessed during on-time. The key secondary efficacy outcome was change in daily off-time at week 18.
In the trial, superiority of Mirapex ER over placebo was demonstrated after 18 weeks of treatment, on both primary and key secondary efficacy endpoints. In addition, maintenance of efficacy was shown in patients who completed 33 weeks of treatment. In the study, Mirapex ER demonstrated similar benefits as Mirapex, each versus placebo, in people with advanced PD.
Mirapex ER is already approved for the treatment of the signs and symptoms of early idiopathic Parkinson's disease.