Boehringer said that the FDA approval was supported by clinical pharmacokinetic data, and by a single randomised, double-blind, placebo-controlled multicenter clinical trial. A second study evaluated an overnight switch from Mirapex to Mirapex ER.
Reportedly, the clinical trial program involved more than 400 patients with early parkinson’s disease who were treated with varying doses of Mirapex ER, Mirapex or placebo and assessed after periods of nine weeks and 18 weeks.
The first study, conducted in people with early parkinson’s disease, compared Mirapex ER and Mirapex, each versus placebo. Patients treated with Mirapex ER experienced clinically symptom relief, as measured by mean change from baseline in Unified Parkinson’s Disease Rating Scale (UPDRS) II+III score, compared with placebo.
Wherein, a second study evaluated the efficacy of an overnight switch from Mirapex to Mirapex ER. 85% (87 of 104) of patients who completed the trial were successfully switched to Mirapex ER. Some patients required dose adjustments.
The 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.
Albert Ros, executive vice president of Boehringer Ingelheim, said: “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. The parkinson’s community now has an important new treatment option with benefits similar to the currently available immediate-release formulation.”