Source: DGNews  |  Posted 1 year ago

NEW YORK -- February 22, 2010 -- The US Food and Drug Administration (FDA) has
approved pramipexole dihydrochloride extended-release tablets (Mirapex ER), a
new once-daily treatment option for early idiopathic Parkinson’s disease.

The approval was based on data from a single randomised, double-blind,
placebo-controlled multicentre study. A second study evaluated an overnight
switch from pramipexole dihydrochloride to the extended release formulation.

The study involved more than 400 patients with early Parkinson’s disease who
were treated with varying doses of pramipexole dihydrochloride ER, pramipexole
dihydrochloride or placebo and assessed after periods of 9 and 18 weeks.

The first study, conducted in people with early Parkinson’s disease, compared
pramipexole dihydrochloride ER and pramipexole dihydrochloride, each versus
placebo. Patients treated with pramipexole dihydrochloride ER experienced
clinically significant symptom relief, as measured by mean change from baseline
in Unified Parkinson’s Disease Rating Scale 2+3 score, compared with placebo.

A second study evaluated the efficacy of an overnight switch from pramipexole
dihydrochloride to pramipexole dihydrochloride ER. In that study, 85% (87 of
104) of patients who completed the trial were successfully switched to
pramipexole dihydrochloride ER. Some patients required dose adjustments.

The most commonly reported side effects were nausea, dizziness, sleepiness,
difficulty falling asleep, weakness, and constipation.

SOURCE: Boehringer Ingelheim