Pramipexole extended release (ER) is a non-ergolinic
dopamine receptor agonist available for use as a once-daily oral treatment for the signs and symptoms of early and advanced
idiopathic Parkinson's disease. Once-daily
pramipexole ER and three times-daily
pramipexole immediate release (IR) have similar exposure over 24 hours. The ER formulation is associated with fewer fluctuations in plasma
pramipexole concentrations over this period.
Pramipexole ER improved the symptoms of
Parkinson's disease in three well designed trials in adults with early or advanced disease, as measured by changes from baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III subtotal scores. In a 9-week study, the majority of patients with early
Parkinson's disease who were receiving stable
pramipexole IR treatment were successfully switched to
pramipexole ER. Relative to placebo at week 18,
pramipexole ER 0.375-4.5 mg (of the
salt) once daily significantly decreased the sum of the UPDRS parts II and III subtotal scores from baseline in two trials in patients with early or advanced
Parkinson's disease, and also reduced the percentage of off-time during waking hours in patients with advanced disease. The efficacy of
pramipexole ER was maintained after 33 weeks of treatment in the trials in patients with early or advanced
Parkinson's disease.
Pramipexole ER was generally well tolerated in patients with
Parkinson's disease, with the rate of adverse events being generally similar to that with
pramipexole IR.