Pramipexole extended release in Parkinson’s disease

Abstract

Pramipexole extended release (ER) is a new once-daily formulation of pramipexole, a nonergot dopamine agonist, which is available in five dosage strengths: 0.26 (0.375) mg, 0.52 (0.75) mg, 1.05 (1.5) mg, 2.1 (3) mg and 3.15 (4.5) mg (all doses are expressed in terms of pramipexole base and the corresponding dose strengths of pramipexole salt are given in brackets). Pramipexole ER is currently approved as monotherapy in early Parkinson’s disease (PD), as well as an adjunct therapy to levodopa in advanced PD. Compared with the immediate release (IR) formulation, the ER formulation offers several advantages, including the potential for improved compliance owing to its simple once-daily dosing regimen and steadier plasma levels over 24 h. Double-blind, randomized, placebo and active comparator controlled trials in early, as well as advanced PD, established the superiority of both pramipexole ER and IR over placebo. The overnight switch from pramipexole IR three times a day to ER once-daily in early PD has been shown to be successful in more than 80% of patients. Pramipexole ER is well tolerated, with a similar adverse event profile to pramipexole IR. The aim of this article is to provide a short review of the most relevant pharmacological and clinical data on pramipexole ER.

Keywords::

• dopamine agonist
• once-daily formulation
• Parkinson’s disease
• PD treatment
• pramipexole
• pramipexole ER
• pramipexole extended release
• pramipexole/pharmacodynamics
• pramipexole/pharmacokinetics

Financial & competing interests disclosure

Klaus Seppi has received honoraria for speaking and/or consulting from Novartis, AstraZeneca, Boehringer Ingelheim, Lundbeck, Schwarz Pharma, UCB Pharma, Teva and GlaxoSmithKline, and grants/research funding from The Movement Disorders Society, Michael J Fox Foundation for Parkinson’s Research, ‘Österreichische Nationalbank’, Austrian Science Fund (FWF) and Medical University Innsbruck. Werner Poewe has received consultancy and lecture fees from AstraZeneca, Teva, Novartis, GlaxoSmithKline, Boehringer-Ingelheim, UCB, Orion Pharma and Merck Serono in relation to clinical drug development programs for PD, and grants/research funding from The Movement Disorders Society, Michael J Fox Foundation for Parkinson’s Research, ‘Österreichische Nationalbank’, Austrian Science Fund (FWF) and Medical University Innsbruck. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.