New data presented today at the Movement Disorder Society’s 13th International Congress of Parkinson’s Disease and Movement Disorders (MDS) further confirms high therapeutic benefit of Mirapexin/Sifrol (pramipexole) once-daily, extended release formulation (also referred to as prolonged release formulation).
The trial, performed in patients with advanced Parkinson’s disease (PD), showed results comparable to pramipexole’s already long-established immediate release formulation.
This study supports data from a previous trial that demonstrated the efficacy, safety and tolerability of the once daily formulation in the treatment of early PD at 18 weeks, and non-inferiority between pramipexole extended release and pramipexole immediate release at 33 weeks as presented for the first time today at the MDS.
The randomised, placebo-controlled trial assessed the efficacy and safety of a once-daily, extended release formulation of pramipexole – administered as adjunctive therapy in advanced PD – compared to its immediate formulation when administered under the same therapeutic conditions. Both the primary and the key secondary endpoints were met in the study as measured by the change from baseline in UPDRS II+III and percentage of off-time during waking hours.
“These most recent study data show that the pramipexole once-daily, extended release formulation is effective not only in early but also in the more advanced stages of Parkinson’s disease. The improvement seen in “off-time” (known as a period of dramatically reduced motor functioning at the end of the dosing interval), as well as the convenience of a once-daily formulation, is a benefit both patients and physicians will welcome. Having a once-daily pill is especially important for those in an advanced stage of the disease when the need for multiple medications often increases,” commented Professor Anthony Schapira, lead investigator of the study, Chairman of the University Department of Clinical Neurosciences, Institute of Neurology, Queen Square, UCL and Professor of Neurology at the National Hospital and Royal Free Hospital, London, UK.