FDA Approves Pramipexole Extended Release for Advanced Parkinson's
By Susan Jeffrey
Medscape Medical News
March 25, 2010 — The US Food and Drug Administration (FDA) has approved the use of once-daily pramipexole (Mirapex, Boehringer Ingelheim Pharmaceuticals) for use in advanced Parkinson's disease (PD), the company has announced.
The new approval comes after a similar FDA approval in February 2010 for the use of pramipexole extended-release tablets in early PD.
Use of the extended-release formulation in advanced patients was supported by data from 1 randomized, double-blind controlled trial, according to a statement from Boehringer-Ingelheim. A total of 517 patients were randomly assigned to varying doses of once-daily extended-release pramipexole, immediate-release pramipexole taken 3 times daily, or placebo.
The primary endpoint was adjusted mean change at week 18 in the United Parkinson's Disease Rating Scale parts 2 and 3; the score for part 2 was averaged for on and off time, and part 3 was assessed during on time, the Boehringer-Ingelheim statement notes.
Both extended- and immediate-release pramipexole were superior to placebo after 18 weeks of treatment on both the primary and secondary endpoints, including change in daily off time at week 18. Maintenance of efficacy was also seen at week 33 vs placebo. Results were similar with both the extended- and immediate-release formulations of pramipexole vs placebo, the statement said.
The most common adverse events, those with an incidence of more than 5%, and greater than placebo in those with advanced PD who were treated concomitantly with levodopa, were dyskinesia, nausea, constipation, hallucinations, headache, and anorexia.
With this approval, the extended-release formulation "may now help early as well as advanced PD patients with its convenient once-daily dosing schedule," said Anthony Schapira, MD, head of department and chairman of Clinical Neurosciences Specialties at the Institute of Neurology, University College London, United Kingdom, in the Boehringer-Ingelheim release.
