BI's Mirapex ER approved in US for advanced Parkinson's disease
This article was originally published in Scrip
The US FDA has approved Boehringer Ingelheim's Mirapex ER (pramipexole hydrochloride) as a once daily treatment for the signs and symptoms of advanced idiopathic Parkinson's disease (PD). The prolonged-release drug was approved earlier this year for early PD in the US, and is approved in the EU for both early and advanced PD.
An immediate, three-times daily, formulation of the dopamine receptor agonist has been available for PD in the US since 1997.
The approval was backed in part by a 517-subject trial, in which patients with advanced PD were randomised to Mirapex, Mirapex ER or placebo for 33 weeks. Mirapex ER provided superior symptom relief than did placebo as assessed by the unified Parkinson's disease rating scale (UPDRS), says BI, and had similar benefits to Mirapex.
The most common adverse events (incidence greater than or equal to 5%and greater than placebo) in patients with advanced PD concomitantly treated with levodopa were dyskinesia, nausea, constipation, hallucinations, headache and anorexia.
"With this approval, Mirapex ER may now help early as well as advanced PD patients with its convenient once-daily dosing schedule," said Dr Anthony Schapira, of the Institute of Neurology at University College London, in a BI statement.