Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily Mirapex ER® (pramipexole dihydrochloride) extended-release tablets for the signs and symptoms of idiopathic Parkinson's disease (PD), which includes early and advanced PD. PD is the second most common chronic neurological disorder in older adults after Alzheimer's. Parkinson's disease has no cure.
"In a pivotal trial of patients with advanced Parkinson's disease, MIRAPEX ER not only demonstrated significant symptom improvement, but also increased the number of hours during which people with advanced Parkinson's disease had better mobility," said Anthony Schapira, M.D., head of department and chairman of Clinical Neurosciences Specialties, The Institute of Neurology, University College London, London, UK. "With this approval, MIRAPEX ER may now help early as well as advanced PD patients with its convenient once-daily dosing schedule."
Study findings showed that patients with advanced PD who were treated with MIRAPEX ER experienced superior symptom relief versus placebo. In addition, MIRAPEX ER demonstrated benefits similar to Mirapex® (pramipexole dihydrochloride) tablets, each versus placebo. Treatment with MIRAPEX ER also resulted in significant reductions of off-time (period of time when symptoms return) versus placebo.
"With the approval of MIRAPEX ER, we are hopeful that this once-daily treatment option may help ease some of the burden and obstacles that people with advanced Parkinson's disease face on a daily basis," said Albert Ros, executive vice president, Boehringer Ingelheim Pharmaceuticals, Inc.
The FDA approval of MIRAPEX ER for advanced PD patients was supported by efficacy data from one randomized, double-blind, placebo-controlled, 3-parallel group clinical study. The clinical trial program involved 517 patients with advanced Parkinson's disease who were treated with varying doses of MIRAPEX ER, MIRAPEX or placebo. The primary efficacy outcome was the adjusted mean change from baseline to week 18 in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III score with Part II averaged for on- and off-time and Part III assessed during on-time. The key secondary efficacy outcome was change in daily off-time at week 18. Maintenance of efficacy was analyzed at 33 weeks.
In the trial, superiority of MIRAPEX ER over placebo was demonstrated after 18 weeks of treatment, on both primary and key secondary efficacy endpoints. In addition, maintenance of efficacy was shown in patients who completed 33 weeks of treatment. In the study, MIRAPEX ER demonstrated similar benefits as MIRAPEX, each versus placebo, in people with advanced PD.
The most common adverse events (incidence greater than or equal to 5 percent and greater than placebo) in advanced PD concomitantly treated with levodopa were dyskinesia, nausea, constipation, hallucinations, headache, and anorexia.
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.