Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the 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.