Boehringer Ingelheim has received approval from the European Commission for Mirapexin/Sifrol, a prolonged-release, once-daily tablet for the treatment of Parkinson’s disease.
Approval was granted on the basis of clinical trial results, which showed that the new once–daily formulation can offer the same efficacy and safety profile comparable to the immediate-release tablet taken three times daily.
The trial also showed that patients on the immediate-release tablets can be switched to the prolonged-release tablet, at the same daily dose, overnight.
Boehringer Ingelheim senior vice-president of medicine Manfred Haehl said that European approval of the new formulation marks another big step in meeting patients’ needs.
“We are very pleased that due to the robust evidence base, the regulatory review experienced no delay, which will allow the first European countries to make the once-daily tablet available to patients,” Haehl said.
A new drug application for the once-daily, extended release formulation of pramipexole (marketed under the trade name Mirapex in the US) is under review with the US Food and Drug Administration.