Paion AG initiates phase III trial for remimazolam for induction and maintenance of general anesthesia.

Paion AG announced the initiation of an EU Phase III clinical trial with remimazolam, for the induction and maintenance of general anesthesia. The randomized, single-blind, propofol-controlled, confirmatory Phase III trial is expected to enroll approximately 500 ASA III/IV patients undergoing non-emergency surgery at more than 20 European trial centres. Patient recruitment is expected to be completed in 2019. The primary objective is to demonstrate the non-inferiority of remimazolam compared to propofol for the induction and maintenance of general anesthesia during elective surgery.

The key secondary objective is to show improved hemodynamic stability (avoidance of intraoperative drop of blood pressure and vasopressor usage) compared to propofol. The trial was designed in consultation with EU key opinion leaders in general anesthesia.