DGAP-Adhoc PAION REPORTS POSITIVE REMIMAZOLAM TOPLINE DATA IN EU PHASE III TRIAL IN GENERAL ANESTHESIA
DGAP-Ad-hoc: PAION AG / Key word(s): Research Update
PAION REPORTS POSITIVE REMIMAZOLAM TOPLINE DATA IN EU PHASE III TRIAL IN GENERAL ANESTHESIA
- Primary endpoint met: remimazolam demonstrated non-inferiority to propofol for anesthetic effect
- Key secondary endpoint met: remimazolam demonstrated superior hemodynamic stability compared to propofol
- EU Phase III program completed; data to serve as basis for MAA submission in general anesthesia
Aachen (Germany), 19 November 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces positive topline data from the pivotal remimazolam EU Phase III trial in general anesthesia. In the trial with 424 patients, remimazolam met both the primary and key secondary endpoints.
The randomized, single-blind, propofol-controlled, confirmatory Phase III trial enrolled 424 ASA III/IV patients (American Society of Anesthesiologists classification III to IV) undergoing planned surgery at more than 20 European sites.
The primary objective of the trial was to demonstrate non-inferiority of remimazolam compared to propofol for the induction and maintenance of general anesthesia during elective surgery. The primary efficacy endpoint was defined as the anesthetic effect of remimazolam and propofol assessed as a percentage of time of a Narcotrend (NCT) index below 60 (depth of anesthesia) during the maintenance phase of general anesthesia. In the final analysis, non-inferiority was demonstrated with an NCT index below 60 with 95.7% (n=235) of the time with remimazolam and 99.1% (n=92) with propofol at a significance level of p=0.0001.