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.
The key secondary objective was to show improved hemodynamic stability compared to propofol. Hemodynamic stability is measured by avoidance of intraoperative drop in mean arterial blood pressure (MAP) between start of anesthesia and 15 minutes after the first skin incision, as well as usage of vasopressors. Although adjustments in the statistical testing were required based on the nature of the obtained data, a statistically significant superior hemodynamic stability of remimazolam compared to propofol could be shown with a number of hemodynamic events per patient of 62.62 ± 39.46 (n=270) with remimazolam and 71.03 ± 41.12 (n=95) with propofol at a significance level of p=0.0151.
End of inside information
Information and Explanation of the Issuer to this News:
In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019.
PAION's mission is to be a leading specialty pharmaceutical company in the fields of anesthesia and critical care by bringing novel products to market to benefit patients, doctors & other stakeholders in healthcare.
PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).
19-Nov-2020 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
|Listed:||Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange|
|EQS News ID:||1149475|
|End of Announcement||DGAP News Service|
1149475 19-Nov-2020 CET/CEST