- Key secondary endpoint met: remimazolam demonstrated superior hemodynamic stability compared to propofol
- - 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.
- Assuming approval in procedural sedation, PAION plans to submit an extension of the marketing authorization for remimazolam for general anesthesia.
- In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.
- In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation.