Paion AG announced that it has submitted an extension application to the Marketing Authorization for remimazolam (Byfavo(R)), PAION's ultra-short-acting intravenous benzodiazepine sedative/anesthetic, for the indication general anesthesia to the European Medicines Agency (EMA). The European Commission approved remimazolam in the EU (including European Economic Area (EEA) countries) for procedural sedation in March 2021. Based on the positive results in the EU Phase III trial in general anesthesia, PAION has now submitted an extension application to the marketing authorization for remimazolam in the indication of general anesthesia.

A decision by the EMA is expected at the end of 2022 or beginning of 2023.