DGAP-News

PAION REPORTS POSITIVE REMIMAZOLAM TOPLINE DATA IN EU PHASE III TRIAL IN GENERAL ANESTHESIA - Seite 2

Remimazolam is currently under regulatory review in the EU in procedural sedation. Assuming approval in procedural sedation, PAION plans to submit an extension of the marketing authorization for remimazolam for general anesthesia. A decision on market approval in procedural sedation is currently expected in the first half of 2021 with a CHMP opinion (Committee for Medicinal Products for Human Use) expected by the end of January 2021.

"The study results confirmed that remimazolam compared to propofol resulted in less events of critical intraoperative hypotension (IOH), defined as an arterial blood pressure decrease below 65 mm Hg ([1],[2]), and therefore has the potential to be an important addition to existing options for induction and maintenance of general anesthesia in class ASA III/IV patients", commented Prof. Dr. Jörg Fechner, international coordinating and principal investigator, University Hospital Erlangen, and added: "I possibly will have the chance to present some study data during my presentation at the Euroanaesthesia virtual congress on 29th of November 2020."

Dr. Juergen Beck, Chief Development Officer at PAION AG, commented: "We are excited about the topline data and remimazolam's potential to serve as an effective, safe and efficient agent for general anesthesia. The efficacy and safety results we are reporting today confirm data from earlier studies. We look forward to preparing a marketing application also in general anesthesia."

Dr. Jim Phillips, CEO at PAION AG, commented: "I would like to thank the clinical study sites and patients who participated in this important study. As we have seen clearly during the ongoing coronavirus crisis, there is a need for more anesthesia options. We believe that remimazolam has the potential to play a significant role in improving patient care and we will make a supplementary submission to the EMA in 2021 for approval for use in general anesthesia, once we have received feedback (and we hope an approval) for procedural sedation."

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About remimazolam
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic. In the human body, remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and is not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation or anesthesia if necessary. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.