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Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic, currently in Phase III clinical development for procedural sedation. In the human body, remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation and anesthesia if necessary.
In clinical studies, remimazolam demonstrated efficacy and safety in over 1,000 patients. A Phase III program is currently in progress in procedural sedation in the U.S. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.
A pediatric development plan has been agreed with the FDA and will be implemented following the development of remimazolam for adult patients. A full clinical development program for general anesthesia has been completed in Japan, and a Phase II study in general anesthesia has been completed in the E.U. Development for ICU sedation beyond 24 hours is considered following successful completion of development in procedural sedation and general anesthesia.