Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic, currently in Phase III clinical development for procedural sedation in the U.S. The US commercialization rights to Remimazolam were licensed to Cosmo Pharmaceuticals, NV from PAION UK based in Cambridge, UK, an affiliate of PAION AG , Germany. 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. Remimazolam is expected to have 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 completion of current development of remimazolam for adult patients in procedural sedation. A full clinical development program for general anesthesia has been completed in Japan, and a Phase II study in general anesthesia in cardiac surgery patients has been completed in the E.U. Based on the positive results of the Phase II study in Japan, development for ICU sedation beyond 24 hours is considered following successful completion of development in procedural sedation and general anesthesia.