Our vision is to be the accepted PAIONeer in sedation and anesthesia; helping advance patient care.
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic that has shown positive results in clinical Phase III trials. 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. During clinical studies, remimazolam demonstrated efficacy and safety with around 2,400 volunteers and patients. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.
PAION has completed clinical development of remimazolam for procedural sedation in the U.S. The U.S. licensee Cosmo submitted a New Drug Application (NDA) in procedural sedation in the U.S. in April 2019 and is responsible for any further development activities in the U.S. In Japan, licensee Mundipharma filed for market approval in general anesthesia in December 2018. In China, licensee Yichang Humanwell filed for market approval in procedural sedation in November 2018. In Europe, PAION submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in procedural sedation in November 2019, and a Phase III trial in general anesthesia is ongoing.
In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation beyond 24 hours is another possible attractive indication for further development in the EU by PAION as well as by its licensees in other territories.
Remimazolam is partnered in the U.S. (Cosmo Pharmaceuticals), Japan (Mundipharma), China (Yichang Humanwell), Canada (Pharmascience), Russia/CIS, Turkey and the MENA region (R-Pharm) as well as South Korea (Hana Pharm). For all other markets outside the EU, remimazolam is available for licensing.
More information at Sedation & anesthesia market.