R-Pharm Group and the Specialty Pharma Company PAION AG (Germany) announced that the Phase III trial in general anesthesia conducted in Russia has been successfully completed.
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic that has already shown positive results in clinical Phase III trials.
The Phase III trial was a multicentre, single-blind randomized clinical trial comparing the efficacy and safety of remimazolam and propofol in surgery patients undergoing general anesthesia. The trial was conducted in six medical facilities in Russia and included 150 patients, randomized in two groups, one half was administered with remimazolam, while the other half received propofol. The trial data further confirmed the high safety and efficacy profile of remimazolam.
Following this successful completion of the Phase III clinical trial, in Q1 2019 R-Pharm plans to start filing in order to receive marketing authorization from the Ministry of Healthcare of the Russian Federation.
Mikhail Samsonov, Chief Medical Officer of R-Pharm, commented:
“We are inspired by the results of this Phase III clinical trial. The research, conducted in Russia, came to the same conclusions as several other international trials. PAION’s remimazolam is an anesthetic agent that fully meets all safety and efficacy requirements and standards existing for this type of treatment.”
Paion AG is a specialty pharmaceutical company, develops and commercializes drugs for use in out-patient and hospital-based sedation, anesthesia, and critical care services worldwide. The company was founded in 2000 and is headquartered in Aachen (Germany) with an additional site in Cambridge (UK). Its lead product is Remimazolam, an intravenous ultra-short-acting anesthetic.
R-Pharm was founded in 2001 and is based in Moscow (Russia). The company engages in the manufacture of finished dosage forms, active pharmaceutical ingredients of chemical nature, and biotech substances; research and development of innovative products and technologies; and implementation of education and training programs for pharmaceutical and healthcare industries.