Phase III clinical study of Remimazolam starts in Russia

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R-Pharm began the Phase III clinical study of the medicine used to induce and maintain the general anesthesia. Remimazolam was prescribed to the first patient in August 2017.

This international, multi-center, simple blind randomized Phase III clinical study is conducted to compare the efficacy and safety of Remimazolam and Propofol in patients during a routine surgery under the general anesthesia. The clinical trials will be conducted in the Russian Federation and involve 150 patients.

“This is great news for PAION. We are very pleased that R-Pharm, our partner, is actively involved in the research and development of Remimazolam. We are looking forward to further news from Russia,” said Dr. Wolfgang Söhngen, Chief Executive Officer at PAION AG.

“We place great hopes on Phase III of clinical trials of Remimazolam, which has already demonstrated high safety profile and efficacy in other countries. I am confident that our collaboration with PAION, a real pioneer in the area of anesthesia and sedation, will be long and fruitful,” said Vasily Ignatiev, General Director of R-Pharm Group.

The rights to develop and commercialize Remimazolam in the Russian market were transferred to R-Pharm in 2013. Later, the parties signed a number of supplements to the license agreement stipulating that R-Pharm would also register and commercialize Remimazolam in the Middle East and North Africa.

SOURCE: gmpnews.ru
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