Paion and the US partners of the Aachen-based company are making decisive progress with the planned, timely marketing start for the newly approved anesthetic remimazolam in the US. The drug has been classified as a Group IV drug by the Drug Enforcement Administration. “This group includes drugs with a low potential for abuse and a low risk of addiction. BYFAVO has thus received the same classification as e.g. B. Midazolam and Diazepam, ”Paion said in a statement on Tuesday afternoon.
With the classification of the substance by the Drug Enforcement Administration, one final regulatory hurdle has been removed. The FDA had already given the go-ahead for Paion’s anesthetic in the summer. This means that nothing stands in the way of the start of marketing, which should begin in 2020.
“We will now start labeling and packaging the commercial product so that we can make BYFAVO available to patients as soon as possible. We expect the product to be available for sale in the US before the end of the year. Our first product, BARHEMSYS (amisulpride injection) for post-operative nausea and vomiting, was launched in August and we are already registering product sales. We are excited to offer these two drugs to physicians and their patients in the United States, ”said Mike Bolinder, CEO of Paion’s US marketing partner Acacia Pharma.