SEDANA MEDICAL

Sedana Medical's NDA for Inhaled Isoflurane Sedation Accepted by FDA for Review

- The U.S. FDA has accepted Sedana Medical's New Drug Application for isoflurane delivered via the Sedana Medical ACD Delivery System for sedation of mechanically ventilated adult ICU patients. - The submission is supported by two pivotal trials, INSPIRE ICU-1 and INSPIRE ICU-2, both of which met their primary endpoint and showed statistically significant reduction in opioid use. - If approved, the therapy would be the first and only inhaled sedation treatment approved in the United States for mechanically ventilated ICU patients. - The FDA will assign a target action date under the Prescription Drug User Fee Act (PDUFA) in the coming weeks.