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Sedana Medical AB (SEDANA) announced that the FDA has granted Fast Track Designation for the evaluation of isoflurane via the Sedaconda ACD-S device. This designation aims to expedite the development of therapies addressing serious conditions, enhancing communication with the FDA and potentially allowing Rolling Review of the New Drug Application. Sedana Medical is conducting two Phase III studies, INSPiRE-ICU 1 and 2, to confirm the efficacy and safety of inhaled sedation with isoflurane for mechanically ventilated ICU patients, with an NDA submission expected in 2024 and launch anticipated in early 2025.
