Sedana Medical AB (publ) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the evaluation of isoflurane via the Sedaconda ACD-S device for sedation of mechanically ventilated patients in the intensive care (ICU) setting. Fast Track is a process designed to facilitate the development, and expedite the review of therapies that treat serious conditions and fill an unmet medical need. The purpose is to get important new therapies to the patient earlier.

Clinical programs with Fast Track Designation may benefit from frequent communication with the FDA throughout the development and review process and may be eligible to Accelerated Approval and Priority Review if relevant criteria are met. Another possible benefit may be a Rolling Review, which means that completed sections of the New Drug Application (NDA) can be submitted for review by FDA, rather than waiting until every section of the NDA is completed. Sedana Medical is aiming for a combination registration of the medical device Sedaconda ACD and the pharmaceutical isoflurane for sedation of mechanically ventilated intensive care patients in the United States.

Two identical Phase III studies, INSPiRE-ICU 1 and 2, are ongoing with the objective to confirm the efficacy and safety of inhaled sedation with isoflurane delivered via Sedaconda ACD in intensive care. Sedana Medical will engage in discussions with the FDA on how the development program can benefit from the FTD. At present, the guidance regarding the timeline is unchanged: assuming rapid enrolment of patients and successful trials, Sedana Medical expects the NDA submission in 2024 and a launch in early 2025.

The INSPiRE-ICU (Inhaled Sedation vs Propofol in Respiratory failure) studies are two identical phase III studies aiming to confirm the efficacy and safety of inhaled isoflurane, delivered via the Sedaconda ACD, for the sedation of adult mechanically ventilated ICU patients, in comparison to intravenous infusion of propofol. The studies will enrol a total of 470 adult patients across 25-30 sites in the US. Patient enrolment is expected to be completed in 2023.

The primary endpoint is the proportion of time spent within the target range of sedation depth in absence of rescue sedation, as assessed according to the Richmond Agitation Sedation Scale (RASS). In addition, the studies will investigate several secondary endpoints, including the use of opioids, the wake-up time, the cognitive recovery after end of sedation, and the spontaneous breathing effort. The assessments will be performed by blinded assessors to meet the requirements of the FDA.