The FTD has been granted for the combination of Sedaconda (isoflurane) administered via Sedaconda ACD (device) for the sedation of ventilated patients in the ICU
The designation follows the data from two P-III studies (INSPiRE-ICU 1 & 2), evaluating the efficacy and safety of inhaled isoflurane, delivered via the Sedaconda ACD vs. propofol (IV) across the US (25-30 sites) in 470 patients & expects to be completed the NDA submission in 2024
The 1EP is the proportion of time spent within the target range of sedation depth in absence of rescue sedation, as assessed acc. to the RASS & 2EPs incl. the use of opioids, the wake-up time, the cognitive recovery after end of sedation, and the spontaneous breathing effort
Ref: PRNewswire | Image: Sedana Medical
Related News:- Acacia Pharma’s Byfavo (remimazolam) Receives the US FDA’s Approval for the Induction and Maintenance of Procedural Sedation
