STOCKHOLM, May 29, 2024 /PRNewswire/ -- Sedana Medical AB (publ) announces that all 235 randomized patients have been recruited for its INSPiRE-ICU 2 phase III clinical trial in the United States. Earlier this spring, Sedana Medical reported the completion of enrolment to the parallel phase III clinical trial INSPiRE-ICU 1. The company anticipates topline results from both trials in the second half of 2024, with a planned New Drug Application (NDA) submission in the first quarter of 2025.

"The completion of INSPiRE-ICU 2 concludes Sedana Medical′s clinical trials in the United States. Running this study together with esteemed clinical investigators from highly ranked academic centers such as Columbia, the Harvard-affiliated medical center Beth Israel Deaconess Medical Center and many others has been very exciting and rewarding. Many investigators from the participating sites have been excited to be part of our pioneering studies. The bedside experience in the studies has generated a lot of interest in using inhaled sedation in US practice, which we hope will be possible soon," said Peter Sackey, Chief Medical Officer of Sedana Medical.

Peter Sackey further elaborated: "We now enter into an intense phase of final monitoring, data cleaning and transfer to our statistician team for analysis. In parallel, the long-term outcomes at 3 and 6 months are being collected centrally by the Critical Illness, Brain Dysfunction, and Survivorship team at Vanderbilt Medical Center. With this parallel approach, we expect topline results for the 30-day outcomes in both studies a few months′ apart before the end of this year, and a swift regulatory submission in Q1, 2025."

"The inhaled sedative isoflurane, studied in this trial, is a mainstay of general anesthesia during surgery because of its unique and straightforward pharmacokinetic and pharmacodynamic profile, properties that may potentially also benefit ICU patients. We are very excited to complete enrolment in this trial and eagerly await results evaluating its potential use as a sedative for ventilator-dependent adult ICU patients in the US," said Jeremy Beitler, MD, MPH at Columbia University and Senior Lead Investigator for the INSPiRE-ICU 2 study.

Johannes Doll, President and CEO of Sedana Medical, stated: "Completing enrolment of our clinical program marks an important milestone on our journey towards making inhaled sedation accessible to intensive care patients in the United States. I would like to sincerely thank all our clinical trial sites, partners, and the Sedana Medical team for this significant achievement. It makes me very proud that we have been able to convene this exceptional group of intensive care teams from some of the most prominent US hospitals. Their advice and support will be invaluable as we work towards launching our inhaled therapy on the US market."