Sedana Medical

The purpose of the pre-NDA meeting is to seek FDA´s confirmation on different strategic topics in preparation for the NDA submission. The main objective was to confirm that available safety and efficacy data are sufficient for submission and review. FDA agreed that the safety and efficacy data from our clinical studies SED003 and SED004, supported by the European study SED001 and published literature, appear adequate to permit submission and review of the NDA for the proposed indication of sedation of adult patients requiring mechanical ventilation. The Agency was also in agreement with most of the company’s proposals regarding structure and contents of the file.

FDA requested an additional description and analysis of the run-in training patients from both US studies. As run-in patients served for the initial training of clinical trial sites and were thus not randomized, these analyses were not part of the initial proposed plan and will therefore require some additional work for side-by-side comparisons of the study populations in the clinical part of the submission. The NDA submission is now expected to be around mid-year 2026.

“We are very pleased with the very productive and collaborative pre-NDA meeting with the FDA. Based on the Agency’s feedback, we are confident about our upcoming NDA submission. The additional work is manageable, and our team is fully focused on completing it as quickly as possible. With two successful US clinical trials, Fast Track designation, the Early Access Program, and now a positive pre-NDA meeting, we are well on our way towards bringing inhaled sedation to our highest-potential market”, said Johannes Doll, CEO of Sedana Medical.