Sedana Medical clinical studies

The Sedaconda study

In 2020, Sedana Medical completed the Sedaconda study (SED001), the largest randomised, controlled, open-label trial performed to date on inhaled sedation in intensive care.

The phase 3 study aimed to confirm the efficacy and safety of sedation with Sedaconda (isoflurane) administered via the Sedaconda ACD in mechanically ventilated ICU patients, comparing it to standard sedation with intravenously administered propofol. A total of 301 patients from 24 intensive care clinics in Germany and Slovenia were randomized to either sedation method.

The study successfully reached its primary endpoint, demonstrating Sedaconda’s non-inferiority to intravenous propofol in maintaining an adequate depth of sedation. Additionally, the results showed that sedation with Sedaconda reduced the need for opioids, facilitated spontaneous breathing, and enabled a faster and more predictable awakening. In terms of safety, Sedaconda was well tolerated, with a safety profile consistent with previous findings for isoflurane. Taken together, the SED001 study results confirm the clinical experience of inhaled sedation as an effective and safe method of sedation.

The results were published in the Lancet Respiratory Medicine journal (Meiser et al., 2021) and constituted the basis for Sedana Medical's European marketing approval for Sedaconda for inhaled sedation. 

 

The IsoCOMFORT study

In 2021, Sedana Medical initiated the IsoCOMFORT study (SED002), a paediatric study aiming to investigate whether sedation with Sedaconda (isoflurane) administered via the Sedaconda ACD is safe and more effective than intravenously administered midazolam in mechanically ventilated ICU paediatric patients between 3-17 years old.

Currently, midazolam is the only sedation option for children in ICU because propofol is contraindicated due to the risk of serious adverse events. The patients will be sedated for 12–48 hours with either sedation method and the primary endpoint will be the proportion of time spent at adequate sedation depth.
The study will involve 160
 patients from intensive care clinics in Spain, Germany, Sweden and France, and completion is estimated for the second half of 2022. The results of the study are expected to lead to an approved paediatric indication for inhaled sedation. 

Sedana Medical Clinical Studies

SED003 and SED004 

In 2022, Sedana Medical will commence the SED003 and SED004 studies. These are two identical phase 3 studies aiming to confirm the efficacy and safety of sedation with isoflurane administered via the Sedaconda ACD. These studies are of strategic importance as they will form the basis for a new drug application (NDA) filing at the FDA in the US.  

The SED003 and SED004 studies will be blinded to meet the requirements of the FDA and the primary endpoint will be the proportion of time spent at adequate sedation depth. They will be carried out at approximately 30 sites in the US and enrol a total of 500 patients. It is estimated that the first patient will be included during Q1/Q2 2022.