Sedana Medical phase III study of IsoConDa meets primary endpoint
Sedana Medical AB (publ), a medical device company, announced a positive top line result for the company’s pivotal phase III study, IsoConDa. The study reached its primary endpoint; to show that IsoConDa (isoflurane), administered with AnaConDa, is an effective sedation method, for ventilator-intensive care patients, which is non-inferior to propofol.
Secondary endpoints are under analysis and will be published together with the primary endpoint in a scientific journal after peer-review. The results indicate that IsoConDa is an effective and safe sedation method and will form the basis for the company’s application for European market approval later this autumn.
“We are proud to have conducted the world’s largest study of inhaled sedation in intensive care. This is the most significant milestone in inhaled sedation since the development of the AnaConDa. The study confirms the clinical experience of IsoConDa administered with AnaConDa as an effective and safe sedation method. With the results from the study, we are in a good position for the future, both with the continued global clinical development of inhaled sedation and the work with the application for market approval in Europe,” said Peter Sackey, chief medical officer of Sedana Medical.
“The study results are in line with the long-standing clinical experience of many doctors all over the world. Isoflurane is safe and efficacious as a sedative for invasively ventilated critically ill patients. We hope that more patients will benefit from the advantages of inhaled sedation in the future” said Coordinating Investigator Germany of the IsoConDa study Assoc. Prof. Andreas Meiser, Saarland University Medical Center, Homburg, Germany.
The study, which aims to support the approval of the candidate drug IsoConDa (isoflurane) for inhaled sedation in intensive care in Europe, has been conducted at 21 centers in Germany and three in Slovenia. The study is a noninferiority study, which means that its primary purpose is to show that IsoConDa, administered with AnaConDa, is non-inferior to propofol in maintaining an adequate sedation level. This is determined by comparing the proportion of time that adequate sedation depth is maintained with isoflurane compared to propofol.
The study included 301 mechanically ventilated intensive care patients in need of sedation and is a so-called randomized, controlled and open-label study to confirm efficacy and safety. The patients were divided into two equal groups, where patients in one group were treated intravenously with propofol and the other with IsoConDa administered with AnaConDa.
“The goal we had when we initiated the work with the IsoConDa study several years ago was to be able to register inhaled sedation with IsoConDa administered with AnaConDa and thus approach our vision to make inhaled sedation a new standard method in intensive care units around the world. With these strong results as a base, we have come a giant leap closer to our vision. We will submit our application for European market approval in 16 European countries in a first registration round as soon as possible in the fourth quarter 2020. If all goes well, we expect an approval during the second half of 2021,” said Christer Ahlberg, CEO of Sedana Medical
