Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the results of the company's pivotal study Sedaconda (SED001) have been published in the highly ranked scientific journal, the Lancet Respiratory Medicine.
"We are very pleased that the study is published in Lancet Respiratory Medicine. The results of the study, which is the largest in inhaled sedation, point to the efficacy and safety of isoflurane via AnaConDa as well as the benefits of the therapy, namely reduced need of opioids, increased spontaneous breathing and faster awakening. Overall, there are now strong reasons to consider inhaled sedation as a first-line therapy,” said the study's principal investigator in Germany, Associate Professor Andreas Meiser, Saarland University Medical Center, Homburg, Germany.
“The publication is a great recognition for the investigators and for Sedana Medical´s clinical trial. The publication in Lancet Respiratory Medicine, which is the leading journal in the field of intensive care and respiratory medicine, is also important in establishing inhaled sedation as a global standard therapy,” said Peter Sackey, Chief Medical Officer of Sedana Medical.
Short on the Sedaconda study
The results from the Sedaconda study demonstrate that Sedaconda (isoflurane) administered via AnaConDa, compared with intravenous propofol, reduces the need of opioids, facilitates spontaneous breathing, which improves lung function during and after ventilator treatment, and enables a faster and more predictable awakening.
The study was conducted at 23 intensive care clinics in Germany and Slovenia and included 301 mechanically ventilated patients in need of sedation. Half of the patients were treated with Sedaconda administered via AnaConDa and half with propofol. The safety profile of Sedaconda was consistent with previously known findings for isoflurane. The study results form the basis for Sedana Medical's European market approval.
