Sedana Medical AB (publ) has announces that the company has submitted an application for market approval for Sedaconda (isoflurane) for inhaled sedation in intensive care in Italy.
“With the application in Italy, we are hoping to bring our Sedaconda products to yet another important European market. Having received market approval in 14 European countries to date, we are aiming to receive further approvals in Poland, Italy, Switzerland, and the UK during 2022. This would allow us to offer the first and only on-label therapy for inhaled sedation of mechanically ventilated intensive care patients in all major European markets." said Johannes Doll, CEO of Sedana Medical.
Sedaconda (isoflurane), which is administered via the medical device Sedaconda ACD, has shown important benefits over intravenous sedation in Sedana Medical's pivotal phase III study SED001, including reducing the need of opioids, facilitating spontaneous breathing, and enabling a faster and more predictable awakening. To date, Sedaconda (isoflurane) has been approved in Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Ireland, the Netherlands, Norway, Portugal, Slovenia, Spain, and Sweden.
Source: Sedana Medical