Sedana Medical phase III study of candidate drug IsoConDa (isoflurane) for inhalation sedation in intensive care in Europe, shows smaller variations in efficacy than anticipated and the study will therefore only need to cover a total of 300 patients instead of initially estimated 550 patients.
Sedana’s CEO Christer Ahlberg said that the interim analysis shows a low standard deviation in the primary variable, the proportion of time with adequate sedation, i.e. the effect of IsoConDa and propofol, which is a good news.
He explained that this means that we will need to include fewer patients in the study to show the same effect than we initially anticipated.
“At the current rate of inclusion our estimation is that we can include the last patient in the study around the turn of the year 2019/2020, which means that we expect to submit an application for market approval in the summer of 2020 in 16 European countries in a first round of registration. If all goes well, we can have a European market approval in the second half of 2021,” said CEO of Sedana Medical.