Policy & Regulation
Sedana Medical applies to FDA for US clinical trials
24 November 2021 -

Swedish medtech and pharmaceutical company Sedana Medical AB (Nasdaq First North Growth Market:SEDANA) revealed on Wednesday that it has applied to conduct phase III pivotal clinical trials with its Sedaconda products in the United States.

The company has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) and is aiming for a combination registration of the medical device Sedaconda ACD and the pharmaceutical Sedaconda (isoflurane) for inhaled sedation of mechanically ventilated patients in intensive care.

Subject to approval of the IND, Sedana Medical plans to commence patient recruitment at the turn of Q1/Q2 2022 for two multi-centre, randomised controlled, assessor-blinded clinical trials, with the objective to obtain US approval in 2024.

The primary endpoint in each study will be to show that Sedaconda, administered via Sedaconda ACD, is effective and non-inferior to propofol for sedation of mechanically ventilated patients in the intensive care unit. The secondary endpoints relate to opioid requirements, spontaneous breathing, wake-up time and cognitive recovery.