Cessatech A/S announced the final simulated efficacy data in children with CT001 from the abstract that will be presented at the Population Approach Group Europe (PAGE) conference in Rome Italy, during 26-28 June 2024. The simulated pain reduction in Numeric Rating Scale (NRS) in children using CT001 was -87% (76%/92%) with a 95% CI for n=37. When using sufentanil alone the change in NRS was -52% (34%/65%) and with ketamine it was -32% (12%/47%), with a +10% (1%/20%) increase for placebo.

The pain relief estimated for CT001 would be difficult to obtain with?sufentanil in children and would likely require more than double the?sufentanil?exposure, while increasing?sufentanil or?ketamine?exposure could lead to side-effects like respiratory depression or hallucinogenic effects. Only 9% of children are expected to require a second dose of CT001. The simulated data strongly supports the efficacy of CT001 in children and is the substantial part of modelling and simulation Study 0207 and 0208.

The data will be important in the regulatory process and later commercialization of CT001. CT001 is a nasal spray in development for the treatment of acute and procedural pain in children. The development of CT001 in Europe is conducted on the basis of an approved paediatric investigation plan (PIP) from EMA's Paediatric Committee.