Cessatech A/S announced that EMA's Paediatric Committee (PDCO) has agreed to reduce the number of required children in the final clinical study with CT001 from 300 to 150 children. Study 0202 is the final required clinical study that will evaluate the safety profile for CT001 in children. The company presented new data from both adult and paediatric studies to PDCO and with this additional information, the PDCO agreed to the proposed changes to the clinical development program for CT001.

The significant reduction of children means that study 0202 can be completed faster and at a significant lower cost than previously assumed. The study is now approved by the competent authorities in Spain and UK where the study will recruit. The company expects the study to start during First Quarter 2024.

CT001 is a nasal spray under development for treatment of acute and procedural pain in children. The development of CT001 in Europe is done in line with an approved paediatric investigation plan (PIP) by EMA's Paediatric committee.