Cessatech announces that the Paediatric Committee has agreed to a 50% reduction of the required number of patients in the final study of its nasal spray for the treatment of acute pain in children

Published: 25. October, 2023

The European Paediatric Committee (PDCO) has agreed to a 50% reduction in the number…

• The European Paediatric Committee (PDCO) has agreed to a 50% reduction in the number of children required in the final safety study (0202) of CT001 for the treatment of acute and procedural pain in children
• New safety data from both adult and paediatric studies has been presented to PDCO and based on this information, the PDCO agreed to the proposed reduction in number of children
• With this PDCO opinion, study 0202 will have a much shorter recruitment period and at less costs that previously anticipated. The study is now approved by the competent authorities in Spain and UK

Jes Trygved, CEO, Cessatech
We are very pleased with the acknowledgement from PDCO and that we can now initiate the study with a much lower number of children. A great effort by the team and the sites involved. With the agreement from EMA’s Paediatric Committee, CT001 is now one step closer to finalize the clinical program and becoming available to hospitals and the children that really need approved, easy to administer pain relief.”

Link to press release (Update on Study 0202)