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

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 ) Related articles Releases 27. August, 2026 CT001 ready for shipment to initial U.S. hospitals as launch activities commence Initial U.S. commercial supply of CT001 now available for shipment Launch activities initiated with... Read more Releases 24. July, 2026 Proveca intends to request a re-examination of CHMP opinion for CT001/KemSu See also the updated Q&A documentation related to the Release: Link The European Medicines... Read more Releases 12. June, 2026 Cessatech enters collaboration with University Hospital of Copenhagen, Rigshospitalet Cessatech enters collaboration with University Hospital of Copenhagen, Rigshospitalet, to advance an intravenous formulation of melatonin for post-anaesthesia delirium (CT004) in children ... Read more Stay up to date! Subscribe and get notified on Cessatech's latest news. An acceptance email will be sent to you, please check your spam. Please leave this field empty Almost there! Please check your inbox to confirm your subscription to Cessatech.

The release as fetched from its publisher. cessatech.com ↗