Published: 24. July, 2026

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted…

  • The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the Paediatric Use Marketing Authorisation (PUMA) application for CT001/KemSu (intranasal sufentanil/ketamine). 
  • Proveca intends to request a re-examination of the CHMP opinion in accordance with EMA procedures. 
  • Proveca and Cessatech remain committed to working closely with the EMA throughout the re-examination process. 
  • CT001/KemSu continues to represent an important potential treatment option for children with moderate to severe acute pain 

Jes Trygved, CEO of Cessatech, said: 
“While we are naturally disappointed by today’s opinion, we remain confident in the overall benefit-risk profile of KemSu and in the comprehensive data supporting the application. Together with our partner Proveca, we intend to request a re-examination of the CHMP opinion and will continue to work constructively with the EMA, with the objective of making KemSu available to children who need new treatment options for the management of acute pain. The re-examination process is expected to take several months.” 

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