Proveca and Cessatech have announced the submission of a pediatric-use marketing authorization (PUMA) application for CT001 sufentanil / ketamine nasal spray for the treatment of pain in pediatric patients and said that the EMA has validated the MAA. Proveca acquired the rights to CT001 outside of North America in August 2024. In February 2025, Cessatech announced plans for the submission after receiving a positive notified body opinion regarding CT001, and recently the company announced that a Phase 2/3 pediatric study of the nasal spray had met its primary endpoint.
Proveca CEO Simon Bryson commented, “We are very pleased to have submitted this PUMA application to the EMA for this innovative, new medicine to manage acute pain in children aged 1-17. Proveca and Cessatech signed the exclusive licensing agreement less than 12 months ago, and in this time the team have successfully completed the CMC and clinical programs and prepared the marketing authorization dossier for EU registration. This is a significant milestone, and we look forward to bringing this new treatment to pediatric patients.”
Cessatech CEO Jes Trygved commented, “The EMA application of the CT001 MAA is a proud moment for the team and all of our partners. It reflects years of rigorous clinical development and close collaboration with investigators, regulators and advisors. We believe CT001 can make a meaningful difference for patients facing acute pain, an area where the unmet need remains high. It is amazing that we can submit the application just a few months after the top-line results of the last study, with thanks also to Proveca for their immense effort.”
Read the Proveca and Cessatech press release
