According to Cessatech, the EMA’s Committee for Medicinal Products for Human Use has
adopted a negative opinion regarding Proveca’s pediatric-use marketing authorization (PUMA) of KemSu (CT001) sufentanil / ketamine nasal spray for the treatment of pain in children aged 1 to 17. The company said that Proveca, which acquired ex-US rights to the nasal spray in August 2024 and submitted the PUMA in August 2025, intends to request re-examination of the opinion.
Cessatech CEO Jes Trygved commented, “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.”
Read the Cessatech press release
