Denmark-based Cessatech said its commercialization partner Proveca will request a re-examination after the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on a Pediatric Use Marketing Authorisation (PUMA) application for CT001 (KemSu), an intranasal combination of sufentanil and ketamine for moderate to severe acute pain in children aged 1-17 years.
The CHMP opinion is not the EMA's final decision. Under the agency's review process, applicants may request a re-examination before the European Commission makes a legally binding determination.
KemSu combines the opioid agonist sufentanil with the NMDA receptor antagonist ketamine in a needle-free nasal spray intended to provide rapid analgesia without intravenous access. The product was developed by Cessatech for pediatric use and is being commercialized in Europe by UK-based Proveca under the PUMA pathway, which is designed to encourage pediatric development of established medicines.
Cessatech said it and Proveca remain confident in KemSu's benefit-risk profile and the data supporting the application. The companies plan to engage with the EMA during the re-examination process, which is expected to take several months, although the CHMP's specific concerns were not disclosed.