CT002 – A non-invasive nasal spray for conscious sedation of children undergoing medical procedures
CT002 is a nasal spray intended for procedural sedation in children who need to remain calm and still during diagnostic or therapeutic procedures. CT002 aims to offer predictable onset, is easy to administer and has a favourable sedative profile suitable for paediatric use. As a needle-free option, it reduces the discomfort and anxiety associated with intravenous (IV) sedation, which is the standard practice today.
The nasal spray contains dexmedetomidine, a well-known sedative agent approved for adult use and widely used off-label for paediatric sedation. Today, dexmedetomidine is typically administered intravenously and not authorized for children in Europe. Despite this, clinicians increasingly use the IV solution intranasally in children due to its ability to provide sedation that mimics natural sleep, with minimal risk of respiratory depression. However, no approved, standardized paediatric formulation exists.
CT002 is designed to address this gap by providing a ready-to-use, non-invasive formulation tailored for children and suitable for routine hospital procedures. A controlled intranasal dose may help streamline workflow, improve the child’s experience and reduce procedure delays or escalation to general anaesthesia.
CT002 has the potential to become the first intranasal sedation treatment specifically designed for children undergoing medical procedures such as MRI scans, CT scans and other interventions requiring moderate sedation.
CT002 development program
Cessatech has received an EMA-approved Paediatric Investigational Plan (PIP) for CT002, outlining the required clinical and quality studies to advance the product toward regulatory submission.