Cessatech

On 28 June – Cessatech A/S (“Cessatech” or “the Company”) announces that the presentation is now available from the Population Approach Group Europe (PAGE) conference in Rome, Italy. The new significant findings revealed that relative drug exposure is much higher in young children, with bioavailability decreasing with age.

Recent anatomical data indicated that infants have nearly double the relative nasal surface area compared to adults. This insight, derived from both historical data and recent MRI studies of children aged 0-18 years, underscores the importance of age-specific considerations in nasal drug delivery.

The insights gained from these studies are pivotal in refining the dosing strategy for CT001. The proposed posology is effective and safe, reducing the need for higher opioid doses, which is critical in paediatric pain management. The addition of ketamine increases efficacy and spares opioids, ensuring adequate pain relief with minimal side effects.

https://www.page-meeting.org/default.asp?abstract=11064

CT001 is a nasal spray in development for the treatment of acute pain in children. The development of CT001 in Europe is conducted on the basis of an approved paediatric investigation plan (PIP) from EMA’s Paediatric Committee. 

Martin Juhl, CSO, Cessatech
“The collaboration with Occams paediatric PKPD expert Rik Schoemaker has been immensely fruitful. The combined expertise has allowed us to quantify and confirm the synergistic benefits of combining sufentanil and ketamine in CT001, demonstrating its opioid-sparing effect and supporting the proposed posology for providing adequate pain relief in children. These findings are crucial for the registration of CT001 as a safe and efficacious non-invasive treatment that can significantly enhance paediatric pain management.”

Jes Trygved, CEO, Cessatech
“We are very pleased with the final results and the opportunity to present them at the PAGE conference. The data strongly support our hypothesis that CT001 is highly effective in children relative to its active comparators and will be instrumental in our further development. This is a significant step towards finalizing the clinical program and making CT001 available to hospitals and the children who need approved, easy-to-administer pain relief.”