Published: 22. December, 2023

The study a double-blinded, randomised, placebo-controlled in adults demonstrated that CT001 was superior to…

  • The study a double-blinded, randomised, placebo-controlled in adults demonstrated that CT001 was superior to the placebo and ketamine control arms and at par to the sufentanil control arm.
  • CT001 was safe and well tolerated and with response analysis confirming prior observations in children and with a 50% opioid sparring effect of ketamine.
  • The 0205 data demonstrated significant reduction in pain scale, and although superiority was not achieved for the sufentanil control arm in adults the co-primary endpoint of preliminary modelled exposure-response data substantiates that CT001 is superior in children.
  • Exposure-response analysis supports prior observation in children in study 0201 and 0206 and supports advancement of CT001 in the planned 0202 study.

22 December – Cessatech A/S (“Cessatech” or “the Company”) today announced topline results from the double-blind, randomised, placebo-controlled 0205 study that investigated efficacy, safety, and tolerability of CT001 as postoperative analgesic treatment in adults, following impacted mandibular third molar extraction. CT001 has a significant potential to reduce pain in children as demonstrated with data from the study 0205 translated into children using the planned PKPD modelling and simulation. Although CT001 was not superior to sufentanil due to the low exposure of CT001 in adults, the co-primary endpoint of preliminary modelled exposure-response data substantiates that CT001 is superior in children. 

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