According to Cessatech, the Phase 2/3 Pediatric Study 0202 of the company’s CT001 sufentanil / ketamine nasal spray in children with severe pain met its primary endpoint, with more than half of patients reporting pain relief at 15 minutes post dose and almost 90% reporting pain relief at 30 minutes. Cessatech announced the initiation of the study in May 2024. The company said that it would work with Proveca, which acquired rights to CT001 outside of North America in August 2024, on a submission to the EMA, with that process expected to begin by the end of 2025.
The pediatric study enrolled 152 pediatric patients seen in the emergency department with moderate to severe pain resulting from injury. Cessatech reports that results were consistent across age groups, and the intranasal analgesic was well tolerated, with no unexpected adverse events reported.
Cessatech Chief Scientific Officer Martin Juhl commented, “It is truly encouraging to see CT001 perform so effectively in the demanding environment of emergency departments across Europe. The efficacy demonstrated in Study 0202 is compelling: not only did we observe a median overall pain reduction of 75% at 30 minutes, but the responder rates were also very strong. For instance, 95% of children in Study 0202 experienced at least a 30% reduction in pain, after 30 minutes, which is highly consistent with the 93% predicted by our unified adult-pediatric model. Furthermore, 86% in Study 0202 achieved at least a 50% pain reduction, closely mirroring the 84% predicted by the same modeling. Critically, these positive efficacy results are coupled with a benign safety profile, with all AEs being transient and of mild to moderate intensity. This combination of robust, clinically meaningful pain relief and favorable safety is a remarkable outcome and strongly supports CT001’s potential for pediatric acute pain.”
CEO Jes Trygved said, “We are extremely pleased with this milestone in our final study for the development of CT001 in pediatric patients, especially as it requires significant effort to recruit so many children and to secure the trust and consent of their parents. The results clearly demonstrate that CT001 can make a meaningful difference for children who need rapid, needle-free pain relief during acute medical procedures. With this positive outcome, we are one step closer to bringing an innovative, child-friendly analgesic to children, caregivers and healthcare professionals worldwide.”
Read the Cessatech press release
