Danish startup Cessatech, a spin out from Rigshospitalet, announced that it has gotten the go-ahead for a pivotal trial of its CT001 analgesic nasal spray. Cessatech is developing CT001, a fixed dose combination of sufentanil and ketamine, for use in pediatric patients and has already completed dosing in a Phase 2 PK study of the nasal spray in children aged 1-17.
The new study, 0205, will evaluate the efficacy of CT001 for pain relief in adults as part of a pediatric investigation plan approved by the EMA, the company said. The randomized double-blind placebo controlled trial is expected to enroll 220 dental patients who have undergone extraction of impacted third molars, and Cessatech expects enrollment to be completed by early next year.
Cessatech CEO Jes Trygved expressed irritation with the regulatory process: “We are very pleased with finally being able to initiate this important trial, and the company is now moving into a different stage with its pivotal study – great work and effort by all the people involved in the preparation of this trial. Unfortunately, it has taken much too long a time and we are disappointed that the approval process, in particular with the Ethical Committee, is so cumbersome and not in favor of an innovative company and industry. CT001 is getting closer to the market and its potential patients and the period ahead will be extremely interesting.”
Read the Cessatech press release.
