PAION initiated a dedicated safety study of Remimazolam in American Society of Anesthesiologists classification III to IV patients undergoing colonoscopy as part of the U.S. Phase III program.
Here are four things to know:
1. The trial will run alongside the two ongoing pivotal U.S. Phase III trials in colonoscopy and bronchoscopy.
2. The trial is part of the development program that PAION and the FDA agreed upon for the filing of Remimazolam in the targeted indication 'procedural sedation'.
3. Remimazolam is an ultra-short-acting intravenous sedative and anesthetic.
4. This double-blind, randomized, multicenter, parallel group study includes around 75 high-risk patients undergoing a colonoscopy.