Remimazolam: Phase IIb data

The double-blind, U.S. Phase IIb Study CNS7056-004 trial in 160 patients undergoing a colonoscopy showed that all 3 doses of Remimazolam were superior to midazolam on the primary endpoint of procedural success rates as measured by a composite of sedation sufficient to initiate and complete the procedure, no mechanical or manual ventilation and no rescue sedation (97.5%, 95% and 92.5%, respectively, vs. 75%; p=0.007, p=0.025 and p=0.066). Paion said the trial was not designed to detect statistical significance. Additionally, patients treated with low-, mid- and high-dose Remimazolam achieved faster mean times to full alertness vs. Remimazolam (13.3, 11.3 and 13.6 minutes, respectively, vs. 15.2 minutes). Patients received initial doses of 5, 7 or 8 mg IV Remimazolam with supplemental doses of 3, 2, and 3 mg, respectively, as required to maintain adequate sedation, or midazolam. ...