Paion's remimazolam meets in Phase III trial for procedural sedation

Paion AG (Xetra:PA8) reported data from a Phase III trial in 431 patients undergoing bronchoscopy showing that procedural sedation with remimazolam (CNS 7056, ONO-2745) met the composite primary endpoint vs. both placebo and midazolam of a greater proportion of patients who completed bronchoscopy without rescue medication, and no more than 5 doses within a 15-minute window for remimazolam or placebo and no more than 3 doses within any 12-minute window for midazolam (82.5% vs. 5% and 33.8%, respectively, p<0.0001).

On secondary endpoints, remimazolam led to a shorter median time from the start of medication to start of procedure (5 minutes vs. 17 and 15.5 minutes, respectively, p<0.0001), a shorter median time from the end of procedure to return to full alertness (6 minutes vs. 13.5 and 12 minutes, respectively, p=0.0001), and improved the recognition discrimination index raw score of the Hopkins Verbal Learning Test 5 minutes after full alertness (4.6 points vs. 2.6 and 2.9 points, respectively, p=0.0003) vs. both placebo and midazolam. Other secondary endpoints in the double-blind, U.S. trial include time to discharge and recall of procedure...