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Paion Launches US Phase 3 Clinical Trial of Colonoscopy Sedative
31 March 2015 - - German specialty pharmaceutical company Paion AG's US-based Paion, Inc. subsidiary has launched a US Phase 3 clinical trial of its Remimazolam ultra-short-acting sedative/anesthetic for procedural sedation in patients undergoing colonoscopy, the company said on Tuesday. During Phase 2 clinical trials, Remimazolam displayed faster onset of sedation and greater procedural success compared to midazolam, Paion said. Remimazolam showed a benign safety profile and patients experienced rapid recovery from sedation including faster recovery of cognitive function as compared to midazolam. The initiation of the Phase 3 trial in patients undergoing colonoscopies marks the start of Paion's Phase 3 clinical program, which includes a second pivotal Phase 3 trial in patients undergoing bronchoscopies and a third smaller safety trial in high-risk patients undergoing colonoscopies. In parallel, Paion will conduct three Phase 1 studies. This Phase 3 clinical trial is a prospective, double-blind, randomized, placebo and midazolam-controlled, US multicenter study in 460 patients undergoing colonoscopies for diagnostic or therapeutic reasons. Patients will be randomised to receive Remimazolam, midazolam or placebo in addition to fentanyl to achieve moderate sedation. The primary objective of this study is to investigate the short-term sedation, and hence the success of a colonoscopy compared to placebo and midazolam. The primary endpoint is the successful completion of the colonoscopy procedure with no requirement for alternative sedative. The completion of patient recruitment is expected before the end of 2015. Remimazolam's rapid offset is a consequence of its metabolism by tissue esterase enzymes that are widely distributed throughout the body.
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