PAION initiates Remimazolam Phase 3 trial in patients undergoing colonoscopy

Mar 31 2015

PAION, Inc., a wholly owned subsidiary of PAION AG, today announced the initiation of a U.S. Phase 3 clinical trial of Remimazolam, an ultra-short-acting sedative/anesthetic, for procedural sedation in patients undergoing colonoscopy.

During Phase 2 clinical trials, Remimazolam displayed faster onset of sedation and greater procedural success compared to midazolam. 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.

Wolfgang Sohngen, M.D., Ph.D., chief executive officer of PAION AG, said: "The initiation of the Phase 3 trial in patients undergoing colonoscopy is an important milestone for PAION. We expect the current study to further confirm Phase 2 data that showed Remimazolam was safe and highly effective in providing procedural sedation. Midazolam has been selected as a comparator because PAION aims to get a label similar to Midazolam."

Greg Papaz, president and chief executive officer of PAION, Inc., added: "The change in the reimbursement of colonoscopies in the US underscores the medical need for an alternative sedation agent. We expect Remimazolam to compete with the safest prescribed sedatives and enable high-patient throughput with a fast onset/rapid recovery, a profile currently unmet in the anesthetic space."

This Phase 3 clinical trial is a prospective, double-blind, randomized, placebo and midazolam-controlled, U.S. multicenter study in 460 patients undergoing colonoscopies for diagnostic or therapeutic reasons. Patients will be randomized 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.