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Sedative candidate for colonoscopy procedures advances to phase 3 trial
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An ultra-short-acting sedative to be used during colonoscopy procedures was advanced to a phase 3 clinical trial, according to a press release from the manufacturer.
Compared with midazolam, the candidate remimazolam (PAION Inc.) initiated sedation quicker and patients recovered and regained cognitive function earlier during phase 2 clinical trials, according to the release.
“The initiation of the phase 3 trial in patients undergoing colonoscopy is an important milestone for PAION,” Wolfgang Sohngen, MD, PhD, CEO of PAION AG, said in the press release. “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.”
The prospective, double-blind phase 3 trial will randomize 460 patients undergoing colonoscopies throughout multiple centers in the U.S. to remimazolam, midazolam or placebo supplementary to fentanyl. The primary endpoint of the trial is to complete a colonoscopy without requiring additional alternative sedatives, according to the release.
“The change in the reimbursement of colonoscopies in the U.S. underscores the medical need for an alternative sedation agent,” Greg Papaz, president and chief executive officer of PAION Inc., said in the release. “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.”
Patient recruitment for the remimazolam phase 3 trial is slated to end before 2015, according to the release. Remimazolam is also being studied as a general anesthetic in the European Union and Japan, and an ICU sedative in Japan.
The announcement of remimazolam entering a phase 3 trial launches PAION’s phase 3 clinical program which will also conduct two other phase 3 trials – one that will study patients undergoing bronchoscopies and another that will assess the safety of high-risk patients undergoing colonoscopies.