PAION Initiates Phase III for an Ultra-Short-Acting Sedative
Paion announced a U.S. Phase III clinical trial of Remimazolam, an ultra-short-acting sedative for procedural sedation in patients undergoing colonoscopy. Remimazolam’s U.S. Phase III Program to include two pivotal trials and one smaller safety trial launching in 2015.
Remimazolam is an innovative ultra-short-acting general anesthetic. Its rapid offset is a consequence of its metabolism by tissue esterase enzymes that are widely distributed throughout the body. As a result of this short duration of action and good controllability, it has a preferable efficacy and safety profile relative to other currently marketed anesthesia compounds. Remimazolam has a potential use in the following three indications:
- Procedural sedation (Lead indication U.S.)
- General anesthesia (Lead indication EU, Japan)
- ICU sedation
During Phase II 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 III trial in patients undergoing colonoscopies marks the start of PAION’s Phase III clinical program, which includes a second pivotal Phase III trial in patients undergoing bronchoscopies and a third smaller safety trial in high-risk patients undergoing colonoscopies.
Wolfgang Sohngen, chief executive officer of PAION AG, said: “The initiation of the Phase III trial in patients undergoing colonoscopy is an important milestone for PAION. We expect the current study to further confirm Phase II 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.”
Remimazolam is already available for licensing outside China, Russia (CIS) Turkey, MENA Region, South Korea and Canada, where the compound is partnered with Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm and Pendopharm.
Greg Papaz, president and CEO 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.“
In parallel with Remimazolam’s pipeline, PAION will conduct another three Phase I studies.