PAION Announces Initiation of U.S. Clinical Safety Trial of Remimazolam in High Risk Patients Undergoing Colonoscopy

MAHWAH, NJ--(Marketwired - December 01, 2015) - PAION, Inc., a wholly owned subsidiary of PAION AG, today announced the initiation of a smaller dedicated safety study of Remimazolam in ASA III/IV patients (American Society of Anesthesiologists classification III to IV) undergoing colonoscopy as part of the U.S. Phase III program. This trial will run alongside the two ongoing pivotal U.S. Phase III trials in colonoscopy and bronchoscopy.

The trial is part of the development program, which PAION and the U.S. Food and Drug Administration (FDA) agreed upon for the filing of Remimazolam in the targeted indication 'procedural sedation'.

Dr. Wolfgang Söhngen, Chief Executive Officer of PAION AG, commented: "ASA III/IV patients are outlined by their significant co-morbidities and therefore have a generally poor health status. Hence, they carry a higher risk for complications during or following medical interventions than otherwise healthy patients.

"Despite the use of midazolam, interventions in these patients are predominantly undertaken in hospitals and with the presence of anesthesiologists to account for the significant co-morbidities in this patient population. Although more than 90 % of colonoscopies are carried out in healthier patients (ASA I/II), it is very important for an overall safety characterization of Remimazolam to generate safety data especially in this more severely diseased patient population."

This prospective, double-blind, randomized, placebo- and active controlled, multicenter, parallel group study involves about 75 high-risk patients (i.e. ASA III/IV) undergoing a colonoscopy with Remimazolam compared to midazolam and placebo. Completion of patient recruitment is expected in 2016.

About Remimazolam

Remimazolam is an ultra-short-acting intravenous sedative and anesthetic currently in Phase III clinical development for procedural sedation and general anesthesia. Remimazolam is a member of the class of substances known as benzodiazepines. In the human body, Remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases, and not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, Remimazolam can be reversed with flumazenil in order to rapidly terminate sedation if necessary.