Avera Pharmaceuticals has announced the successful completion of a Phase II clinical study of gantacurium chloride as an adjunct to general anesthesia to enable rapid intubation of patients undergoing surgery. Gantacurium chloride is a new, investigational, non-depolarizing ultra-short-acting neuromuscular blocker.
The multicenter, randomized, controlled, observer-blinded dose-response study was designed to evaluate the efficacy and safety of gantacurium chloride for injection in healthy adult patients undergoing endotracheal intubation prior to surgery under general anesthesia. The study enrolled 230 subjects with American Society of Anesthesiologists (ASA) physical status classification 1 and 2 (healthy or mild systemic disease), who were given gantacurium, succinylcholine or placebo. The study met its primary outcome endpoint, achieving greater than 90 percent acceptable intubations at 60 seconds after injection. Gantacurium was generally well tolerated and no serious adverse events were observed.