Avera Pharmaceuticals Inc. (News) announced Tuesday the completion of a Phase II clinical study of gantacurium chloride as an adjunct to general anesthesia to enable rapid intubation of patients undergoing surgery on Tuesday.
Gantacurium chloride is a new, investigational, non-depolarizing ultra-short acting neuromuscular blocker.
"We are very encouraged by the overall safety and efficacy results in this study," said Jeffrey F. McKelvy, president and chief executive officer. "Furthermore, as the first ultra-short acting, non-depolarizing neuromuscular blocker, we believe gantacurium will fill a significant unmet need in the anesthesia marketplace for both rapid and routine tracheal intubation and skeletal muscle relaxation during surgery. With these excellent results, we are currently in licensing discussions for this asset."
The multi-center, 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 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.
Snapshot: Avera Pharmaceuticals Inc.
10955 Vista Sorrento Parkway, Suite 250
San Diego, CA 92130
Avera Pharmaceuticals Inc. is an emerging pharmaceutical company focused on the acquisition, development and commercialization of novel pharmaceutical compounds in the neuroscience therapeutics arena.
GW280430A, neuromuscular blocking agent, Phase I; gantacurium chloride, neuromuscular blocking agent, Phase II
Jeffrey F. McKelvy: President and CEO
Michael D. Lack: COO
Joao Siffert, M.D.: Vice President, Clinical Research and Development
Susan Knudson: Senior Director, Finance and Administration