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Avera Pharmaceuticals
Completes Successful Phase 2 Study of Gantacurium Chloride for Endotracheal
Intubation
SAN
DIEGO - June 27, 2006
Avera Pharmaceuticals, Inc., a privately held pharmaceutical company developing medicines that act on the nervous system, today announced the successful completion of a Phase 2 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.
"We are very encouraged by the overall safety and efficacy results in this study,"said Jeffrey F. McKelvy, president and chief executive officer of Avera Pharmaceuticals, Inc. "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 (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% acceptable intubations at 60 seconds after injection. Gantacurium was generally well tolerated and no serious adverse events were observed.
Avera
Pharmaceuticals, Inc.
Avera Pharmaceuticals, Inc. (San Diego, CA) is a private, emerging pharmaceutical
company focused on the development and commercialization of novel compounds
in the neuroscience therapeutics arena. The Company's mission is to identify
opportunities for therapeutic advances in the treatment of neurologic and
psychiatric disorders, and to in-license and develop compounds that can meet
these needs. Additional information on the Company can be found at www.averapharm.com.
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