Cardiome Announces Investigational Candidate, Vernakalant, Meets Primary Endpoint in European Comparator Study
VANCOUVER, Dec. 17 /CNW/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that the recently-completed Phase 3 European Comparator Study (the AVRO study) evaluating vernakalant (iv) versus amiodarone for the acute conversion of atrial fibrillation met its primary endpoint.
The AVRO study achieved statistical significance in demonstrating the superiority of vernakalant (iv) over amiodarone in the conversion of atrial fibrillation to sinus rhythm within 90 minutes of the start of drug administration. Overall the data suggests that vernakalant (iv) was well-tolerated in the study population. There were no vernakalant-related deaths or cases of "Torsades de Pointes", a specific and well-characterized ventricular arrhythmia.
Cardiome expects that detailed results of this study will be presented at a scientific conference in 2010.
In April 2009, Cardiome and Merck & Co., Inc. announced a collaboration and license agreement for the development and commercialization of vernakalant, an investigational candidate for the treatment of atrial fibrillation. The agreement provides a Merck affiliate, Merck Sharp & Dohme Corp., with exclusive global rights to vernakalant (oral) for the maintenance of normal heart rhythm in patients with atrial fibrillation, and provides another Merck affiliate, Merck Sharp & Dohme (Switzerland) GmbH, with exclusive rights outside of the United States, Canada and Mexico to vernakalant (iv) for rapid conversion of acute atrial fibrillation to normal heart rhythm. If approved by the European regulatory authorities, Merck has exclusive rights to commercialize vernakalant (iv) in the European Union.
About the AVRO study
The AVRO study, titled "A Phase III Prospective, Randomized, Double-Blind, Active-Controlled, Multi-Center, Superiority Study of Vernakalant Injection Versus Amiodarone in Subjects With Recent Onset Atrial Fibrillation", enrolled a total of 254 patients with symptomatic atrial fibrillation of 3 to 48 hours duration. Subjects were randomized to receive vernakalant (iv) or amiodarone in a 1:1 ratio. Safety was assessed through the monitoring of adverse events, vital signs, continuous telemetry monitoring, 12-lead Holter monitoring, 12-lead ECGs, and laboratory tests.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused drug development company dedicated to the advancement and commercialization of novel treatments for disorders of the heart and circulatory system. Cardiome is traded on the NASDAQ National Market (CRME) and the Toronto Stock Exchange (COM).
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Posted: December 2009