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news.Brinavess (vernakalant) intravenous, an investigational compound being developed in the European Union by Merck and Cardiome Pharma to treat atrial fibrillation, showed that Brinavess was superior to amiodarone injection, in converting patients' heart rate from atrial fibrillation (AF) to sinus rhythm (SR) within 90 minutes of the start of administration, according to a new Phase III study.
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Merck and Cardiome Pharma have presented the results of the Brinavess study during a late-breaking clinical trials session at Heart Rhythm 2010, the annual meeting of the Heart Rhythm Society.
Brinavess is being developed in two formulations, oral and IV, for the treatment of atrial fibrillation. Brinavess in the IV formulation is currently under review in the EU. Brinavess in the oral formulation is being developed for daily maintenance of normal heart rhythm in patients with atrial fibrillation to prevent reoccurrence of atrial fibrillation.
In the study called AVRO (Active-Controlled, Multi-Center Study of Vernakalant Injection versus Amiodarone in Subjects with Recent Onset Atrial Fibrillation), 51.7% of patients on Brinavess converted from atrial fibrillation to normal sinus rhythm within 90 minutes, versus 5.2% in the amiodarone group. The median time to conversion in patients who responded to Brinavess was 11 minutes.
John Camm, lead investigator of the AVRO study, said: “The efficacy and safety results of vernakalant in this study are encouraging.”