Merck & Co/Cardiome's Brinavess shows superiority to amiodarone in Ph III AF trial; Zostavax safety confirmed

US drug giant Merck & Co says that a new Phase III study with Brinavess (vernakalant) intravenous, an investigational compound being developed in the European Union by its subsidiary Merck Sharp & Dohme to treat atrial fibrillation, showed that the drug 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.

The results of the study were presented during a late-breaking clinical trials session at Heart Rhythm 2010, held in Colorado, Denver, USA, last week. Brinavess was licensed from Vancouver, Canada-based Cardiome Pharma in April last year for markets outside the North America, in a deal that could generate payments of up to $600 million for the latter firm.

In the study, called AVRO (Active-Controlled, Multi-Center Study of Vernakalant Injection versus Amiodarone in Subjects with Recent Onset Atrial Fibrillation), 51.7% (n=116) of patients on Brinavess converted from atrial fibrillation to normal sinus rhythm within 90 minutes, versus 5.2% (n=116) in the amiodarone group (p<0.0001). the median time to conversion in patients who responded to brinavess was 11 minutes.>