Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced results from a Phase 3 clinical study conducted with BRINAVESS® (vernakalant intravenous, RSD 1235) in the Asia-Pacific (A-P) region. The study was originally planned to recruit 615 patients, however the study was completed after randomising 123 patients. The study remained sufficiently powered and it achieved the primary endpoint, showing that of the 111 treated patients with recent-onset atrial fibrillation (AF) lasting 3 hours to 7 days, 53% of those receiving an IV dose of BRINAVESS converted to normal heart rhythm within 90 minutes, compared to 12% of placebo patients (95% CI; 23%, 58%, p<0.001).
The A-P study data suggests that BRINAVESS was generally well-tolerated in the targeted patient population. In the 30 day interval following drug administration, serious adverse events occurred in 6 (11%) placebo patients and 7 (13%) patients dosed with BRINAVESS. Potentially drug-related serious adverse events occurred in 1(2%) patient receiving BRINAVESS. There were no cases of drug-related torsades de pointes, a well-characterized arrhythmia which is an occasional side effect of many current antiarrhythmic drugs.
In the recent-onset AF patients dosed with intravenous BRINAVESS who converted to normal heart rhythm within 90 minutes, the median time to conversion was 11 minutes from the start of infusion.
"We are pleased to have completed the A-P study and to once again see positive consistent results from our BRINAVESS clinical program," stated Dr. Steen Juul-Möller, Cardiome's Medical Director. "The results from this study provide additional support for rapid and effective cardioversion combined with high level of safety as observed in BRINAVESS Phase 3 clinical studies; ACT I and ACT III."
"With the A-P study now completed we look forward to working towards applying for BRINAVESS approvals in Asia-Pacific countries including Taiwan and Korea," stated William Hunter, M.D., President and CEO of Cardiome. "We are committed to making BRINAVESS available in all key worldwide markets. The results from this study put us one step closer to achieving this goal in the Asia-Pacific region."
The A-P study was designed to investigate the safety and efficacy of intravenous BRINAVESS in patients with recent-onset atrial fibrillation lasting 3 hours to 7 days. The primary endpoint in A-P was conversion of recent-onset AF to normal heart rhythm for a period of at least 1 minute post-dosing within 90 minutes of the start of dosing. The study was initiated in August 2010, and was carried out in 35 centers in Korea, Taiwan, Hong Kong and India.
Study: 40% of newly diagnosed heart failure patients also have atrial fibrillation