Cardiome has announced positive results from a phase 3 clinical study conducted with vernakalant (Brinavess) in the Asia-Pacific region. The study achieved the primary endpoint, showing that of the 111 treated patients with recent onset atrial fibrillation lasting three hours to seven days, 53% of those receiving an intravenous dose of vernakalant converted to normal heart rhythm within 90 minutes, compared to 12% of placebo patients (95% CI; 23%, 58%, p<0.001).
The study was originally planned to recruit 615 patients, however it was completed after randomising 123 patients. According to a company release, the study remained sufficiently powered.
The study also suggests that vernakalant was generally well-tolerated in the targeted patient population. In the 30 day interval following drug administration, serious adverse events occurred in six (11%) placebo patients and seven (13%) patients dosed with vernakalant. Potentially drug-related serious adverse events occurred in one (2%) patient receiving the antiarrhythmic drug. There were no cases of drug-related torsades de pointes-a well-characterised arrhythmia which is an occasional side effect of many current antiarrhythmic drugs.
In the recent onset atrial fibrillation patients dosed with intravenous vernakalant 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 Asia-Pacific study and to once again see positive consistent results from our Brinavess clinical programme,” says 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 Asia-Pacific study now completed we look forward to working towards applying for Brinavess approvals in Asia-Pacific countries including Taiwan and Korea,” says William Hunter, president and CEO of Cardiome.
The Asia-Pacific study was designed to investigate the safety and efficacy of intravenous vernakalant in patients with recent onset atrial fibrillation lasting three hours to seven days. The primary endpoint was conversion of recent onset atrial fibrillation to normal heart rhythm for a period of at least one minute post-dosing within 90 minutes of the start of dosing. The study was initiated in August 2010, and was carried out in 35 centres in Korea, Taiwan, Hong Kong and India.
Brinavess is approved in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults.