Cardiome reports positive Phase III A-P trial results of Brinavess in AF patients

9th November 2014 (Last Updated November 9th, 2014 18:30)

Canada-based Cardiome Pharma has reported positive results from a Phase III clinical trial of Brinavess (vernakalant intravenous, RSD 1235) to treat patients with atrial fibrillation (AF) in the Asia-Pacific (A-P) region.

Canada-based Cardiome Pharma has reported positive results from a Phase III clinical trial of Brinavess (vernakalant intravenous, RSD 1235) to treat patients with atrial fibrillation (AF) in the Asia-Pacific (A-P) region.

Originally, the trial was planned to enrol 615 patients, however it was completed after randomising 123 patients with Brinavess.

The trial remained sufficiently powered and it achieved the primary endpoint, showing that of the 111 treated patients with recent-onset AF lasting three hours to seven days, 53% of those receiving an IV dose of Brinavess converted to normal heart rhythm within 90 minutes, compared to 12% of placebo patients.

The results show that Brinavess was generally well-tolerated in the targeted patient population.

"Originally, the trial was planned to enrol 615 patients, however it was completed after randomising 123 patients with Brinavess."

In the 30 day interval after drug administration, serious adverse events were seen in six placebo patients and seven patients dosed with Brinavess.

The median time to conversion was 11 minutes from the start of infusion in the recent-onset AF patients dosed with intravenous Brinavess who converted to normal heart rhythm within 90 minutes.

Cardiome medical director Dr Steen Juul-Möller said: "The results from this study provide additional support for rapid and effective cardioversion combined with high level of safety as observed in Brinavess Phase III clinical studies; ACT I and ACT III."

The trial, designed to evaluate the safety and efficacy of intravenous Brinavess in patients with recent-onset AF lasting three hours to seven days, was carried out in 35 centres in Korea, Taiwan, Hong Kong and India.

Primary endpoint in the trial was conversion of recent-onset AF to normal heart rhythm for a period of at least one minute post-dosing within 90 minutes of the start of dosing.

Cardiome president and CEO William Hunter said: "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.

"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."