Merck’s Brinavess performs in phase III
pharmafile | May 18, 2010 | News story | Research and Development | Brinavess, Merck & Co, atrial fibrilation
Merck & Co’s heart disorder drug Brinavess has proved superior to rival amiodarone in reducing rates of atrial fibrillation in a phase III trial.
Brinavess (vernakalant) is an investigational compound being developed in the EU by Merck and the Canadian heart disorder specialist Cardiome to offset the effects of atrial fibrillation (AF).
Merck’s agreement with Cardiome gives its affiliate Merck Sharp & Dohme (Switzerland) exclusive rights to Brinavess outside the US.
A phase III study of the drug showed 51.6% of patients on Brinavess IV (intravenous) converted from AF to a normal sinus rhythm within 90 minutes of injection versus 5.2% in the amiodarone group, meeting its primary endpoint.
Secondary endpoints included increasing quality of life (QOL), as measured by the standardised EQ-5D Health Questionnaire two hours after drug administration. These results showed 10.9% of patients on Brivaness IV reported an increase in QOL compared to 5.6% in the amiodarone group.
John Camm, professor of Clinical Cardiology at St George’s, University of London and lead investigator of the AVRO study, said: “Atrial fibrillation is the most common abnormal heart rhythm and its prevalence has increased over the past 20 years.
“It is important to have therapies that convert patients back to a normal heart rhythm as quickly as possible. The efficacy and safety results of vernakalant in this study are encouraging.”
The AVRO trial was a phase III randomised, double-blind, active controlled, double dummy, multi-centre trial that enrolled 254 patients with AF with 232 randomised to receive either Brinavess IV (3mg/kg over 10 minutes followed by 2/mg/kg over 10 minutes if needed after a 15 minute break) or amiodarone (5mg/kg over 60 minutes, followed by 50 mg over 60 minutes until patient converts).
Amiodarone is a widely-used anti-arrhythmia treatment that was first developed in the 1950s. It is generally used as a last choice because of serious side effects that include the potential for liver damage and heart rate disturbances.
Brinavess IV’s main competition would be Sanofi-Aventis’ AF treatment Multaq, which received a limited NICE recommendation in March this year.
An oral version of Brinavess is also being developed for the treatment of AF and is currently in phase II trials.
Ben Adams
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