Correvio announced the presentation of new data from the SPECTRUM study evaluating Brinavess (vernakalant hydrochloride, IV), an antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF), at the American Heart Association (AHA) 2019 Annual Meeting (16–18 November; Philadelphia, USA).
SPECTRUM was conducted as part of the follow-up measures agreed to with the European Medicines Agency in 2010 and enrolled 2,009 treatment episodes in 53 participating hospitals in the EU. Brinavess was administered in the emergency department in 64.2% of cases. In this post hoc analysis, 1,289 Brinavess treatment episodes in 1,120 unique patients in the emergency departments were assessed.
The data demonstrated that treatment with Brinavess successfully converted 70.2% (95% confidence interval [CI] 67.5–72.7) of all treated episodes. Treatment with Brinavess also showed a median time to conversion of 12 minutes from start of first infusion among patients who converted. The median length of stay was 7.5 hours in that setting. Only 13% of these emergency department patients remained in hospital for greater than 24 hours.
In the safety results, there were a total of 12 serious adverse events of special interest in 11 patients (0.9%; 95% CI 0.4-1.5%), the most common of which was significant bradycardia (n=9, 0.7%), one of which was associated with significant hypotension (0.1%); two 1:1 atrial flutter (0.2%), one of which was originally differentially evaluated as sustained ventricular tachycardia. No serious Brinavess-related AEs resulted in clinical sequelae and no deaths nor cases of torsades de pointes were reported in the study.
“In the emergency department setting, cardioversion of recent onset AF with vernakalant had a low rate of SAEs of special interest and was highly effective,” said Carin Heringa Correvio’s head of Medical Affairs. “The results from this cohort of the SPECTRUM registry are consistent with the overall SPECTRUM results and support the use of vernakalant as a first line option in appropriate patients, for pharmacologic cardioversion in the emergency department setting. Thus, potentially allowing early discharge and lower hospitalisation rates.”
An additional poster at the meeting describes the evaluation of Brinavess compared to multiple other antiarrhythmic drugs for rapid cardioversion of early onset AF.
A New Drug Application (NDA) for Brinavess is currently under review by the US Food and Drug Administration (FDA) for the conversion of adult patients with recent onset AF. The FDA assigned a target action date of December 24, 2019 under the Prescription Drug User-Fee Act. The FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) is scheduled to review the data supporting Correvio’s NDA on December 10, 2019.