Safety Outcomes of Interest Observed in Less Than 1% Cases; Zero Deaths Reported
Greater Than 70% of Atrial Fibrillation Episodes Successfully Converted to Sinus Rhythm in a Median Time of 12 Minutes
NASDAQ: CORV TSX: CORV
VANCOUVER, Sept. 3, 2019 /CNW/ - Correvio Pharma Corp. (NASDAQ:CORV) (TSX:CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced the presentation of results from the SPECTRUM study evaluating Brinavess® (vernakalant hydrochloride, IV), the Company's antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF), at the European Society of Cardiology (ESC) 2019 Congress taking place August 31 – September 4, 2019, in Paris, France.
SPECTRUM was conducted as part of the follow-up measures agreed to with the European Medicines Agency in 2010. In this prospective and retrospective, international, multicenter, observational registry, 1,778 unique patients with 2,009 treatment episodes were enrolled to describe patients receiving Brinavess and to characterize normal conditions of use and dosing, and quantify possible medically significant risks associated with the use of Brinavess in real-world clinical practice. The data for SPECTRUM was provided by 53 participating hospitals in the EU and demonstrated that treatment with Brinavess successfully converted 70.2% (95% confidence interval [CI] 68.1 – 72.2) 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. Cardioversion to sinus rhythm was 70.4% and 65.4% of treatment episodes in non-surgery and post-cardiac surgery patients, respectively. Brinavess was administered in the emergency department in 64.2% of cases, with a median stay of 7.5 hours in that setting.
In the safety results, a total of 19 health outcomes of interest ("HOIs", defined as significant hypotension, significant ventricular arrhythmia, atrial flutter with 1:1 conduction, or significant bradycardia) were reported in 17 of the 1778 patients enrolled (<1%). The cumulative incidence of HOIs at study completion was 0.8% (95% CI: 0.5%-1.4%). Twenty-eight serious adverse events (SAEs, including the 19 HOIs) were reported for 26 patients and no cases of torsades de pointes, ventricular fibrillation or deaths were reported in the study.
"This large European registry provides important data on the safety, efficacy and use of Brinavess in a real-world clinical setting. In SPECTRUM, normal heart rhythm was restored in over 70% of patients at a median time of 12 minutes," said Juha Hartikainen, M.D., Cardiologist and Professor of Medicine, Kuopio University Hospital, and co-author of the presentation. "Importantly, Brinavess may provide rapid cardioversion without the need of anesthesia. Time is of the essence in the treatment of recent-onset atrial fibrillation."
A New Drug Application for Brinavess is currently under review by the U.S. Food and Drug Administration 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.
Details for the ESC 2019 poster presentation are as follows:
About Atrial Fibrillation
About Brinavess®
About Correvio Pharma Corp.
Correvio is traded on the NASDAQ Capital Market (CORV) and the Toronto Stock Exchange (CORV). For more information, please visit our web site www.correvio.com.
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SOURCE Correvio Pharma Corp
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