NASDAQ: CORV TSX: CORV
Post Hoc Analysis of Subset of Patients
Treated in the Emergency Department Setting
Safety Outcomes of Interest Observed in Less
Than 1% Cases; No Deaths Reported
Greater Than 70% of Atrial Fibrillation
Episodes Successfully Converted to Sinus Rhythm in a Median Time of
12 Minutes
VANCOUVER, Nov. 18, 2019 /CNW/ - Correvio Pharma Corp.
(NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company
focused on commercializing hospital drugs, today announced the
presentation of new data from the SPECTRUM study evaluating
Brinavess™ (vernakalant hydrochloride, IV), the
Company's antiarrhythmic drug for the rapid conversion of recent
onset atrial fibrillation (AF), in the emergency department setting
at the American Heart Association (AHA) 2019 Annual Meeting taking
place November 16-18, 2019, in
Philadelphia.
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 (SAEs) 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, MD, 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 hospitalization 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 U.S. 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.
Details for the AHA 2019 poster presentations are as
follows:
Title: Rapid cardioversion of recent-onset atrial
fibrillation in the emergency department with vernakalant: Insights
from the multinational SPECTRUM registry
Lead author: Alfonso Martin,
University Hospital Severo Ochoa and University Alfonso,
Madrid, Spain
Poster Board No.: 2028
Session: New insights into atrial and supraventricular
arrhythmias
Date and time: Monday, November 18, 2019; 11:30 a.m. to 12:00 p.m. ET
Location: Zone 2, Science and Technology Hall, Level 2,
Halls A-D
Title: Vernakalant Compared to Anti-arrhythmic Drugs
for Rapid Cardioversion of Early Onset Atrial Fibrillation: A
Meta-analysis
Lead author: Chintan Trivedi, Texas Cardiac Arrhythmia
Institute, Austin, Texas
Poster Board No.: 2132
Session: Pharmacologic Treatment of Arrhythmias
Date and time: Sunday, November 17, 2019; 3:00 p.m. to 3:30 p.m. ET
Location: Zone 2, Science and Technology Hall, Level 2,
Halls A-D
About Atrial Fibrillation
Atrial fibrillation (also known as AFib or AF) is a
supraventricular tachyarrhythmia with uncoordinated atrial
activation resulting in ineffective atrial contraction and if left
untreated, structural and/or electrophysiological atrial tissue
abnormalities.1 AF is a common cardiac rhythm
disturbance that increases in prevalence with advancing
age.1 According to the American Heart Association,
estimates of the prevalence of AF in the U.S. ranged from 2.7
million to 6.1 million in 2010, and is expected to rise to 12
million in 2030.2
There are two strategies to manage AF, namely, rhythm- or
rate-control. A rhythm-control strategy may be used in patients who
are severely compromised, remain symptomatic despite adequate rate
control, when adequate rate control is difficult to achieve, when
long term rhythm control therapy is preferred, younger patient age,
presence of tachycardia-mediated cardiomyopathy, and first episode
of AF.1,3 Early intervention with a rhythm-control
strategy to prevent progression of AF may be particularly
beneficial to the AF patient.1
About Brinavess™
Brinavess (vernakalant HCl, IV) is an antiarrhythmic drug that
acts preferentially in the atria by prolonging atrial
refractoriness and slowing impulse conduction in a rate-dependent
fashion. Brinavess is approved for marketing in Europe, Canada and several other countries worldwide.
In Europe, it is approved for the
rapid conversion of recent onset atrial fibrillation to sinus
rhythm in adults: 1) for non-surgery patients: atrial fibrillation
< 7 days duration; and 2) for post-cardiac surgery patients:
atrial fibrillation <3 days duration. Vernakalant IV is not
approved for use in the United
States.
About Correvio Pharma Corp.
Correvio Pharma Corp. is a specialty pharmaceutical company
focused on providing innovative, high-quality brands that meet the
needs of acute care physicians and patients. With a commercial
presence and distribution network covering over 60 countries
worldwide, Correvio develops, acquires and commercializes brands
for the in-hospital, acute care market segment. The Company's
portfolio of approved and marketed brands includes:
Xydalba™ (dalbavancin hydrochloride), for the treatment
of acute bacterial skin and skin structure infections (ABSSSI);
Zevtera®/Mabelio® (ceftobiprole medocaril
sodium), a cephalosporin antibiotic for the treatment of community-
and hospital-acquired pneumonia (CAP, HAP); Brinavess®
(vernakalant IV) for the rapid conversion of recent onset atrial
fibrillation to sinus rhythm; Aggrastat® (tirofiban
hydrochloride) for the reduction of thrombotic cardiovascular
events in patients with acute coronary syndrome. Correvio's
pipeline of product candidates includes Trevyent®, a
drug device combination that is designed to deliver treprostinil,
the world's leading treatment for pulmonary arterial
hypertension.
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.
References
- January CT et al. 2014 AHA/ACC /HRS guideline for the
management of patients with atrial fibrillation. J AM Coll Cardiol.
2014;34:e1-e76.
- Benjamin EJ et al. Heart Disease and Stroke Statistics-2019
Update: A Report From the American Heart Association. Circulation.
2019 Mar 5;139(10):e56-e528.
- Camm AJ et al. Guidelines for the management of atrial
fibrillation, The Task Force for the Management of Atrial
Fibrillation of the European Society of Cardiology (ESC).
Eur Heart J. 2010;31:2369-2429.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain "forward-looking
statements" within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995 or "forward-looking information"
under applicable Canadian securities legislation (collectively,
"forward-looking statements"). Forward-looking statements include
statements that may relate to our plans, objectives, goals,
strategies, future events, future revenue or performance, capital
expenditures, financing needs and other information that may not be
based on historical fact. Forward-looking statements can often be
identified by the use of terminology such as "believe", "may",
"plan", "will", "estimate", "continue", "anticipate", "intend",
"expect", "look forward to" and similar expressions.
Forward-looking statements are necessarily based on estimates and
assumptions made by us based on our experience and perception of
historical trends, current conditions and expected future
developments, as well as other factors we believe are
appropriate.
By their very nature, forward-looking statements involve known
and unknown risks, uncertainties and other factors that may cause
the actual results, events or developments to be materially
different from any future results, events or developments expressed
or implied by such forward-looking statements. These
forward-looking statements include, but are not limited to,
statements relating to emergency department outcomes for
appropriate AF patients treated with Brinavess as a first line
treatment option being consistent with the overall SPECTRUM
results; the potential for early discharge and lower
hospitalization rates in appropriate AF patients who receive
treatment with Brinavess as a first line treatment option; and, the
approval of Brinavess by the FDA and the timing of any such
approval. In particular, no statement herein should be understood
to mean: (i) that the FDA will find our underlying clinical trial
data to be acceptable; (ii) that the FDA will find our
manufacturing sites acceptable and validate them; or (iii) that our
NDA will ultimately be approved by the FDA. Furthermore, the timing
of any action by the FDA and possible regulatory paths forward
cannot be guaranteed, in that, for example: (i) the FDA may miss
its own required deadlines (including the target action date
assigned under the Prescription Drug User-Fee Act or the date set
for the Advisory Committee meeting); and (ii) the FDA may require
further information or additional clinical studies.
A detailed discussion of the risks and uncertainties facing
Correvio are discussed in the annual report and detailed from time
to time in our other filings with the Securities and Exchange
Commission ("SEC") available at www.sec.gov and the Canadian
securities regulatory authorities at www.sedar.com. In particular,
we direct your attention to Correvio's Annual Report on Form 40-F
for the year ended December 31, 2018
and its quarterly report filed August 14,
2019 for the second quarter of 2019. All of the risks and
certainties disclosed in those filings are hereby incorporated by
reference in their entirety into this news release.
While Correvio makes these forward-looking statements in good
faith, given these risks, uncertainties and factors, you are
cautioned not to place undue reliance on any forward-looking
statements made in this press release. All forward-looking
statements made herein are based on our current expectations and we
undertake no obligation to revise or update such forward-looking
statements to reflect subsequent events or circumstances, except as
required by law. Investors are cautioned that forward-looking
statements are not guarantees of future performance and accordingly
investors are cautioned not to put undue reliance on
forward-looking statements due to their inherent uncertainty.
Correvio® and the Correvio Logo are the proprietary
trademarks of Correvio Pharma Corp.
Aggrastat® and Brinavess™® are trademarks
owned by Correvio and its affiliates worldwide.
Xydalba™ is a trademark of Allergan Pharmaceuticals
International Limited, and used under license.
Zevtera® and Mabelio® are trademarks owned by
Basilea Pharmaceutica International Ltd., and used under
license.
Trevyent® is a trademark of SteadyMed Ltd. and used
under license.
All other trademarks are the property of their respective
owners.
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SOURCE Correvio Pharma Corp