WINNIPEG, MB, June 15, 2020 /CNW/ - Medicure Inc.
("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF),
a pharmaceutical company, is pleased to announce that on
Saturday, June 27, 2020, Dr. Marco
Valgimigli, MD, PhD, Professor of Cardiology, Director of Clinical
Research at Bern University Hospital, will present the results of
the FABOLUS-FASTER Phase 4 clinical trial. The FABOLUS-FASTER trial
was designed to assess different regimens of intravenous platelet
inhibitors, notably AGGRASTAT® (tirofiban hydrochloride)
injection (an IV GP IIb/IIIa inhibitor) and cangrelor (an IV P2Y12
inhibitor) in the early phase of primary PCI. Dr. Valgimigli's
presentation will take place during a late-breaking trial session
at the PCR e-Course 2020, on Saturday, June 27 at 9:00 am CET / 3:00 am
EDT.
FABOLUS-FASTER is a randomized, open-label, multi-center trial
comparing AGGRASTAT® to cangrelor in patients with
ST-elevation myocardial infarction referred for PCI*. A total of
120 subjects were randomized to receive AGGRASTAT®,
cangrelor, chewed or integer prasugrel at the beginning of primary
PCI.
- Presentation of FABOLUS-FASTER Trial Results by Dr. Marco
Valgimigli:
9:00 am
CET / 3:00 am EDT on Saturday,
June 27 at the PCR e-Course 2020, Late Breaking Trials, Session
"STEMI Interventions: First-In-Man and Novel Pharmacological
Strategies", virtual meeting. To register and participate in the
PCR e-Course, click here:
https://www.pcronline.com/Courses/PCR-e-Course
The content will remain available
on replay during and after the e-Course.
Complete results from this study have been accepted for
publication in Circulation, a peer-reviewed journal of the American
Heart Association.
Additional Details About the Study
FABOLUS-FASTER was
funded by a grant from Medicure. This study does not imply
comparable efficacy, safety, or product interchangeability. *Please
note that the use of AGGRASTAT® in STEMI patients
has not been approved by the FDA. As of this time, neither
AGGRASTAT® nor any of the GP IIb/IIIa inhibitors
are indicated for the use in STEMI patients.
AGGRASTAT® is approved for use in NSTE-ACS
patients. Refer to Important Safety Information below and the U.S.
Prescribing Information for complete product information. For
additional information about FABOLUS-FASTER, please visit
https://clinicaltrials.gov/ct2/show/NCT02978040
About
AGGRASTAT®
AGGRASTAT® is
an IV antiplatelet medication indicated to reduce the rate of
thrombotic cardiovascular events (combined endpoint of death,
myocardial infarction, or refractory ischemia/repeat cardiac
procedure) in patients with non-ST elevation acute coronary
syndrome (NSTE-ACS). AGGRASTAT® is currently the
most widely used GP IIb/IIIa inhibitor in the U.S.2 and
has several administration benefits including room temperature
storage, a 3-year shelf life and is available in pre-mixed formats.
Please refer to the IMPORTANT SAFETY INFORMATION below.
About Medicure Inc.
Medicure is a pharmaceutical
company focused on the development and commercialization of
therapies for the U.S. cardiovascular market. The present focus of
the Company is the marketing and distribution of
AGGRASTAT® (tirofiban hydrochloride) injection,
ZYPITAMAGTM (pitavastatin) tablets and the ReDS™ device
in the United States, where they
are sold through the Company's U.S. subsidiary, Medicure Pharma
Inc. For more information on Medicure please visit
www.medicure.com.
Important Safety Information for AGGRASTAT®
(tirofiban hydrochloride)
Indications and Usage
AGGRASTAT® is indicated to reduce the rate of
thrombotic cardiovascular events (combined endpoint of death,
myocardial infarction, or refractory ischemia/repeat cardiac
procedure) in patients with non-ST elevation acute coronary
syndrome (NSTE-ACS).
Dosage and Administration
Administer intravenously 25 mcg/kg within 5 minutes and then
0.15 mcg/kg/min for up to 18 hours. In patients with creatinine
clearance ≤60 mL/min, give 25 mcg/kg within 5 minutes and then
0.075 mcg/kg/min.
Contraindications
Known hypersensitivity to any component of
AGGRASTAT®, history of thrombocytopenia with prior
exposure to AGGRASTAT®, active internal bleeding, or
history of bleeding diathesis, major surgical procedure or severe
physical trauma within previous month.
Warnings and Precautions
AGGRASTAT® can cause serious bleeding. Most
bleeding associated with AGGRASTAT® occurs at the
arterial access site for cardiac catheterization. Minimize the use
of traumatic or potentially traumatic procedures such as arterial
and venous punctures, intramuscular injections, nasotracheal
intubation, etc. Concomitant use of fibrinolytics, anticoagulants
and antiplatelet drugs increases the risk of bleeding. If bleeding
cannot be controlled, discontinue AGGRASTAT®.
Thrombocytopenia: Discontinue AGGRASTAT® and
heparin.
Adverse Reactions
Bleeding is the most commonly reported adverse reaction.
For more information on AGGRASTAT®, please refer to
Full Prescribing Information available
at www.aggrastatHDB.com.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.
To be added to Medicure's e-mail list, please
visit:
http://medicure.mediaroom.com/alerts
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of
this release.
Forward Looking Information: Statements contained in this
press release that are not statements of historical fact,
including, without limitation, statements containing the words
"believes", "may", "plans", "will", "estimates", "continues",
"anticipates", "intends", "expects" and similar expressions, may
constitute "forward-looking information" within the meaning of
applicable Canadian and U.S. federal securities laws (such
forward-looking information and forward-looking statements are
hereinafter collectively referred to as "forward-looking
statements"). Forward-looking statements, include estimates,
analysis and opinions of management of the Company made in light of
its experience and its perception of trends, current conditions and
expected developments, as well as other factors which the Company
believes to be relevant and reasonable in the circumstances.
Inherent in forward-looking statements are known and unknown risks,
uncertainties and other factors beyond the Company's ability to
predict or control 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, and as such, readers are cautioned not to place undue
reliance on forward-looking statements. Such risk factors include,
among others, the Company's future product revenues, expected
future growth in revenues, stage of development, additional capital
requirements, risks associated with the completion and timing of
clinical trials and obtaining regulatory approval to market the
Company's products, the ability to protect its intellectual
property, dependence upon collaborative partners, changes in
government regulation or regulatory approval processes, and rapid
technological change in the industry. Such statements are based on
a number of assumptions which may prove to be incorrect, including,
but not limited to, assumptions about: general business and
economic conditions; the impact of changes in Canadian-US dollar
and other foreign exchange rates on the Company's revenues, costs
and results; the timing of the receipt of regulatory and
governmental approvals for the Company's research and development
projects; the availability of financing for the Company's
commercial operations and/or research and development projects, or
the availability of financing on reasonable terms; results of
current and future clinical trials; the uncertainties associated
with the acceptance and demand for new products and market
competition. The foregoing list of important factors and
assumptions is not exhaustive. The Company undertakes no obligation
to update publicly or otherwise revise any forward-looking
statements or the foregoing list of factors, other than as may be
required by applicable legislation. Additional discussion regarding
the risks and uncertainties relating to the Company and its
business can be found in the Company's other filings with the
applicable Canadian securities regulatory authorities or the US
Securities and Exchange Commission, and in the "Risk Factors"
section of its Form 20F for the year ended December 31, 2019.
AGGRASTAT® is a registered trademark of Medicure
International Inc.
References
1 https://clinicaltrials.gov/ct2/show/NCT02978040
2 Data on file
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SOURCE Medicure Inc.