WINNIPEG, MB, June 29, 2020 /CNW/ - Medicure Inc.
("Medicure" or the "Company") (TSXV: MPH) (OTC:
MCUJF), a pharmaceutical company, today announced that results from
the investigator sponsored FABOLUS-FASTER Phase 4 clinical trial,
using AGGRASTAT®, have been published in
Circulation, a peer-reviewed journal of the American Heart
Association.
FABOLUS-FASTER studied 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.
"The results published in Circulation are the first to compare
the pharmacodynamic effects of cangrelor, with
AGGRASTAT®, as well as the pharmacodynamic and
pharmacokinetic effects of a chewed or integral pill of prasugrel,"
said Dr. Albert D. Friesen, CEO of
Medicure. "We are pleased with the performance of
AGGRASTAT® in the FABOLUS-FASTER trial against
cangrelor and look forward to its continued growth as part of our
portfolio of cardiovascular products."
The FABOLUS-FASTER study randomized 122 P2Y12-naive STEMI
patients to receive tirofiban (n=40), cangrelor (n=40), or a 60 mg
loading dose of prasugrel (n=42). Those randomized to prasugrel
were sub-randomized to chewed (n=21) or integral (n=21) tablet
administration. The study was powered to test the noninferiority of
cangrelor compared with tirofiban, the superiority of both
tirofiban and cangrelor compared with chewed prasugrel, and
superiority of chewed prasugrel compared with integral prasugrel
for the primary endpoint of 30-minute inhibition of platelet
aggregation (IPA) after stimulation with (20 µmol/L) ADP.
The results from the FABOLUS-FASTER trial showed cangrelor did
not reach non-inferiority with tirofiban; in fact, tirofiban
achieved superior IPA over cangrelor at 30 minutes (95.0%±9.0% vs
34.1%±22.5%; P <0.001). Cangrelor and tirofiban were both
superior to chewed prasugrel (10.5%±11.0%, P<0.001 for both
comparisons), which did not provide higher IPA over integral
prasugrel (6.3%±11.4%; P=0.47).1
Results from FABOLUS-FASTER were recently presented virtually at
the PCR e-Course Scientific Sessions, due to the cancellation of
EuroPCR 2020. Complete results from this study were published on
June 27, 2020 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.
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™ PRO
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
- Gargiulo G, Esposito G, Avvedimento M, et al. Cangrelor,
Tirofiban and Chewed or Standard Prasugrel Regimens in Patients
with ST-Segment Elevation Myocardial Infarction: Primary Results of
the FABOLUS FASTER Trial. Circulation. 2020.
doi:10.1161/circulationaha.120.046928
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SOURCE Medicure Inc.