WINNIPEG, MB, Jan. 27, 2021
/CNW/ - Medicure Inc. ("Medicure" or the "Company") (TSXV: MPH)
(OTC: MCUJF), a cardiovascular pharmaceutical company, is pleased
to announce the early completion of iSPASM, a randomized,
double-blind, single-center, Phase 1/2a trial aimed at
assessing the safety of long-term (7-day) use of
AGGRASTAT® (tirofiban hydrochloride) injection (an
intravenous GP IIb/IIIa inhibitor) vs. placebo in patients with
aneurysmal subarachnoid hemorrhage (aSAH) (NCT03691727). The
primary endpoint in the 30 patient study was hemorrhagic changes
evident on head CT and/or MRI assessed by the rates of symptomatic
and asymptomatic bleeding.
"Medicure is gratified and encouraged by the results of the
trial led Dr. David Hasan, MD,
Professor of Neurosurgery at University of
Iowa Hospitals and Clinics, and the trial's principal
investigator. His work is an important step in the exploration of
the use of parenteral IV antiplatelet therapy in the management of
aSAH in stroke patients.", said Albert D.
Friesen, PhD, CEO of Medicure and Chair of its Board of
Directors. Dr. Hasan expects to release top-line data and present
the results at an upcoming conference with a manuscript to
follow.
Dr. Hasan states, "The results of iSPASM are very promising. The
trial is the first of its kind as it showed in a well-designed,
randomized controlled trial that using continuous IV infusion of
AGGRASTAT® appears to be safe in patients with
ruptured intracranial aneurysms (stroke). Results from this study
pave the way for a Phase 2 trial which will be focused on efficacy.
A positive outcome will be groundbreaking in the management of
these patients. Interventionalists who treat patients with this
condition using stents or flow diverters could use
AGGRASTAT® as the choice of antiplatelet therapy to
prevent clotting and further ischemic stroke. We are very grateful
for the sponsorship and partnership with Medicure for making this
trial happen to benefit our patients."
iSPASM was funded by an unrestricted educational grant from
Medicure. This study does not imply efficacy of
AGGRASTAT® in patients with aSAH. Please note that
the use of AGGRASTAT® in neurointerventions 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 stroke 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.1 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 and
ZYPITAMAG® (pitavastatin) tablets in the United States, where they are sold through
the Company's U.S. subsidiary, Medicure Pharma Inc. Medicure also
operates Marley Drug, Inc. ("Marley"), a pharmacy located in
North Carolina that offers an
Extended Supply mail order drug program serving all 50 states,
Washington D.C. and Puerto Rico. Marley is committed to improving
the health status of their patients and the communities they serve
while reducing overall health care costs for employers and other
health care consumers. For more information visit
http://www.marleydrug.com. To learn more about The Extended Supply
Generic Drug Program call 800.286.6781 or email
marleydrug@bellsouth.net. For more information on Medicure please
visit www.medicure.com. For additional information about
AGGRASTAT®, refer to the full Prescribing Information.
For additional information about ZYPITAMAG®, refer to
the full Prescribing Information.
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.
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
results, including future revenue from P5P, the likelihood of
receiving a PRV, 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® (tirofiban hydrochloride) injection is a
registered trademark of Medicure International Inc.
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