FDA Approves Labeling
Supplement
WINNIPEG, April 23, 2015 /PRNewswire/ - Medicure Inc.
("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF),
a specialty pharmaceutical company, is pleased to announce that the
United States Food and Drug Administration (FDA) has approved a
revision to the duration of the bolus delivery for the
AGGRASTAT® (tirofiban HCl) high-dose bolus (HDB)
regimen.
The dosing change and label modification was requested by the
Company to help health care professionals more efficiently meet
patient-specific administration needs and to optimize the
implementation of AGGRASTAT at new hospitals. The newly approved
labeling supplement now allows the delivery duration of the
AGGRASTAT high-dose bolus (25 mcg/kg) to occur anytime within 5
minutes, instead of the previously specified duration of 3
minutes. This change is part of Medicure's ongoing regulatory
strategy to expand the applications for AGGRASTAT.
"We believe the revised dosing time window will offer health
care professionals greater flexibility in the administration of
AGGRASTAT, allowing the duration of the bolus dose to be tailored
to the needs of the patient," stated Dawson
Reimer, President and Chief Operating Officer, Medicure
Inc. "As AGGRASTAT utilization continues to expand across
the United States, the label
modification is part of our strategy to best position our product
in the evolving field of interventional cardiology."
The AGGRASTAT HDB regimen was originally approved by the FDA in
October 2013 as a part of the
Company's supplemental New Drug Application (sNDA). The total
bolus dose (25 mcg/kg), maintenance infusion (0.15 mcg/kg/min) and
indication for AGGRASTAT have not been modified as a part of the
labeling supplement. With the FDA approval letter announced
today, the infusion duration for delivery of the bolus in the
AGGRASTAT prescribing information has been changed from "over 3
minutes" to "within 5 minutes".
About Medicure Inc.
Medicure is a specialty pharmaceutical company focused on the
development and commercialization of therapeutics for the U.S.
hospital market. The primary focus of the Company and its
subsidiaries is the marketing and distribution of AGGRASTAT
(tirofiban HCl) for non-ST elevation acute coronary syndrome in
the United States, where it is
sold through the Company's U.S. subsidiary, Medicure Pharma,
Inc. For more information on Medicure please visit
www.medicure.com.
About AGGRASTAT
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.
Warnings and Precautions
Bleeding is the most common
complication encountered during therapy with AGGRASTAT. Most
bleeding associated with AGGRASTAT occurs at the arterial access
site for cardiac catheterization. Minimize the use of traumatic or
potentially traumatic procedures such arterial and venous
punctures, intramuscular injections, nasotracheal intubation, etc.
Fatal bleeding events have been reported. Concomitant use of
fibrinolytics, oral anticoagulants and antiplatelet drugs increases
the risk of bleeding.
Profound thrombocytopenia has been reported with AGGRASTAT.
Monitor platelet counts beginning about 6 hours after treatment
initiation and daily thereafter. If the platelet count decreases to
<90,000/mm3, monitor platelet counts to exclude
pseudothrombocytopenia. If thrombocytopenia is confirmed,
discontinue AGGRASTAT and heparin. Previous exposure to a
glycoprotein (GP) IIb/IIIa receptor antagonist may increase the
risk of developing thrombocytopenia.
Please refer to Full Prescribing Information.
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, including the expectation
of continued growth in sales of AGGRASTAT and any benefit of the
announced label change to hospitals and health care professionals
using or intending to use AGGRASTAT, are based on the current
assumptions, 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, 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 seven month fiscal year ended
December 31, 2014.
AGGRASTAT® (tirofiban HCl) is a registered trademark of
Medicure International, Inc.
SOURCE Medicure Inc.