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TextWINNIPEG, Dec. 12, 2019 /PRNewswire/ – Medicure Inc. (“Medicure” or the “Company”) (TSXV: MPH), (OTC: MCUJF), a cardiovascular pharmaceutical company, is pleased to announce the completion of the FABOLUS-FASTER Phase 4 trial, a randomized, open-label, multi-center trial assessing different regimens of intravenous platelet inhibitors, notably tirofiban (an IV GP IIb/IIIa inhibitor) and cangrelor (an IV P2Y12 inhibitor) in the early phase of primary PCI. The study enrolled 120 patients. Medicure expects to release top-line data in Q1 of 2020.
“We are very pleased with the completion of enrollment of FABOLUS-FASTER. Medicure is proud to support innovative and contemporary clinical research involving Aggrastat, in particular sponsoring leading cardiologists such as Dr. Marco Valgimigli”, said Albert Friesen, PhD, CEO of Medicure.
Marco Valgimigli, MD, PhD, Professor of Cardiology, Director of Clinical Research at Bern University Hospital, and principle investigator for the trial, stated, “We are extremely proud to have reached the completion of patient inclusion in this trial which, we believe, will be very informative for clinicians as it will provide unique comparative data regarding the potency and consistency of platelet inhibition among STEMI patients across available antiplatelet treatment options.”
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™ 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.
To be added to Medicure’s e-mail list, please visit: http://medicure.mediaroom.com/alerts
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