WINNIPEG, MANITOBA -- (Marketwire) -- 01/08/13 -- Medicure Inc. ("Medicure" or the "Company") (TSX VENTURE: MPH)(PINKSHEETS: MCUJF), is pleased to announce that a supplemental new drug application (sNDA) for the high dose bolus (HDB) dosing regimen of AGGRASTAT® (tirofiban HCl) has been submitted to the United States Food and Drug Administration (FDA). The Company is also pleased to announce that it will receive up to $200,000 in grant funding from the Province of Manitoba Commercialization Support for Business (CSB) Program to complete a renal study evaluating the AGGRASTAT HDB regimen in patients with impaired kidney function.
The sNDA submission requests the addition of the AGGRASTAT HDB regimen (an initial bolus of 25 mcg/kg and then continued at 0.15 mcg/kg/min) to the approved prescribing information for AGGRASTAT. The rationale for the AGGRASTAT HDB regimen is to attain therapeutic platelet inhibition more rapidly than the currently approved dosing regimen (an initial rate of 0.4 mcg/kg/min for 30 minutes and then continued at 0.1 mcg/kg/min). The efficacy and safety of the HDB regimen has been evaluated in more than 30 clinical studies involving over 9,000 patients and is currently recommended by the ACCF/AHA treatment guidelines.(1)
The submission was prepared in consultation with the FDA's Division of Cardiovascular and Renal Drug Products.
Additionally, the Company is conducting a renal dosing study in volunteers receiving the AGGRASTAT 25 mcg/kg bolus dose. The results of this study will be submitted to the FDA separately to guide appropriate dosing recommendations for the HDB regimen in patients with impaired kidney function.
Up to $200,000 funding for this study will be provided by the Province of Manitoba's CSB Program. This Program assists Manitoba entrepreneurs and businesses seeking to develop and commercialize innovative products and processes, and expand into new markets.
"The sNDA submission is an important part of our clinical and regulatory strategy to improve Aggrastat's position within the contemporary market," stated Dawson Reimer, President and COO of Medicure Inc. "The Province of Manitoba's CSB Program is not only important for Medicure's sNDA but has also been helpful for the local life science community as a whole and we are pleased to be working with them in this way."
AGGRASTAT (tirofiban HCl), in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing PTCA or atherectomy. In this setting, AGGRASTAT has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction or refractory ischemia/repeat cardiac procedure. AGGRASTAT has been studied in a setting that included aspirin and heparin.
Bleeding is the most common complication encountered during therapy with AGGRASTAT. Administration of AGGRASTAT is associated with an increase in bleeding events classified as both major and minor bleeding events by criteria developed by the Thrombolysis in Myocardial Infarction Study group (TIMI). Most major bleeding associated with AGGRASTAT occurs at the arterial access site for cardiac catheterization. Fatal bleedings have been reported. AGGRASTAT should be used with caution in patients with platelet count less than 150,000/mm3, in patients with hemorrhagic retinopathy, and in chronic hemodialysis patients. Because AGGRASTAT inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostasis. The safety of AGGRASTAT when used in combination with thrombolytic agents has not been established. During therapy with AGGRASTAT, patients should be monitored for potential bleeding. When bleeding cannot be controlled with pressure, infusion of AGGRASTAT and heparin should be discontinued.
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