Medicure Inc. announced that a supplemental new drug application for the high dose bolus dosing regimen of AGGRASTAT (tirofiban HCl) has been submitted to the United States Food and Drug Administration. 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 products and processes, and expand into new markets.