Medicure Files Application for New AGGRASTAT® Product Format

Expects to Launch Bolus Vial in Q3 2016

WINNIPEG, Medicure Inc., a specialty pharmaceutical company, is pleased to announce that it has submitted an application to the U.S. Food and Drug Administration (FDA) for the introduction of a new "bolus vial" product format for AGGRASTAT (tirofiban HCl).  

The new product format is a concentrated, pre-mixed, 15 ml vial containing sufficient drug to administer the FDA approved, high dose bolus (HDB) of 25 mcg/kg at the beginning of treatment. AGGRASTAT is currently only sold in a pre-mixed intravenous bag format that comes in two sizes, 100 ml and 250 ml.  The existing, pre-mixed products will continue to be available, providing a convenient concentration for administering the post-HDB maintenance infusion of 0.15 mcg/kg/min. (Approved Dosing: Administer intravenously 25 mcg/kg within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours.)

"Our decision to pursue the new bolus vial format is in response to feedback we have received from hospitals considering a switch to AGGRASTAT," stated Dr. Albert Friesen, Chief Executive Officer and President at Medicure Inc. "If the application is approved, we anticipate the launch of the new product format in Q3 2016, and we expect that this investment in our brand will make a significant contribution as we seek to further expand use of AGGRASTAT across the United States."

Although the current bag format can be used to deliver the HDB as well as the maintenance infusion, some physicians and hospital catheterization labs prefer to administer the initial bolus dose with a smaller volume of drug product.  Moreover, the availability of a ready-to-use bolus vial will provide greater operational similarities and efficiencies for hospitals transitioning to AGGRASTAT.

As is the case with the existing bag format, the new AGGRASTAT bolus vial does not require refrigeration and has a relatively neutral acidity (pH 5.5 – 6.5). 

Development costs, and the cost of the initial commercial inventory, of the new bolus vial were substantially incurred in 2015.

The launch of the new product format is dependent upon approval by the FDA. Expected FDA review time is four (4) months.

Source: Medicure Inc.