The 28-month contract, a follow-on option to a contract begun in 2011, will include development of additional clinical supplies, regulatory filings and testing in two animal models to show safety and efficacy to support FDA approval.
SwRI Microencapsulation and Nanomaterials department principal investigator and director Dr Joe McDonough noted that this antidote could potentially save many lives in an emergency situation by allowing individuals to quickly administer — even self-administer — a life saving dosage of the isoamyl nitrite intranasally.
"This formulation, using a nasal delivery method, is relatively low-cost and can be quickly and easily administered in a crisis situation unlike the current method that must be delivered by a trained medical professional," Dr McDonough added.
In 2011, BARDA awarded SwRI a $4.4m contract to develop a drug formulation and delivery system to treat cyanide exposure.
During the base period of SwRI’s contract, nasal delivery of isoamyl nitrite was shown to be surprisingly effective at treating and rapidly reversing otherwise lethal cyanide exposure during nonclinical testing, according to McDonough.