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.
“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,” said Joe McDonough, Principal Investigator and director of SwRI’s microencapsulation and nanomaterials department. “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.”
Cyanide exposure can prove lethal if not treated quickly and effectively. Current antidotes require intravenous administration, which does not enable quick treatment of large numbers of victims, such as in a terrorist situation. A nasal formulation could potentially save lives by allowing for rapid treatment of large numbers of patients and administration of metered dosages.
In 2011, BARDA awarded SwRI $4.4 million 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, said McDonough.
“This is just one more program in SwRI’s 10-year effort to develop antidotes against toxic industrial chemicals and chemical weapons,” said Michael MacNaughton, vice president of the chemistry and chemical engineering division. “SwRI has a long history of developing new technology to support the government.”
