AntiOp Inc., a Kentucky company, has sold its lead product technology – an intranasal naloxone hydrochloride nasal spray designed to treat opioid overdoses – to Indivior PLC, which will complete development and commercialize the product.
AntiOp founder and CEO Daniel Wermeling, professor of pharmacy at the University of Kentucky, said in a company press release that Indivior is uniquely suited to bring the product to market and potentially help opioid overdose victims.
A new drug application was recently submitted for the product to the U.S. Food and Drug Administration. The product, intended for the emergency treatment of suspected opioid overdose, also received “Fast Track” designation from the U.S. Food and Drug Administration last year. The Fast Track program of the FDA is designed to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
“We believe that our simple treatment can be an additional tool in dealing with opioid overdoses and can help address this growing epidemic,” Wermeling said. “Selling the technology to an established company with robust capabilities to complete the product’s development, market it and distribute it means it will reach those who need it as quickly as possible.”
Deaths due to painkiller (primarily opioids) overdose in the United States have quadrupled since 1999, according to the Centers for Disease Control and Prevention. More than 16,000 deaths occur in the U.S. each year from prescription opioids. A new ready-to-use, needle-free, naloxone delivery system may provide medical providers and their patients more options to rescue a loved one, Wermeling said.
Wermeling added that AntiOp received support from the National Institutes of Health and its National Institute on Drug Abuse, which provided grant funding to advance development of the naloxone nasal spray. The Kentucky Science and Technology Corp., part of the Kentucky Economic Development Cabinet, also provided grant funding. Total federal and state grant funding to date exceeds $5 million, almost $4.5 million of that from the NIDA.
The University of Kentucky Colleges of Pharmacy and Medicine and the National Institutes of Health Center for Clinical and Translational Science were also instrumental to development of the product, Wermeling said.