The anti-overdose nasal spray developed in Lexington as a front-line weapon to combat heroin overdoses has been bought by a biotech firm and could be on the market within six months.
The timing depends on approval by the U.S. Food and Drug Administration which has put it on a fast track, said inventor Daniel Wermeling, a pharmacy professor at the University of Kentucky. The sale of Wermeling's product — intranasal naloxone hydrochloride nasal spray — was announced Wednesday.
The device, created by Wermeling's Kentucky-based company, AntiOp Inc., contains a single dose of a mist form of naloxone and delivers the drug in a way similar to how Flonase is used to treat allergies. It was bought by Indivior PLC, a spin-off of the pharmaceutical company Reckitt Benckiser. It manufactures Suboxone, which is designed to wean addicts from heroin and other opiates.
Wermeling couldn't say when his product might be available. But another fast-track anti-overdose therapy, an injectable, was approved by the FDA last month after just 14 weeks, he said. The FDA fast-track program expedites the development of drugs that address unmet medical needs in the treatment of serious or life-threatening conditions.
Wermeling has worked on the project at UK since 2009. His efforts were supported by more than $5 million in federal and state tax dollars.
Financial details of the deal between AntiOp and Indivior were private, he said, but UK received $2 million directly from grants used to develop the product. And UK received $400,000 this year as a percentage of the sale, he said.
Further payments to the university are tied to other milestones as the product is marketed and developed. Wermeling also said $650,000 in state grant money to AntiOp has been paid back because it was intended to foster development in Kentucky, and Indivior is based out of state.
Because of its national and international profile, Indivior has the ability to manufacture, market and distribute the product, said UK Provost Tim Tracy.
Currently, emergency responders and hospitals have to draw naloxone — also called Narcan — in a syringe to administer the right dose, Tracy said.
The investment of tax money into the research for Wermeling's nasal spray by the National Institute of Drug Abuse and the support by the university helped make the broad use of the therapy available for public use, Tracy explained.
"It is the success story of a great partnership," Tracy said.
The rising rates of heroin overdoses across the country are part of the reason the drug is on the fast track for FDA approval, Tracy said.
Heroin overdose has been on the rise in Kentucky for several years. Last year, 233 people died with heroin in their systems, according to the state medical examiner's office. Last month Kentucky approved emergency regulations to allow pharmacists to provide Narcan without a prescription.