A University of Kentucky pharmacy professor has developed a nasal spray to stop heroin and other opioid overdoses, and his invention has now been fast-tracked by the Food and Drug Administration.
Daniel Wermeling, who also is a UK alumnus, has worked on ways to better administer naloxone, a drug that can reverse potentially fatal overdoses. The drug is used with a needle by emergency workers and others, but nasal spray is a quicker and easier method.
The project is in its final round of clinical trials and could be available as early as next year. Wermeling has worked on it directly since 2009, and most recently, he was supported by a three-year, $3 million grant from the National Institutes of Health, with additional funding from the Kentucky Science and Technology Corp.
Wermeling said he hopes his device becomes as accessible as Epipens, which are used to deliver antihistamines in cases of severe allergy attacks.
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"You can fill a prescription at one of our pharmacies and have this in your home if you have an at-risk family member," Wermeling said Thursday. But, he said, "there is a huge education gap for medical professionals."
Earlier this year, the General Assembly failed to pass a law allowing third parties to get prescriptions to naloxone. Wermeling testified in support of the bill.
"The goal is to make the medication available to patients at high risk of opioid overdose and to caregivers, including family members, who may lack specialized medical training," he said.
He has worked for many years in drug development, but he said he was spurred to further work on naloxone after two Morehead State University students overdosed on opioids in 2009. Wermeling is a native of Edgewood in Northern Kentucky, a region that has become ground zero in overdose deaths in the state.
Kentucky has the third-highest drug overdose mortality rate in the United States, with 23.6 overdose deaths per 100,000 people, according to a 2013 report by the Trust for America's Health.
The report found that the number of drug-overdose deaths in Kentucky — a majority of which are from prescription drugs — quadrupled since 1999.
At a news conference Thursday, Wermeling pointed out that stricter rules on prescription drugs means more addicts are turning to heroin, which in turn will fuel higher rates of HIV/AIDS and hepatitis C, which can be spread by dirty needles.
In 2013, Lexington EMTs administered 843 naloxone shots, mostly for heroin overdoses, according to Lexington fire officials. Coroner Gary Ginn reported that Fayette County had 44 heroin-related deaths in 2013.
Wermeling said his work would not have happened without the researchers before him, including former UK professor Anwar Hussein, who had started work on nasal drug deliveries.
"This is a project with a longer legacy than these grants," Wermeling said.
UK Pharmacy Dean Tim Tracy said Wermeling's work illustrated "bench to bedside" research.
"Dr. Wermeling and his colleagues saw a problem facing families in Kentucky and across the nation and developed an innovative solution," Tracy said. "That type of translational approach is important to our college, this university and, of course, the future of our commonwealth."
UK and Wermeling won't make millions off the new device, because naloxone has been around for many years. Wermeling has started a company, AntiOp, and has partnered with Reckitt Benckiser Pharmaceuticals to accelerate production and marketing of internasal naloxone.
"This will not have a lot of economic benefit," Tracy said, "but it's doing the right thing."