A new lifesaving product to treat painkiller overdoses is in its final round of clinical trials at the University of Kentucky and is being fast-tracked by the U.S. Food and Drug Administration.
The product is a nasal-spray application of the anti-opoid drug naloxone, developed by Daniel Wermeling, professor in the UK College of Pharmacy, through his startup company AntiOp Inc.
Opioids are the class of pain-killing drugs that are related to morphine, including prescription drugs such as hydrocodone and oxycodone as well as illegal drugs such as heroin. Naloxone is the the standard treatment for suspected opioid overdose, according to a UK news release.
Naloxone is now administered by injection. The spray eliminates the need for needles, with a ready-to-use, single-use delivery device inserted into the nose of an overdose victim. The product delivers a consistent dose, absorbed across the nasal membranes even if the patient is not breathing.
“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,” Wermeling said. “The treatment could be given in anticipation of EMS arrival, advancing the continuum of care and ultimately saving lives.”
Nationwide, deaths from opioid overdose are on the rise, according to the federal Centers for Disease Control and Prevention. Kentucky, with a long history of opoid abuse, ranks third in the nation for drug overdoses, with more than 1,000 dying each year. Heroin abuse is on the rise, with 230 deaths, or 31.9 percent, of autopsied overdose deaths attributed to heroin in 2013. This is a 60 percent increase from the previous year, according to the Kentucky Office of Drug Control Policy.
Congratulating Wermeling on his success, UK President Eli Capilouto said, “The epidemic of opioid abuse in our state presents an enormous and urgent challenge, not only for health care providers and law enforcement but also for us here at the University of Kentucky. Dr. Wermeling’s project is putting a powerful new tool into the hands of those on the front line of the fight against heroin, both here in Kentucky and beyond.”
Wermeling’s research was supported by a three-year, $3 million grant from the National Institutes of Health through the National Institute on Drug Abuse with additional funding from the Kentucky Science and Technology Corporation. His company partnered with Reckitt Benckiser Pharmaceuticals in May to accelerate the production and worldwide marketing of the product.