(USA Today) CINCINNATI -- A Lexington, Ky., doctor has struck a critical agreement to get a life-saving product in the hands of emergency room workers and paramedics across the country as they battle the nation's heroin epidemic.
Dr. Daniel Wermeling, a professor of pharmacy at the University of Kentucky, has signed an agreement with Reckitt Benckiser Pharmaceuticals Inc. to accelerate production and marketing of intranasal naloxone, a drug designed to treat heroin and opioid overdose. The firm's U.S operations are headquartered in Virginia.
Wermeling founded AntiOp Inc., a specialty pharmaceutical company to develop his naloxone nasal spray. The product is entering its final clinical trial in June.
"This partnership leverages our combined resources and strengths," Wermeling said.
Nationally, more than 16,500 Americans die each year from prescription opioids, which include prescription painkillers such as hydrocodone, methadone, oxycodone and oxymorphone. The drugs are chemical cousins to heroin, and the spike in their abuse has fueled the recent heroin addiction crisis.
Estimates on the number of U.S. heroin addicts range from 300,000 to 500,000, up about 75 percent from five years ago, according to the National Institute on Drug Addiction.
In the past 10 years, heroin and related opioid pain pills have killed more than 125,000 Americans, according to Centers for Disease Control and Prevention data.
Wermeling said naloxone injection is an inventory staple for thousands of emergency rooms, ambulances and post-surgery recovery rooms. Last year, St. Elizabeth Healthcare's emergency departments alone revived 545 people with Narcan, a brand name.
The drug currently is injected intravenously, into muscle tissue, or under the skin. Emergency responders have used atomizers to convert the injectable form of naloxone into a nasal spray.
Wermeling said his product improves on this idea, allowing rescue treatment when the patient is unconscious. The nasal spray will be administered using a ready-to-use, single-use delivery device that can be inserted into the nose, delivering a consistent dose absorbed across nasal membranes even if the patient is not breathing. It eliminates use of needles for injection and is disposable.
While Wermeling's product offers advantages over injection, there is still opportunity for fine tuning and design optimization, he said.
"We need to hear from end users and stakeholders about the serviceability of the product," he said. "Ultimately, we're creating intranasal naloxone to serve them, and we are striving to assist in developing the standard of care in opioid overdose cases."
The study that starts in June will measure blood levels of naloxone in users of Wermeling's intranasal product versus products on the market.
The price of the intranasal device is still unknown, he said.
Much of Wermeling's early work on the product has been funded by NIDA and the Kentucky Science and Technology Corp. He also credited UK's Colleges of Pharmacy and Medicine and the National Institutes of Health Center for Clinical and Translational Science, whose faculty and resources "were critical to our early-stage success."
Just last month, the U.S. Food and Drug Administration approved Evzio (naloxone hydrochloride injection), a new hand-held auto-injector that rapidly delivers a single dose of naloxone and can be carried in a pocket or stored in a medicine cabinet.
Under terms of the agreement, Reckitt Benckiser and AntiOp will co-develop the nasal naloxone spray throughout the FDA's regulatory approval process. Wermeling said he's confident his product will meet eligibility requirements for the FDA's fast-track review, once the application is filed.