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Daniel Wermeling, University of Kentucky pharmacy professor and founder of AntiOp, Inc.
In a state on the front lines of a nationwide battle against increasing heroin overdose deaths, one University of Kentucky pharmacy professor’s innovation has the potential to save lives.
Daniel Wermeling developed a nasal spray version of the anti-overdose drug naloxone hydrochloride, the first of its kind submitted for approval to the Food and Drug Administration. The product is on a fast track for expedited review of drugs that treat serious conditions.
“This is just like an EpiPen, conceptually,” Wermeling said. “The goal is to save time.”
In May, Indivior PLC, a pharmaceutical company specializing in drugs for addiction treatment, purchased the product.
An expert in intranasal drug delivery, Wermeling founded his company, AntiOp Inc., in 2009 after he recognized an unmet medical need for a needle-free delivery method of naloxone. The drug has been approved since 1971 for delivery by injection, but paramedics and emergency departments commonly administer it off - label using a mucosal atomization device that turns an injectable drug into a nasal spray. The problem, said Wermeling, is that the injectable formulation is about 10 times too dilute to be fully effective when administered via nasal spray.
“You have to start at the end and work backwards. What do people need? A single-dose, needle-free, inexpensive, durable product that you can use anywhere,” Wermeling said.
The new product pairs a reformulation of naloxone and an already-approved plastic nasal spray device, thus reducing regulatory and development hurdles.
Wermeling said that the biggest barrier in the development process was the business model, since nasal delivery of naloxone wasn’t a new idea and the market for the drug, commonly referred to by the brand name Narcan, was relatively small, despite growing need.
His company leveraged federal and state funds in combination with UK’s research infrastructure to develop the product quickly, effi ciently and cheaply. In 2010 he was awarded $1.45 million from the National Institutes of Health’s Small Business Technology Transfer (STTR) program, which supports cooperative research and development between small businesses and research institutions. He then received $150,000 from Kentucky’s competitive STTR matching program, funded by the Kentucky Cabinet for Economic Development. The matching funding was critical for many aspects of business development, such as legal costs, not covered by NIH grants.
“The feds pay for science, not business,” Wermeling said.
Following a successful first phase of research, Wermeling was awarded a three-year, $3 million grant from the National Institute of Drug Abuse to continue research and development of the naloxone nasal spray. He also received $500,000 of Phase 2 funding from Kentucky’s STTR matching program.
“To get done what we needed to get done for $5 million or $6 million and then turn it over has to be one of the most inexpensive drug development projects in history,” he said.
Wermeling expects that total development costs won’t exceed $15 million, including the work that Indivior will undertake to get the drug approved and on the market.
Since selling the product, Wermeling’s company has repaid the full $650,000 of Kentucky matching funds, which is required by the program if a company or product is sold to an out-of-state buyer. He said UK already received $400,000 in payment and will receive further milestone payments as development and marketing continues.
Wermeling sees the increased availability of naloxone as a crucial frontline defense against overdoses from both prescription opioids and heroin. According to research by the Kentucky Injury Prevention and Research Center, 1,019 Kentucky residents died from overdoses in 2013. This was the second-highest drug overdose death rate in the country at 23.7 deaths per 100,000 people, compared with 13.8 nationally. While the majority of these overdose deaths involved pharmaceutical opioids, Kentucky experienced a 50 percent increase in heroin overdoses from 2012 to 2013. Similarly, the national rate of heroin overdose deaths rose by 42 percent over the same period.
“The deaths are a public health disaster for our state,” said Wermeling.
He acknowledges the growing heroin problem but also emphasizes that licitly prescribed drugs pose a continued and serious risk to patients and those around them, such as toddlers who might accidentally ingest them or household members who might use them recreationally.
“Many cases of overdose are therapeutic misadventures,” said Wermeling.
In addition to research and development of the nasal spray, Wermeling has also been actively involved in advocacy and policy related to naloxone. He praised the legislation passed in May that allows pharmacists in Kentucky to prescribe naloxone to at-risk individuals and their family members or friends. Wermeling not only provided expert testimony to the legislature but also worked with the Kentucky Board of Pharmacy and UK College of Pharmacy to develop the protocol and licensing for pharmacists to prescribe naloxone.
He dismisses concerns that increased availability of the anti-overdose nasal spray will lead to increased drug usage.
“Nobody takes more drugs because of [naloxone] being around. There have already been studies. It’s a nonissue,” he said.
While the use of the naloxone has evolved in recent years, Wermeling points out that there’s not yet a standard of care. He hopes that it will include co-prescribing naloxone to patients receiving opioids, but acknowledges that increasing access for harder to reach populations, such as individuals with heroin addiction or individuals experiencing homelessness, will be challenging.
“As pharmacists, part of our oath is to relieve human suffering. And this is suffering. Big time,” he said.