The Food and Drug Administration has fast-tracked a nasal spray application of naloxone, a highly effective medicine that helps save the lives of addicts in the midst of a heroin overdose. Faced with an alarming rise in the abuse of opiates such as heroin and prescription painkillers, the FDA moved to accelerate the approval process of the intranasal version of the lifesaving drug. Clinical trials of the spray are near completion. The new product dispenses a single dose of naloxone via the nostril, a less intrusive delivery system than the injectable form of the drug presently used to restore breathing in overdose victims. The small plastic nasal device is the brainchild of University of Kentucky College of Pharmacy professor Daniel Wermeling. Kentucky ranks sixth in the nation for painkiller overdose deaths. “Opioid addiction is not just something you think of with poor people or inner-city,” Wermeling said in a YouTube interview posted Aug. 5 by the University of Kentucky. “It cuts across a wide swath of all socioeconomic places.” The goal is to make the intranasal version of naloxone available to patients at high risk of opioid overdose as well as to caregivers who may lack medical training, Wermeling told Science Daily. “The treatment could be given in anticipation of EMS arrival, advancing the continuum of care and ultimately saving lives,” he said. The FDA’s fast-track program is intended to speed the development and review of drugs that show the potential to treat serious or life-threatening conditions and address an unmet medical need. Its accelerated review of the nasal product comes on the heels of a four-month, fast-track review of a hand-held naloxone auto-injector, also for use by non-medical personnel, to reinstate breathing in an addict who has overdosed. The injectable device, called Evzio, can be carried in a pocket or kept in a medicine cabinet. It was given the FDA’s blessing in April. Getting naloxone into the hands of caregivers, whether in the form of a nasal spray or an easy-to-use injector, marks a turning point in how the country addresses heroin and prescription opioid addiction. “This is a very big step in the de-stigmatization of addictions because it puts saving the life of the addict above other considerations,” said Dr. David Sack, an addiction specialist and CEO for Promises Behavioral Health. The opioid reversal medicines are not a form of treatment, “but will allow users to live to fight another day,” Dr. Sack said. The National Institutes of Health, via the National Institute on Drug Abuse, funded $3 million of Wermeling’s product development studies; the Kentucky Science and Technology Corporation also contributed. Users of opiates including heroin can quickly find they’ve entered the state of addiction, a medical condition that requires sustained treatment as do other medical conditions, be they diabetes or asthma. Substance abuse disorder is complex and addiction experts say it takes an average of six to seven quit attempts to realize sobriety – and then there’s the work of maintaining it. Addicts who do get clean but later go back to heroin, for instance, face an increased risk of fatality; they may return to the dose they were abusing at the height of their addiction, but their bodies have a much lower tolerance. Enter naloxone. It has been on the market for some years but until very recently was available only to medical personnel and first-responders. The approval earlier this year to put the auto-injector into the hands of an addict’s family members and friends was a major pivot point in the growing effort to deal with increased opiate addiction.
How Timely is the Approval?
Opiate abuse is at epidemic levels in this country. The National Survey on Drug Use and Health has reported that the number of people who say they have used heroin in the last 12 months has nearly doubled since 2007 to 620,000. According to the Justice Department, about 110 Americans die every day from drug overdose, and more than half of those deaths involve opiates. Earlier this year, Atty. Gen. Eric Holder called opiate abuse and overdoses a public health “crisis.” Heroin is an opiate, and opiates are found in several painkillers. OxyContin is among those prescription pain pills, and contains essentially a synthetic form of heroin. The pills are $20 to $60 a piece, and as the body’s hunger for the drug increases, addicts often turn to heroin as a substitute at just $3 to $10 a bag. More than 77 percent of participants in a 2008-2010 study reported using prescription opioids non-medically before moving on to heroin, as compared to 66.8 percent in the 2002-2004 study. Regarding a newly reported research study of young adult prescription opiate users in New York, “Our results reveal that PO (prescription opioid) misuse can lead to long-term opioid dependence, as well as transition to heroin use and drug injection,” a co-investigator on the study, Dr. Honoria Guarino, told Science Daily. “In New York City, as in many locations in the U.S., heroin is cheaper and more readily available than POs, especially as new government restrictions on PO access are implemented.” At the University of Kentucky, professor Wermling said that his intranasal device has been a dream come true. “In the end,” he told Science Daily, “it’s all about people.”