The U.S. Food and Drug Administration announced Wednesday that it had approved a nasal-spray version of naloxone, a drug that can reverse the effects of a heroin overdose. The new version will make it easier to administer and less intimidating than the previously approved injectable form. Sold under the brand name Narcan, the drug has been widely viewed as an essential method of reducing overdose deaths that have spiked across the country in recent years.
“Combating the opioid abuse epidemic is a top priority for the FDA,” Stephen Ostroff, M.D., acting FDA commissioner, said in a press release. “We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.”
Approximately 24,000 people died from heroin and prescription opiate overdoses in 2013, accounting for well over half of all drug overdose deaths. While prescription opiates still account for more overdose deaths than heroin, the number of fatal heroin overdoses has surged over the past few years and continues to rise at a startling rate. Between 2002 and 2013, the rate of death by heroin overdose nearly quadrupled, with a massive 39 percent jump from 2012 to 2013.
Due to the pharmacological effects of opioids, which impact the part of the brain that regulates breathing, overdose deaths usually result from respiratory depression. Naloxone is an opiate antagonist, which means it essentially blocks opiates from affecting the brain and actually kicks out the opiates that are already there. When administered quickly, naloxone can counter the overdose effects, usually within two minutes, according to the FDA.
Previously, naloxone was only approved in injectable forms, such as syringes or auto-injectors. However, advocates fighting the epidemic had already seen the value of a nasal-spray model and had been using them, even without FDA approval. Tutorials for how to use the product can be found online.
In its press release, the FDA acknowledged the issue: “There has been widespread use of unapproved naloxone kits that combine an injectable formulation of naloxone with an atomizer that can deliver naloxone nasally. Now, people have access to an FDA-approved product for which the drug and its delivery device have met the FDA’s high standards for safety, efficacy and quality.”
Clinical trials showed that spraying Narcan in one nostril delivered about the same or higher levels of naloxone as a single dose of a naloxone injection. The drug can be given to adults or children, the FDA said. And unlike previously-approved injectable forms of naloxone, the nasal spray does not require assembly, which allows it to be administered more rapidly.
“This easy-to-use intranasal formulation will no doubt save many lives,” Nora Volkow, M.D., director, National Institute on Drug Abuse at the National Institutes of Health, said in the FDA press release.
However, the FDA cautioned that once the drug has been given, people should seek immediate medical treatment. The drug is not meant to replace medical care.
While making anti-overdose drugs more readily available and easier to use is an important step that will avert many deaths, there is also an urgent need to expand access to substance abuse treatment. As USA Today reported earlier this year, “Many [overdose] deaths could be prevented if patients had better access to substance abuse therapy… Yet people battling addiction say that treatment often is unavailable or unaffordable.”
According to the National Survey on Drug Use and Health, just 11 percent of the more than 23 million Americans who are addicted to alcohol or drugs get treatment, a percentage that has barely budged in more than 40 years.