Opioid Overdose Treatment Might Soon Be Available Over the Counter
An FDA panel recommended the lifesaving nasal spray be distributed without a prescription
A nasal spray drug to reverse opioid overdoses might soon be available over the counter. On Wednesday, an expert advisory panel to the Food and Drug Administration (FDA) voted unanimously to recommend that this form of the drug naloxone should be accessible without a prescription.
The FDA is expected to make a decision on the lifesaving treatment, sold under the brand name Narcan, by March 29. The FDA almost always follows its scientific advisors’ recommendations, per Stat News’ Lev Facher.
“For the sake of the public and saving lives, I believe this medication should be available over the counter as soon as possible,” Katalin Roth, a professor of medicine at George Washington University, said after the vote, according to NBC News’ Berkeley Lovelace Jr.
Drug overdose deaths in the United States have increased fivefold over the last two decades, according to the Centers for Disease Control and Prevention (CDC). In 2021, nearly 107,000 people died from an overdose. Of those, an estimated 80,000 deaths involved opioids, a class of drugs that includes fentanyl, heroin and prescription medications such as oxycodone and morphine. The number of opioid prescriptions for treating pain started to grow in the 1990s, leading to an increase in overdoses and deaths.
Public health and medical experts consider naloxone to be the only available tool for reversing an opioid overdose, writes Stat News. The treatment rapidly attaches to opioid receptors in the nervous system, reversing and blocking the effects of other opioids.
Most states already allow people to get naloxone without a prescription, according to Axios’ Sabrina Moreno. But in practice, the drug must be kept behind the counter, not every pharmacy carries it and asking for the drug carries a stigma, writes Matthew Perrone of the Associated Press (AP).
“If naloxone becomes a nonprescription product, it may be sold in many venues previously unavailable to consumers, including vending machines, convenience stores, supermarkets and big-box stores, just like other nonprescription products,” Jody Green, an official at the FDA’s nonprescription drug division, told the expert panel Wednesday, according to CNBC’s Spencer Kimball.
“It’s going to make a tremendous impact on how people view the medication,” Sheila Vakharia, deputy director of research and academic engagement at the Drug Policy Alliance, tells the AP. “It will help to destigmatize it and make people know it’s safe and easy to use.”
Last fall, the FDA asked drugmakers to apply for nonprescription use of their naloxone products, per Axios. Emergent BioSolutions, manufacturer of Narcan, applied to the FDA late last year. Narcan is the most commonly sold treatment for opioid overdoses, per CNBC.
The company has not said how much the drug would cost over the counter, but officials hope that making it more widely available will increase sales and lower costs. A two-pack of 4-milligram nasal spray typically costs between $35 and $65, per Stat News.
Most panel members agreed the nasal spray was safe to administer without medical supervision. But their concerns centered around whether people would understand the drug’s instruction label. The experts gave suggestions for making the directions easier to follow, including fitting them on a single panel and adding pictograms.
The panel also critiqued a study in which Emergent Biosolutions tested the user-friendliness of the labeling and instructions. They called out leading language, a low number of participants with limited literacy and a lack of testing whether children could understand the label.
But since the drug is urgently needed, the panelists said the labeling changes should not hold up its release, per the New York Times’ Jan Hoffman.
If the treatment is accidentally given to someone without opioids in their system, the drug doesn’t have any effect, according to the National Institute on Drug Abuse.