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The overdose reversal drug has been administered mostly by emergency responders and outreach workers. If the agency approves a nonprescription version, it could become as easily available as aspirin.
Two federal panels of addiction experts on Wednesday unanimously recommended that Narcan, the overdose-reversing nasal spray, be made widely available without a prescription, a significant step in the effort to stem skyrocketing drug fatalities.
Making Narcan an over-the-counter drug has been urged by doctors, patient advocacy groups and the Biden administration.
The unanimous vote by the committees, which advise the Food and Drug Administration, makes it highly likely that the F.D.A. will approve an over-the-counter version, also known generically as naloxone, next month. It could potentially become available in vending machines, schools, convenience shops, big box stores and supermarkets by summer.
As the overdose crisis worsened in recent years, the use of Narcan has become commonplace, but the millions of doses have been administered largely by outreach workers, health care providers and emergency responders. For people who use drugs as well as their friends and relatives, ready access to the prescription medication has been elusive.
Many public health experts believe that if more people were to have the spray readily available at home, or in their pockets or knapsacks, many fatalities could be averted.
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The Biden administration has made expanding access to the medicine a priority in its efforts to combat the overdose crisis, which reached a record 107,000 deaths in 2021. The rising fatalities include people addicted to opioids as well as those who illegally purchased prescription medications like Xanax or Percocet that had been tainted with the deadly synthetic opioid, fentanyl. Experts at Wednesday’s daylong hearing noted that even stimulants like methamphetamine and cocaine are being mixed with fentanyl, leading to even greater numbers of accidental overdoses.
In recommending that the spray become as easily available as ibuprofen, the 19 voting panelists determined that naloxone, which was approved as an overdose-reversal injection in 1971, is abundantly safe and effective even in infants, with almost no potential for misuse or abuse. And, the panels concluded, naloxone does not require medical training to use.
Side effects, typically symptoms associated with withdrawal, were relatively negligible compared with the medicine’s far greater lifesaving benefit, panel members said. Naloxone, which comes in a nasal spray, a vial and preloaded syringes, is believed to have saved hundreds of thousands of lives.
The drug blocks the effects of opiates on the brain. Opiates can depress the respiratory system and other bodily functions. By interrupting that connection before it’s too late, Narcan can wake a person from a lethal stupor. The instructions on the two-pack carton say that the Narcan administrator should apply one dose in the nostril of a person suspected of having overdosed and then call 911. If the person does not rouse within two or three minutes, a second dose can be applied in the other nostril.
The unusual unanimity of the vote “underscores the importance of moving this drug to greater access and also highlights the terrible risk of not acting in terms of making the drug more accessible,” said Maria C. Coyle, chairwoman of the advisory panel and an associate clinical professor at the Ohio State University College of Pharmacy.
The panel said that over the years that Narcan had been deployed, a handful of severe outcomes, such as death, had not been directly connected to Narcan itself but to attendant issues, such as delayed application or other drugs involved.
The F.D.A. had encouraged companies to submit applications to be considered for over-the-counter naloxone; the manufacturer of Narcan, Emergent BioSolutions, stepped forward.
Many voting and nonvoting experts, who included emergency responders, toxicologists, pharmacists, pediatricians and addiction medicine specialists, said that improvements were needed in the proposed labeling and packaging of over-the-counter Narcan. They suggested improvements to the company’s font, color choices and pictograms, which are intended to quickly guide panicky helpers through administering the medicine.
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Such refinements were important, they said, also recommending that instructions specify the number of doses. They also said that the manufacturer had not evaluated whether young children can follow the directions and administer the medicine to siblings and parents. But the panelists emphasized that such adjustments should not be an impediment to releasing an urgently needed drug.
Still, Dr. Leslie R. Walker-Harding, a panel member who is a pediatrician at Seattle Children’s Hospital, criticized the company for not enrolling people under 15 in studies looking at whether children could readily understand how to use the drug.
“What is traumatizing to a kid is watching their loved one be unconscious, dying, and not being able to do anything about it,” she said, adding, “Children can protect us and protect themselves and are humans all on their own.”
The price of the drug and insurance coverage were not issues before the panel, but they were raised during the public comments section of the hearing. Jessica Hulsey, the executive director of the Addiction Policy Forum, said that over-the-counter availability of Narcan should not replace funding for distribution of free Narcan to people who use drugs, especially those in high-risk populations, including prisoners.
She also raised concern about how Narcan would be showcased on the shelves. “Will it be behind the counter at a pharmacy?” she asked. “In lockboxes with razors and other products?” she added, pointing out that such placements could further stigmatize Narcan and its potential customers.
Many states already permit pharmacies to stock Narcan under what is known as a “standing order.” But because of deep-seated stigma toward people who use drugs, pharmacists are often reluctant to carry supplies or to engage with consumers, who may in turn become hesitant to ask for it.
Ms. Hulsey noted that, with the probable widespread release of the spray, staff at pharmacies and supermarkets should be trained in how to treat Narcan customers respectfully, not only to help dispel stigma but to encourage purchases of the lifesaving medication.
Dr. Scott Hadland, a pediatrician and addiction specialist at Massachusetts General Hospital, who testified as an independent expert in favor of approval, said that a key aspect of making Narcan widespread would be in normalizing it. Doing so would “really battle stigma and worries that people have about intervening in these moments. This is an unprecedented time where more than 100,000 people are dying every year, and we need to change the public’s outlook and the public’s response.”