FDA advisers vote in favor of making opioid overdose antidote available over the counter

By Jen Christensen, CNN

If the US Food and Drug Administration gives the go-ahead, a nasal spray version of the opioid overdose antidote Narcan may soon be sold in vending machines, big box stores, grocery stores and gas stations across the country.

Two FDA advisory committees met Wednesday and voted unanimously in favor of making the spray available over-the-counter so more people could have access.

The final decision is left up to FDA Commissioner Dr. Robert Califf, who has sole discretion on actions taken with regard to drug approval.

A decision to make the antidote available without a prescription would be “precedent-setting,” the agency said.

Narcan is available in many pharmacies with or without a prescription, but it’s kept behind the counter. Research shows that wider availability could save lives as US opioid overdose numbers skyrocket.

At Wednesday’s meeting, the FDA said it hoped to expedite a nonprescription version of naloxone, the generic name for Narcan. It has advised the industry to change the label to add simple directions for use and possibly instructions to call 911 after administering the drug.

The Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee discussed several ways the instructions could be made easier for everyone to understand, even children or non-English readers.

Committee member Dr. Brian Bateman said that although there is room for improvement on the drug label and additional studies might be conducted, “perfect shouldn’t be the enemy of good.”

“This is a very important step from the cultural perspective. A key component of our addressing the ongoing opioid crisis will be broadening community access to this medication and decreasing the stigma associated with the purchase of naloxone. We know from long experience that this is a safe and effective medication,” said Bateman, a professor and chair of the Department of Anesthesiology, Perioperative and Pain Medicine at the Stanford University School of Medicine.

The nasal spray would come in a package of two 4-milligram doses, in case the person overdosing did not respond to the first dose. However, the drug’s maker says most overdoses can be reversed with a single dose. The product could be given to anyone, even children and babies.

Narcan works by blocking the effects of opiates on the brain and restoring breathing. For the most effectiveness, the person who’s overdosing must get the antidote right away.

The drug works on someone only if there are opioids in their system. It can’t prevent an overdose and won’t work on any other type of drug overdose. But it won’t have adverse effects if given to someone who hasn’t taken opioids.

Naloxone reverses an overdose for up to about 90 minutes, but opioids can stay in the system for longer, so it’s still important to call 911 after giving the drug.

People given naloxone should be watched carefully until help arrives and monitored for another two hours.

It’s kind of like a fire extinguisher, one expert told the FDA committees.

“It’s the thing that you want to have in your home for safety, and you hope never to have to use it. But you want to have access to one so that when you need it, it’s right there,” said Dr. Scott Hadland, chief of adolescent and young adult medicine at MassGeneral Hospital for Children.

Hadland said opioids have become a much bigger problem for his pediatric patients.

“I’ve lost patients over the years and have watched as many families have been devastated by this rising, worsening and skyrocketing overdose crisis,” Hadland said.

Research shows that most teen overdoses happen at home, and in two-thirds of cases, someone there could have given an antidote. But national data shows that naloxone is given in fewer than 1 in 3 teen overdose deaths, he said.

“There is a huge gap here where there is an enormous need for opioid overdose reversal, and yet naloxone is not getting to the places that it needs to be,” Hadland said. “In my expert opinion, ready availability of naloxone in US households could avert numerous, if not many, overdose deaths that are currently occurring on a daily basis right now.”

More than a million people have died of drug overdoses in the two decades since the US Centers for Disease Control and Prevention began collecting that data. Many of those deaths were due to opioids. Deaths from opioid overdose rose more than 17% in just one year, from about 69,000 in 2020 to about 81,020 in 2021, the CDC found.

Opioid deaths are the leading cause of accidental death in the US. Most of the deaths are among adults, but children are also dying, largely after taking synthetic opioids like fentanyl. Between 1999 and 2016, nearly 9,000 children and adolescents died of opioid poisoning, with the highest annual rates among adolescents 15 to 19, the CDC found.

Dr. Jody Green, the FDA’s deputy division director for safety for the Division of Nonprescription Drugs, said that opiate overdoses are often witnessed by a family member or friend who has no medical background.

“That is why it is imperative to develop a naloxone product that can be used without training,” she said.

As a prescription drug, the safety and efficacy of Narcan nasal spray is well-established, Green said.

She said the FDA wants to make sure that the design of the user interface, including labeling, would be clear enough that people of all ages could use the drug effectively without the help of an EMT or other health care provider. Much of Wednesday’s discussion centered on how to make the instructions easy to understand.

During the meeting’s public discussion, a representative from the American Medical Association spoke in favor of making Narcan easy to access.

The association said it has supported state laws that increase access.

“Barriers to naloxone, however, limit these efforts, including the fact that naloxone is currently tucked behind the pharmacy counter,” said Dr. Bobby Mukkamala, immediate past chair of the AMA board. “Removing the prescription status of naloxone and making it available over the counter will send a powerful message that naloxone is a critical public health tool for everyone.”

The group urges insurance companies to cover the nonprescription version.

“We believe that removing the prescription status of naloxone will allow for many emergency departments, health clinics, colleges, universities, high school and physicians offices to better distribute naloxone,” Mukkamala said.

Drugmaker Emergent said it was pleased with Wednesday’s vote.

“This favorable recommendation marks another important step forward to broaden access to Narcan Nasal Spray for those who may be at risk of an opioid overdose,” Paul Williams, SVP and Products Business Head, wrote in an email to CNN. “Today’s vote reaffirms our confidence in the safe and effective use of Narcan in the community setting.”

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