With drug overdose deaths continuing to hover near record levels, the US Food and Drug Administration on Wednesday approved for the first time an over-the-counter version of the opioid overdose antidote Narcan.
“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” FDA Commissioner Dr. Robert Califf said in a statement.
“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
Dr. Rahul Gupta, director of the White House’s Office of National Drug Control Policy, said accessibility is key to ensuring that the Narcan nasal spray saves lives.
“It’s really important that we continue to do everything possible in our power to make this life-saving drug available to anyone and everyone across the country,” Gupta said.
The White House drug czar said businesses, such as restaraunts and banks, and schools will be encouraged to purchase over-the-counter naloxone.
“We will encourage businesses, restaurants, banks, construction sites, schools, others to think about this – think about it as a smoke alarm or a defibrillator, to make it as easily accessible, because it’s not just you. It could be your neighbor, it could be your family, your friend, a person at work or school who might need it, ” Gupta said.
The nasal spray will come in a package of two 4-milligram doses, in case the person overdosing does not respond to the first dose. However, the drug’s maker, Emergent BioSolutions, says most overdoses can be reversed with a single dose. The product could be given to anyone, even children and babies.
The nasal spray is expected to be available for purchase in stores and online by late summer, Emergent said Wednesday.
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 overdoses 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 are among adults, but children are also dying, largely after ingesting synthetic opioids such as 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.
Nearly every state in the US has standing orders that allow pharmacists or other qualified organizations to provide the medication without a personal prescription to people who are at risk of an overdose or are helping someone at risk, but making it available over the counter can make it easier for people to access the opioid antidote.
Research shows that wider availability could save lives as opioid overdoses have skyrocketed in recent years – much of it due to synthetic opioids like illicitly made fentanyl.
Emergent President and CEO Robert Kramer hailed the FDA’s decision as a “historic milestone.”
“We are dedicated to improving public health and assisting those working hard to end the opioid crisis – so now with leaders across government, retail and advocacy groups, we must work together to continue increasing access and availability, as well as educate the public on the risks of opioid overdoses and the value of being prepared with Narcan Nasal Spray to help save a life,” Kramer said in a statement.
Narcan works by blocking the effects of opioids on the brain and restoring breathing. For the most effectiveness, it must be given as soon as signs of overdose appear.
The drug works on someone only if there are opioids in their system. It 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 medical help arrives and monitored for another two hours.
About 1.2 million doses of naloxone were dispensed by retail pharmacies in 2021, according to data published by the American Medical Association – nearly nine times more than were dispensed five years earlier.
Emergent said it does not have information on how much OTC Narcan will cost.
Harm reduction experts say the price of naloxone has inhibited its accessibility to people who need it most. And although the cost will probably drop as it becomes available over the counter, they say it will probably still be out of reach for many.
“We’re not going to be able to ramp up naloxone distribution in a game-changing way until we get a better handle on the price,” said Nabarun Dasgupta, a scientist at the University of North Carolina’s Injury Prevention Research Center who studies drugs and infectious diseases. “There’s the promise on paper versus on the street, and it’s going to come down to the dollars and cents.”
Separate changes to grant funding by both the CDC and the Substance Abuse and Mental Health Services Administration will make it easier for states and local health departments to buy naloxone, he said.
Gupta said the Biden administration is asking the drugmakers to keep the price of the antidote low.
“That’s one of the things that the president has been very clear: that we’ve got to make sure that these life-saving medications, as well as treatment, is accessible across no matter where you live, rural or urban, rich or poor. We want to make sure this is accessible across broad swaths of people,” he said.
However, experts said the most meaningful work in the fight against the devastating outcomes of the drug overdose epidemic will come with ongoing emphasis on treatment for opioid use disorder and other harm-reduction strategies.
“While enabling people to access quality treatment for substance use disorders is critical, we must also acknowledge that people need to survive in order to have that choice,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse, said in January.
Caleb Banta-Green, principal research scientist at the University of Washington’s Addictions, Drug & Alcohol Institute, has described naloxone as the “gateway drug” to a conversation about what substance use disorder is.
“It’s a conversation starter. It’s life-saving for the individual. It’s not a game-changer at the population level,” he said. “We need to do more. And we need to use treatment medications – methadone and buprenorphine – which are far higher overdose preventive approaches.”