FDA Approves Overdose-Reversing Narcan for Over-the-Counter Use

4 min read

March 29, 2023 – The FDA has approved the opioid overdose-reversal drug Narcan for over-the-counter use, the agency announced Wednesday morning. 

The nasal spray uses the drug naloxone hydrochloride and will be available to purchase online, as well as at places like drugstores, grocery stores, and gas stations. It became available by prescription in 2016.

Opioid overdoses kill more than 100,000 people in the U.S. each year, with synthetic opioids like fentanyl accounting for most of those deaths. FDA Commissioner Robert M. Califf, MD, said making Narcan easier to get will address a “dire public health need.”

But it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves. Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.

“The major question is what is it going to cost,” said Brian Hurley, MD, president-elect of the American Society of Addiction Medicine. “In order for people to access it they have to be able to afford it." 

“We won’t accomplish much if people can’t afford to buy Narcan,” said National Council for Mental Wellbeing President and CEO Chuck Ingoglia in a statement. But, he noted, "no single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually." 

“[The] FDA’s decision will transform how we compassionately and logically respond to the overdose epidemic,” said Bobby Mukkamala, MD, chair of the American Medical Association’s Substance Use and Pain Care Task Force, in a statement. “More lives will be saved when naloxone is easily available at grocery stores and pharmacies,” and it “will help destigmatize obtaining and using naloxone,” he said. 

But "for this change to be most impactful, manufacturers must make the price of naloxone affordable, a crucial element for community organizations that are working to make it available," he said. 

In a statement, the FDA said the cost of the drug as well as the timeline for its availability "is determined by the manufacturer." 

“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," Califf said. 

Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on U.S. shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.

Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31 to $100, depending on location and coupon availability. A two-dose box of Narcan costs $135 to $140. Emergent reported a 14% decline in naloxone sales in 2022 -- to $373.7 million -- blaming it in part on the introduction of generic formulations. 

Hurley said he expects the people who purchase Narcan at a drugstore will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness, he said.

Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” said Hurley.

The FDA has encouraged naloxone manufacturers to seek OTC approval for since at least 2019, when it designed a model label for a theoretical OTC product. In November, the agency said it had determined that some naloxone products had the potential to be safe and effective for over-the-counter use and again urged drugmakers to seek such an approval. 

Emergent BioSolutions was the first to pursue OTC approval, but another manufacturer, the nonprofit Harm Reduction Therapeutics, is awaiting approval of its application to sell its spray directly to consumers. In December, Harm Reduction Therapeutics said its application for a nasal spray was being fast-tracked by the FDA, and if approved, the product would be sold at cost for $18.

Mukkamala said that the AMA is urging every manufacturer to seek OTC approval and called on manufacturers to work with retailers to make the products prominent on store shelves. Health insurers “must continue or start to cover naloxone at no- or low-cost,” said the AMA.

Scott Gottlieb, MD, who was the FDA Commissioner from 2017 to 2019, said in a tweet that more work needed to be done. 

“This regulatory move should be followed by a strong push by elected officials to support wider deployment of Narcan, getting more doses into the hands of at-risk households and front line workers,” he tweeted.

Making Narcan easier to get will make it more likely to have on hand during an emergency. The drug can restore breathing that has slowed or stopped in someone who has overdosed on opioids. The published instructions for using Narcan say to use the drug after first identifying an opioid overdose by taking the following steps:

  • Ask the person if they are OK and shout the person’s name. Shake the person’s shoulders and firmly rub the middle of their chest. 
  • Check for signs of an opioid overdose, such as the person will not wake up or respond to your touch or voice; breathing is very slow, irregular, or has stopped; and their pupils look like pinpoints.