By Lauren Smith

Updated: 22 May 2023

The opioid antidote naloxone could be available without a prescription as early as this summer, as two advisory panels recommend the FDA lift restrictions on the drug in order to stem the tide of opioid overdoses.

Naloxone Could Become Widely Available Over-The-Counter

FDA advisory committees recommend approval of naloxone without a prescription

The unanimous vote by the committees increases the likelihood that the Food and Drug Administration (FDA) will approve a generic, over-the-counter version of naloxone nasal spray, following two fast-tracked applications from pharmaceutical company Emergent BioSolutions Inc. and non-profit and Harm Reduction Therapeutics. The regulator could approve the products as early as this month.

Naloxone, popularly known by the brand name Narcan, is an opioid antagonist that blocks the effects of opioids on the brain and can rapidly reverse overdose symptoms, including respiratory depression and extreme sedation. It was initially approved as an injection by the FDA in 1971, intended for use by first responders and hospitals to revive people experiencing overdoses. 

But with the rise in opioid abuse and overdose over the last two decades, naloxone has been used more and more frequently by people without full medical training, including outreach workers, the family and friends of opioid users, and good samaritans. Administered millions of times over the last few years, it’s estimated to have saved hundreds of thousands of lives.[1]

Easy-to-administer versions of naloxone such as nasal sprays have been developed to facilitate its use and the drug is distributed through community-based naloxone programs and syringe service programs.[2] Many states also permit pharmacies to supply the drug under standing orders, or non-patient-specific prescriptions.[1] However, obtaining the drug under standing orders so requires the customer to interact directly with the pharmacist, which may deter some drug users, and limits sales to pharmacies, which are often scarce in rural areas.

Sell Narcan widely and without stigma to reduce deaths, advocates say 

Doctors, harm reduction groups, and the Biden administration have all urged the FDA to scrap the prescription requirement entirely and enable naloxone to be sold at supermarkets and convenience stores.

They argue that wider availability of naloxone could reduce deaths from opioids—particularly the potent fentanyl—which climbed to over 106,000 in 2021.[3]

And it’s not just about availability. Harm reduction groups argue that selling naloxone on the shelves beside Tylenol and condoms would normalize its use.

“It also sends a message—we’re trying to remove the stigma around the drug,” Laura Palombi, professor of pharmacy and public health at the University of Minnesota, told the Washington Post.[4]

Panels concluded that the drug is safe and easy for non-medical people to use

The two advisory panels—the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee—concluded that naloxone is broadly safe, with side effects limited to those associated with opioid withdrawal and far outweighed by the life-saving effects of the drug. 

Naloxone is also safe when mistakenly administered to someone not experiencing an opioid overdose. For example, it has no effect, positive or negative, when administered to someone experiencing a heart attack or hypoglycemic shock.[5]

The committees also considered whether the drugs could be safely and effectively administered by people without medical training and carefully considered the instructions included in the package. 

Despite some concerns about Emergent’s proposed packaging for the product—which must be approved by the FDA—the experts concluded that the urgency of addressing the opioid crisis eclipses the need to run further tests of user-friendliness.

Cost is still a barrier

However, some harm reduction groups warn that the impact of over-the-counter naloxone will be limited unless the price comes down. Currently, the discounted price for a two-pack of Narcan nasal sprays at pharmacies is $47, but the Washington Post found some pharmacies in the D.C. area retailing the prescription version for as much as $73.

“No drug user is going into a pharmacy and paying $47 a kit,” Colin Miller, co-founder of the Twin City Harm Reduction Collective in North Carolina, told the newspaper.[4]

Emergent hasn’t revealed its intended pricing for its over-the-counter naloxone product. The company says it will continue to sell discounted packs to “public interest” customers, including harm reduction groups.