FDA Approves Over-the-Counter Narcan Sales in Major Move To Curb Overdoses

In a key development in the fight against the opioid epidemic, the U.S. Food and Drug Administration announced March 29 that Narcan has been approved for over-the-counter sales across the country.

The decision, which could save lives, grants pharmaceutical manufacturer Emergent BioSolutions the go-ahead to sell its nasal-spray version of the drug naloxone on store shelves, so people who may need it can simply pick it up and pay at the register. The move eliminates barriers to accessing the overdose-reversing medication, which previously required either a doctor’s prescription or consultation with a pharmacist.

Now Narcan can legally be offered for purchase in pharmacies, grocery stores, convenience stores, vending machines, online retailers and beyond, broadening community access to naloxone. “The FDA remains committed to addressing the evolving complexities of the overdose crisis,” said FDA Commissioner Robert M. Califf, M.D., 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.”

The FDA’s step comes at a critical time. In 2021, drug overdose deaths surpassed 106,000, a single-year record, with more than 80,000 of those involving opioids, according to the Centers for Disease Control. The dramatic increase in annual deaths beginning in 2019 has been attributed in part to the spread of the potent synthetic opioid fentanyl.

In recent years, naloxone has emerged as a highly effective harm reduction tool. It can quickly and safely reverse an opioid overdose if administered in time. The drug is an opioid receptor antagonist, meaning it rapidly binds to opioid receptors in the brain, blocking the uptake of the opioid and reducing or reversing its effects. Naloxone does not cause dependence and is safe and easy enough to use that nonprofessionals can administer it with little or no training. Friends and family members of people who use opioids can keep it on hand in case of an emergency.

The opioid-blocking properties of naloxone are short-lasting, about 30 minutes; further medical care is recommended to ensure an overdose does not resume and any opioid withdrawal symptoms are managed. But those 30 minutes can mean the difference between a scary overdose and a fatal one.

Because naloxone saves lives in emergency situations with little downside, it has become a rare success story in the grim picture of the opioid epidemic. Other harm reduction tools, like fentanyl test strips and safe injection sites, have encountered obstacles to legalization and implementation.

By 2023, naloxone was already technically available in all 50 states without a prescription, but it was still classified as a prescription medication by the federal government until Wednesday, causing confusion for both individuals and pharmacies. Even without a prescription, people seeking naloxone needed to speak to a pharmacist first. Many at-risk individuals are reluctant to do so, in part because of the stigma surrounding drug use, according to recent research from the University of Texas at Austin College of Pharmacy. Many pharmacies have also failed to stock the medication, and some pharmacists have even voiced personal reluctance to dispense it.

But given the urgency of the opioid crisis, in Nov. 2022, the FDA invited drug manufacturers to submit applications for nonprescription naloxone formulations, signaling it would likely fast-track a successful application. Emergent submitted one for Narcan in a single 4-milligram dose package, and on Feb. 15, a panel of advisers to the FDA voted unanimously in support of the agency approving OTC Narcan.

Despite Wednesday’s breakthrough, there are still issues to be sorted out regarding the accessibility of Narcan, especially regarding its price. But for the first time ever, a lifesaving overdose reversal medication will be available for purchase as readily and easily as sore throat lozenges and antacid tablets.