Americans May Finally Get Access to OTC Naloxone

By Jeffrey Singer — Dec 15, 2022
It appears to defy logic that naloxone, the antidote for opioid overdoses, isn't available on demand. After all, it's a lifesaving drug with no potential for abuse. But it's not so simple, as Dr. Jeffrey Singer explains.
Image: CDC

I have written for years that the Food and Drug Administration should make the opioid overdose antidote naloxone over‐​the‐​counter. Public health attorney Corey Davis spoke of how urgent it is for the FDA to move quickly to reclassify this safe and effective harm reduction tool and a Cato Institute conference in 2019.

Even though, as I and others have pointed out, the FDA Commissioner can unilaterally reclassify the prescription‐​only drug as over the counter, the FDA has been deferential to the naloxone manufacturers, who have been reticent to submit applications. Over the past several years the agency has tried to nudge the manufacturers to apply for reclassification, even going to the trouble of developing the Drug Facts Label (DFL) the FDA requires manufacturers to place on OTC products. Then‐​FDA Commissioner Scott Gottlieb called this move “unprecedented.”

And last month the FDA issued a notice in the Federal Register that “a preliminary assessment that certain naloxone drug products–up to 4 milligrams (mg) nasal spray and up to 2 mg autoinjector for intramuscular (IM) or subcutaneous (SC) use–may be approvable as safe and effective for nonprescription use.”

It appears the FDA’s nudging might be finally having an effect. The Wall Street Journal reported yesterday that Emergent BioSolutions, Inc., makers of the popularly used Narcan brand naloxone nasal spray applied to the FDA to have the product reclassified to OTC. The FDA announced plans to fast‐​track the approval process and the drug might be available over the counter as soon as March, 2023.

Perhaps Emergent BioSolutions was further nudged by the announcement, last week, that a new start‐​up company planned to produce a naloxone nasal swab and seek over the counter approval from the FDA. A randomized trial of the product suggests it might even work to reverse opioid overdoses faster than the nasal spray. And Harm Reduction Products, Inc. a non‐​profit partially funded with settlement funds from government lawsuits brought against now bankrupt Purdue Pharma, the makers of OxyContin, also announced plans to develop an OTC naloxone product.

Soon competition in the OTC naloxone market will drive prices down while increasing access to the valuable harm reduction tool. It is upsetting to think of the overdose deaths that could have been averted while Americans waited to get to this point, but they soon may have ready access to naloxone off the shelf in pharmacies, supermarkets, convenience stores, and even vending machines.