Federal regulators have approved the first over-the-counter naloxone product, enabling people to buy the opioid overdose treatment directly from places like pharmacies, convenience stores and online.
The U.S. Food and Drug Administration announced Wednesday it approved the nasal spray naloxone product, commonly known as Narcan, for use without a prescription. Narcan has been approved as a prescription drug since 2015 and is the standard treatment to reverse an opioid overdose by reversing or blocking an opioid’s effects on the brain.
More than 101,000 fatal overdoses were reported nationwide between November 2021 and October 2022, driven mostly by opioids like fentanyl.
“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” said Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research. “The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status.”
“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis.”Dr. Patrizia Cavazzoni, Center for Drug Evaluation and Research
A timeline for when Narcan could be available without a prescription and how much it will cost are still to be determined by the manufacturer that received Wednesday’s authorization, the biopharmaceutical company Emergent BioSolutions Inc.
However, according to the FDA, the regulatory process to change naloxone from being solely available as a prescription drug to being available both with and without a prescription could take months and will require a change in labeling for currently approved 4 milligram naloxone nasal sprays.
Other Narcan manufacturers beyond Emergent BioSolutions will also be required to update their existing authorizations to make their products available as over-the-counter drugs.
“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,” FDA Commissioner Dr. Robert Califf said. “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.”