The U.S. Food and Drug Administration has approved Narcan, a medication that rapidly reverses the effects of opioid overdose, for over-the-counter use—the first naloxone product approved for use without a prescription. The action allows the medication to be sold directly to consumers in places such as convenience stores, gas stations, grocery stores and drug stores, as well as online.
Convenience store and gas station parking lots and bathrooms have been among the common scenes of opioid overdoses, according to multiple local and national media reports in recent years.
- Read Crisis in the C-Store, the award-winning CSP magazine feature on c-stores and the opioid crisis.
Narcan is a 4-milligram naloxone hydrochloride nasal spray. It is the standard treatment for opioid overdose. The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months, it said. Other formulations and dosages of naloxone will remain available by prescription only.
Manufacturers will determine the timeline for availability and price of the OTC product. The FDA has granted the OTC approval of Narcan to Emergent BioSolutions.
Drug overdose persists as a major public health issue in the United States, the FDA said, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl.
“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” said FDA Commissioner Robert Califf. “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.”
Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. It granted the application to approve Narcan nasal spray for OTC use priority review status. Members of an advisory committee meeting in February 2023 voted unanimously to recommend it be approved for marketing without a prescription.
The approval of OTC Narcan nasal spray will require a change in the labeling for the currently approved 4 mg generic naloxone nasal spray products that rely on Narcan as their reference listed drug product. The FDA will require manufacturers of these products to submit a supplement to their applications to effectively switch their products to OTC status. The approval may also affect the status of other brand-name naloxone nasal spray products of 4 mg or less, but the agency will make the determinations on a case-by-case basis.
“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 Patrizia Cavazzoni, 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. Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.”
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