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March 27, 2023FDA Approves First Over-the-Counter Naloxone Nasal Spray
March 29, 2023March 29, 2023 - The FDA approved Emergent BioSolutions’ Narcan (naloxone hydrochloride) 4 mg nasal spray as an over-the-counter (OTC) emergency treatment for opioid overdose. This is the first naloxone product approved for use without a prescription.
Narcan nasal spray was first approved as a prescription drug by the FDA in 2015. In February 2023, an FDA advisory committee unanimously voted in favor of making naloxone nasal spray available for marketing without a prescription. The FDA’s prescription-to-OTC approval of Narcan was bolstered by human factors study data, an updated Drug Facts label, pharmaco vigilance data collected from various public sources, and 7 years of post-marketing safety data. Emergent also submitted data showing consumers can understand how to use Narcan safely and effectively without the supervision of a healthcare professional.
After making necessary manufacturing changes for non-prescription packaging and supply chain modifications, Emergent anticipates Narcan will be available in the United States by late summer 2023. Meanwhile, the prescription product will remain available through pharmacies (via standing order or co- prescription laws) and through community distribution channels.
The OTC version of Narcan will have the same formulation, device design, and strength (4 mg) as the original prescription product. The pricing of the OTC product has not yet been released by the manufacturer.
The FDA stated that the approval of Emergent’s Narcan nasal spray as an OTC product will require a change in the labeling for the currently approved 4 mg generic naloxone nasal spray products that use Narcan as their reference listed drug product. Manufacturers of these products will need to submit a supplement to their FDA application to switch their products to OTC status. The approval of OTC Narcan may also affect the status of other brand-name naloxone nasal spray products of 4 mg or less, but the FDA will make determinations on a case-by-case basis.
With FDA approval of nonprescription Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray, HHS will launch a department-wide approach to work with stakeholders to implement the Narcan switch from prescription to nonprescription status, facilitate the continued availability of naloxone nasal spray products during the time needed to implement the transition, and help ensure appropriate coverage and continued access to all forms of naloxone.