Thursday, March 30, 2023

FDA Approves Naloxone Nasal Spray for Over-the-Counter Sale

The U.S. Food and Drug Administration (FDA) yesterday approved Narcan (naloxone) 4 mg hydrochloride nasal spray for purchase without a prescription. Narcan rapidly reverses the effects of an opioid overdose.

“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,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

The FDA’s action “paves the way” for Narcan to be sold in drugstores, supermarkets, convenience stores, gas stations, and online, according to the release. The medication will be available in retailers and online by the late summer, and it will still be available as a prescription in the meantime.

The over-the-counter (OTC) approval was granted to Emergent BioSolutions, Narcan’s manufacturer. In February, two FDA advisory committees recommended Narcan be made available without a prescription.

According to a news release from the company, the OTC product will have the same formulation, device design, and prescription strength as the original product.

Cavazzoni said in the FDA release that the agency is working with its federal partners to ensure continued access to naloxone during Narcan’s transition to 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,” Cavazzoni added.

APA expressed its support of Narcan for OTC use in a letter to FDA Commissioner Robert M. Califf, M.D., in January, noting that naloxone nasal spray and autoinjector formulations are safe and effective. Further, APA encouraged the FDA to address supply chain issues; education related to opioid overdoses (such as through a package insert that describes the sign of an opioid overdose, outlines how to administer naloxone, and reminds the user to call emergency services); and cost.

“Cost barriers must be mitigated through payers’ coverage of OTC formulations of naloxone,” APA’s letter stated. “For example, Medicare does not pay for some forms of nicotine replacement therapy such as the patch, gum, or lozenges due to [these products] being OTC. APA encourages FDA to work with [the Centers for Medicare and Medicaid Services] and other payers to keep cost down for the most vulnerable populations.”

Finally, APA noted that prescribers should continue to write naloxone prescriptions to patients at risk, as insurers can continue to cover prescription naloxone.

Emergent BioSolutions’ news release did not state the price of OTC Narcan.

For related information, see the Psychiatric News AlertFDA Advisory Panel Recommends Approval for Over-the-Counter Narcan.”

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