FDA Approves First OTC Naloxone Nasal Spray for Treatment of Opioid Overdoses

The US Food and Drug Administration (FDA) approved the first over-the-counter (OTC) naloxone product for the emergency treatment of opioid overdose.

The FDA announced the approval of naloxone hydrochloride nasal spray 4 mg (Narcan®, Emergent BioSolutions) in a March 29, 2023, press release. Other formulations and dosages of naloxone will remain available by prescription only, noted the agency.

“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,” said FDA Commissioner Robert M. Califf, MD, in the agency’s statement.

Fatal drug overdoses continue to be a major public health issue in the US, said the FDA, citing fatality figures of more than 101 750 for the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl. The OTC approval paves the way for the nasal spray to be sold directly to consumers in easily accessible locations such as grocery stores, gas stations, and online.

The FDA’s decision to change the status of naloxone nasal spray from prescription to nonprescription was based on data provided by the manufacturer that demonstrated that the drug is safe and effective for use as directed in its proposed labeling. Also, the agency said that the manufacturer showed that consumers can understand how to use naloxone safely and effectively without the supervision of a health care professional.

Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. In December 2022, the FDA accepted a supplemental new drug application for Narcan for OTC use and granted the application priority review. Then, in February 2023, advisory committee members voted unanimously to recommend it be approved for marketing without a prescription.

The agency noted that Wednesday’s approval requires 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. Manufacturers of these products will be required to submit a supplement to their applications to switch their products to OTC status, said the FDA. Also, the approval may affect the status of other brand-name naloxone nasal spray products of ≤4 mg, but “determinations will be made on a case-by-case basis and the FDA may contact other firms as needed,” said the FDA.

“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,” said Patrizia Cavazzoni, MD, director, Center for Drug Evaluation and Research, FDA. “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.”

Emergency BioSolutions anticipates that Narcan will be available in-store and online by the late summer. “In the meantime, the prescription product will remain in readily available supply through current access channels, including pharmacies through standing order or co-prescription laws and through community distribution,” said the company in a March 29, 2023, press release.