FDA OKs First OTC Product for Reversing Opioid Overdoses

The FDA approved the first over-the-counter (OTC) naloxone (Narcan) product for treating opioid overdose on Wednesday.

“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 Robert M. Califf, MD, said in a statement.

Fatal drug overdoses continue to be a major public health issue in the U.S., the agency said, citing fatality figures north of 100,000 for the 12-month period ending in October 2022. 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 even online.

The move follows unanimous support from members of the Nonprescription Drug Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee, who in February recommended the agency make the 4-mg nasal spray available without a prescription following a review of data showing the product to be safe and effective for use as directed in proposed labeling. Manufacturer, Emergent BioSolutions, also demonstrated in trial data that consumers could understand how to use the product without a healthcare professional standing by.

While the exact timeline for availability and the price of the OTC product will be determined by Emergent BioSolutions, Califf urged “the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

The agency noted that Wednesday’s approval requires a change in the labeling for other currently approved generic naloxone nasal spray products that relied on Narcan as their reference product. In addition, the approval may affect the status of other similar brand-name products. At this time, other formulations and doses of naloxone will still only be available by prescription, according to the agency.

FDA said it will work with stakeholders during the “switch from prescription to OTC status, which may take months,” to ensure the products continue to be readily available.

“The FDA remains committed to addressing the evolving complexities of the overdose crisis,” Califf said. “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.”

For example, in November 2022 the FDA said a preliminary assessment found that certain naloxone products had the potential to used safely and effective without a prescription, and at the time encouraged sponsors to seek out such an indication. That followed the agency’s “designed, tested, and validated” model for a naloxone drug facts label to guide manufacturers pursuing OTC approvals (the model label was used by Emergent BioSolutions).

While naloxone products can rapidly reverse the effects of an opioid overdose, the agency noted that for individuals who are opioid dependent, the use of naloxone may result in severe withdrawal symptoms, including body aches, sweating, fever, diarrhea, tachycardia, nausea/vomiting, shivering/trembling, yawning, abdominal cramps, and increased blood pressure, among others.

Naloxone nasal spray was first approved as a prescription drug by the FDA in 2015.

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