The FDA Approves Rextovy, an OTC Naloxone for Opioid Overdose

The FDA approves Rextovy, a 4-milligram naloxone hydrochloride nasal spray for OTC use to combat the opioid crisis, according to a news release from the agency. This latest approval allows consumers to purchase the lifesaving medication without a prescription at pharmacies, convenience stores, and through online retailers.¹

Acting Director of the FDA’s Center for Drug Evaluation and Research, Mike Davis, noted that the action is intended to broaden access and empower individuals without medical training to intervene during an emergency. The agency hopes that increasing the number of approved nonprescription formulations will foster market competition and potentially reduce the financial burden on consumers.¹

“Access: Part of it can increase because if it’s OTC, gas stations got it, grocery stores got it. It opens up that part, but access also includes cost to the core of your question,” Mark Garofoli, PharmD, BCGP, CPE, CTTS, clinical assistant professor and director of experiential learning at West Virginia University School of Pharmacy, said.² “That's going to differ product to product, and that's going to be very confusing for patients and, quite frankly, health care professionals alike.”

Although the FDA’s 2023 approval of the first OTC naloxone spray was a milestone, recent market data indicates that pharmacists remain the link in the distribution chain. A study examining naloxone sales from September 2023 to September 2024 found that retail OTC sales have been surprisingly limited, averaging only 396 units per million residents. In contrast, pharmacy-distributed naloxone reached an average of 7063 units per million residents during a similar period. Researchers suggested that the disparity may be driven by the high cost of retail products, which averaged nearly $50, making pharmacist-dispensed and state-funded programs more viable options for many.³

For pharmacists, the introduction of Rextovy provides an additional tool to address a public health issue that, while improving, remains a significant threat. National data shows a dramatic decrease in overdose deaths, falling from more than 111,000 reported in the period ending August 2023 to approximately 68,000 by the end of 2025.^1,3

Despite this unprecedented decline, synthetic opioids like illicit fentanyl continue to drive high mortality rates, making immediate access to reversal agents essential. Pharmacists are uniquely positioned to educate the public on the signs of an overdose, such as pinpoint pupils and shallow breathing, and to provide instructions on the proper administration of the nasal spray.^1,3,4

Clinical guidelines for these products emphasize that naloxone is a temporary measure and that professional medical intervention is mandatory. Because the effects of opioids can outlast the reversal agent, breathing problems may return after the initial dose wears off, necessitating a 911 call immediately after administration.⁴

Pharmacists must also prepare caregivers for the likelihood of acute opioid withdrawal symptoms in patients who regain consciousness, which can include shivering, nausea, and intense agitation. By bridging the gap between clinical expertise and community access, pharmacists continue to play a more substantial role in naloxone distribution than traditional retail sales alone.^1,3,4

“In many ways, pharmacists have been absolutely critical in making these transitions work in practice, really helping people understand potential risks and interactions, managing [adverse] effects, and just deciding when self-care is appropriate,” Alyssa Billingsley, PharmD, senior director of pharmacy content at GoodRx, said.⁵ “I think that Rx-to-OTC switches have only reinforced pharmacists’ role as a trusted source of guidance, especially as people are given more choices and more responsibility for their own care.”

READ MORE: OTC Resource Center

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REFERENCES

1. FDA broadens access to over-the-counter naloxone nasal spray for opioid overdose. News release. FDA. June 16, 2026. Accessed June 16, 2026. https://www.fda.gov/news-events/press-announcements/fda-broadens-access-over-counter-naloxone-nasal-spray-opioid-overdose

2. Nowosielski B, Garofoli M. Q&A: pharmacists help patients navigate complexities of OTC medications. Drug Topics. March 25, 2026. Accessed June 16, 2026. https://www.drugtopics.com/view/pharmacists-help-patients-navigate-complexities-of-otc-medications

3. Nowosielski B. Naloxone sales highlight limited OTC use, access challenges. Drug Topics. November 3, 2025. Accessed June 16, 2026. https://www.drugtopics.com/view/naloxone-sales-highlight-limited-otc-use-access-challenges

4. Mayo Clinic. Naloxone (nasal route). May 1, 2026. Accessed June 16, 2026. https://www.mayoclinic.org/drugs-supplements/naloxone-nasal-route/description/drg-20165181

5. Nowosielski B, Billingsley A. Q&A: pharmacist, patient impact of Rx-to-OTC switches. Drug Topics. January 28, 2026. Accessed June 16, 2026. https://www.drugtopics.com/view/pharmacist-patient-impact-of-rx-to-otc-switches