Empower Patients to Use OTC Naloxone Safely

Due to the ongoing opioid crisis and the alarming number of overdose deaths attributed to opioid misuse and abuse, the FDA and other health agencies, such as the CDC, the Substance Abuse and Mental Health Services Administration, and the US Department of Health and Human Services, are continually implementing measures to address this critical and ongoing public health issue.

According to statistics from the CDC, the number of opioid fatalities increased significantly between 1999 and 2023. However, 2023 saw the first annual decline since 2018.¹ In 2023, an estimated 105,000 deaths were the result of drug overdoses, with an estimated 80,000 (76%) of those involving opioids. In the same year, there were approximately 10 times as many deaths from opioid overdoses compared with 1999, although the opioid overdose death rate decreased by 4% from 2022 to 2023.¹

Published literature indicates that drug overdose is the leading cause of accidental death in the US, with opioids being the most common culprit. The CDC estimates that more than 1000 emergency department visits occur each day due to opioid misuse, and approximately 91 Americans die daily from an opioid overdose.^2,3 The CDC also emphasizes that it is possible to save more lives by broadening efforts via effective patient education initiatives aimed at overdose prevention and increasing awareness of the opioid crisis.¹

Overview of Naloxone and Recent Approval of Intranasal OTC Naloxone Formulations

Naloxone is a lifesaving drug, and the most recent statistics from the CDC indicate that more than 2.1 million naloxone prescriptions were dispensed from retail pharmacies in 2023, with the overall rate of naloxone dispensed from retail pharmacies in the US increasing from 0.3 to 0.6 per 100 persons from 2019 to 2023.⁴

In an effort to improve access to naloxone, in March 2023 the FDA approved 4-mg naloxone hydrochloride nasal spray (Narcan; Emergent BioSolutions) for OTC use, making it the first naloxone product approved for use without a prescription.⁵ The FDA indicates that naloxone for OTC use is safe, effective, and easy to administer and can swiftly reverse the effects of a known or suspected opioid overdose.⁵

In July 2023, the FDA approved 3-mg naloxone hydrochloride nasal spray, marketed as RiVive (Harm Reduction Therapeutics, Inc), for OTC use to treat known or suspected opioid overdose, marking the second OTC naloxone product approved by the FDA and increasing consumer access to naloxone without a prescription.⁶

There are also some generic formulations of OTC naloxone available. It is also important to note that naloxone strengths greater than 4 mg are still available by prescription only and in other dosage formulations.⁷ Pharmacists are instrumental in providing patients with critical information about the safe and proper usage of OTC naloxone.

News and Recent Research

Study findings published in the Journal of Substance Use & Addiction Treatment examined the first year of OTC naloxone sales in states with some of the highest opioid overdose mortality, including Kentucky, Massachusetts, New York, and Ohio. The authors reported rapid adoption after OTC status, suggesting that OTC availability meaningfully expanded naloxone access in communities with the highest rates of overdose. However, cost may be a barrier to access for some consumers.⁸

Separate study findings published in the Journal of the American Pharmacists Association examined the perspectives of rural community pharmacists in the southern US regarding the transition to OTC naloxone. Findings revealed that pharmacists are generally in favor of increased access but face ongoing challenges, including community stigma, staffing shortages, and concerns about patients’ understanding of the proper use and timing of naloxone.⁹

On January 14, 2026, the FDA approved a supplemental new drug application for OTC Narcan, introducing a new carrying case with 2 blister packs, each containing a quick start guide. This packaging is designed to be portable, discreet, and durable, aiming to encourage people to keep lifesaving Narcan nasal spray accessible during opioid emergencies.¹⁰

Table 1^11,12 below highlights key information to relay during patient counseling.

Conclusion

Pharmacists can assist patients in recognizing the signs of opioid overdose, provide instructions on how to properly prepare and administer the OTC naloxone formulations via the nasal route, explain what to expect after administering the medication, and explain the importance of calling 911 for proper medical care and evaluation.

Pharmacists can also assist patients by offering guidance when needed, directing patients to valuable resources about opioid addiction and safe opioid use, and encouraging patients to discuss any concerns with their primary health care providers.¹³

Table 2 provides valuable patient resources on preventing opioid overdose and proper use of these products.

REFERENCES

1. Understanding the opioid overdose epidemic. CDC. June 9, 2025. Accessed January 13, 2026. https://www.cdc.gov/overdose-prevention/about/understanding-the-opioid-overdose-epidemic.html

2. Regina AC, Goyal A, Mechanic OJ. Opioid toxicity. In: StatPearls. StatPearls Publishing; 2025. Accessed February 17, 2026. https://www.ncbi.nlm.nih.gov/books/NBK470415/

3. Opioid education. Narcan. 2024. Accessed January 14, 2026. https://narcan.com/en/opioid-education

4. Naloxone dispensing rate maps. CDC. November 7, 2024. Accessed February 17, 2026, 2026. https://www.cdc.gov/overdose-prevention/data-research/facts-stats/naloxone-dispensing-rate-maps.html

5. FDA approves first over-the-counter naloxone nasal spray. News release. FDA. March 29, 2023. Accessed January 14, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray

6. FDA approves second over-the-counter naloxone nasal spray product. News release. FDA. July 28, 2023. Accessed January 14, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-second-over-counter-naloxone-nasal-spray-product

7. Rumore M. Legal and regulatory issues in self‑care pharmacy practice. In: Krinsky DL, Ferreri SP, Hemstreet B, et al, eds. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 21st edition. American Pharmacists Association; 2024. Accessed February 17, 2026.

8. Gammon DG, Gaber J, Saunders M, Zarkin GA. Estimates of first-year OTC naloxone sales in four US states with high rates of opioid overdose deaths: KY, MA, NY, OH. J Subst Use Addict Treat. 2025;178:209762. doi:10.1016/j.josat.2025.209762

9. Gravlee E, Wartman C, Rosenthal M. Over-the-counter naloxone availability: insights from rural community pharmacists in the Southern United States. J Am Pharm Assoc (2003). 2025;65(3):102357. doi:10.1016/j.japh.2025.102357

10. Emergent BioSolutions receives US FDA approval on supplemental new drug application for Narcan nasal spray to be packaged in a new carrying case, making life-saving naloxone more accessible for everyday preparedness. News release. Emergent BioSolutions. January 14, 2026. Accessed February 9, 2026. https://www.globenewswire.com/news-release/2026/01/14/3218575/33240/en/Emergent-BioSolutions-Receives-U-S-FDA-Approval-on-Supplemental-New-Drug-Application-for-NARCAN-Nasal-Spray-to-be-Packaged-in-a-New-Carrying-Case-Making-Life-Saving-Naloxone-More-A.html

11. Narcan nasal spray. Emergent BioSolutions. Accessed January 14, 2026. https://narcan.com/en/healthcare-professionals

12. RiVive. Harm Reduction Therapeutics. Accessed January 14, 2026. https://www.harmreductiontherapeutics.org/rivive/

13. FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder. FDA. July 23, 2020. Accessed January 15, 2026. https://www.fda.gov/drugs/drug-safety-and-availability/fda-recommends-health-care-professionals-discuss-naloxone-all-patients-when-prescribing-opioid-pain