FDA Approves First OTC Naloxone Nasal Spray to Reverse Effects of Opioid Overdose

The FDA has approved OTC naloxone hydrochloride 4 mg (Narcan; Emergent BioSolutions) nasal spray for nonprescription use, marking the first approval of a naloxone product for use without a prescription. The approval of OTC naloxone, which can rapidly reverse the effects of opioid overdose, allows for the product to be sold directly to consumers in pharmacies, convenience stores, grocery stores, gas stations, and online.¹

“The FDA remains committed to addressing the evolving complexities of the overdose crisis. 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,” said FDA Commissioner Robert M. Califf, MD, in a press release.¹ “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.”

In February, 2 panels of FDA advisors unanimously voted to recommend naloxone be made available without a prescription.² Some panel members raised concerns about confusing packaging and instructions reported by some participants in a company study; however, Emergent BioSolutions said it would revise the packaging and instructions to address those issues. The committee also urged the FDA to act quickly on the recommendation, rather than waiting for a follow-up study with the new packaging and instructions.

“This favorable recommendation marks another important step forward to broaden access to Narcan Nasal Spray for those who may be at risk of an opioid overdose,” said Paul Williams, senior vice president and products business head at Emergent BioSolutions, in a prior press release.²

High rates of opioid-related deaths are a major issue in the United States and were only exacerbated by the COVID-19 pandemic. CDC data show that 107,000 Americans died from a drug overdose in 2021, of which more than 70,000 were the result of synthetic opioids containing fentanyl.³

Other research has found a 113% increase in the “Years of Life Lost” (YLL) among adolescents and youth in the United States due to unintentional drug overdose. YLL is the difference between the age at which a person dies and their expected remaining lifespan, according to researchers at the Ohio State University Wexner Medical Center.

Their study found that the number of adolescent YLL to unintentional drug overdose more than doubled from 39,579 in 2019 to 84,179 in 2020, after remaining relatively stable between 2016 and 2019.³ Synthetic opioids, including primarily illicitly manufactured fentanyl, contributed to 68,356 YLL, compared to 26,628 in 2019. Additionally, YLL to unintentional overdose during 2020 was higher for males (59,274) than females (24,905).³

The timeline for the availability and the cost of OTC 4 mg naloxone nasal spray will be determined by Emergent BioSolutions, according to the FDA. The agency noted that it will work with all stakeholders to facilitate continued access to naloxone nasal spray products while the product is switched from prescription to OTC status.

The agency noted this transition may take months and that other formulations and dosages of naloxone will remain prescription only.

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

References

1. FDA Approves First Over-the-Counter Naloxone Nasal Spray. FDA. News release. March 29, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray?utm_medium=email&utm_source=govdelivery

2. Antrim, A. FDA Advisory Committees Recommend Naloxone Be Available OTC. Pharmacy Times. February 16, 2023. https://www.pharmacytimes.com/view/fda-advisory-committees-recommend-naloxone-be-available-otc

3. ‘Years of Life Lost’ to unintentional drug overdose in adolescents spikes during pandemic. News release. Ohio State University Wexner Medical Center. September 13, 2022. Accessed February 16, 2023. https://wexnermedical.osu.edu/mediaroom/pressreleaselisting/years-of-life-lost-to-unintentional-drug-overdose-in-adolescents-spikes-during-pandemic