FDA Advisory Committees Recommend Naloxone Be Available OTC

Two panels of FDA advisors unanimously voted to recommend that naloxone (Narcan; Emergent BioSolutions) be made available without a prescription, which, if approved, would be a significant effort to address opioid overdose-related deaths.¹

The FDA will make a final decision in the coming weeks and has a Prescription Drug User Fee Act goal date of March 29, 2023. According to reporting by the Associated Press, some panelists raised concerns about confusing packaging and instructions reported by some participants in a company study.2 Emergent BioSolutions said it would revise the packaging and instructions to address those issues.¹

Committee members also urged the FDA to act quickly on their recommendation, rather than waiting for a follow-up study with the new packaging and instructions.²

“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 press release. “Today’s vote reaffirms our confidence in the safe and effective use of Narcan in the community setting.”

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.¹

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

“Our findings contribute to an emerging body of research documenting adolescent overdose and the impact of fentanyl across communities and this vulnerable population,” said first author Sarah Perou Hermans, MD, in a press release. “The death of a single adolescent to accidental drug overdose is unacceptable. We have sounded the alarm. Now it is time to start putting out the fire.”

Narcan is the leading version of naloxone in the United States and is available both as a prefilled nasal device and an injection. Only the prefilled nasal spray would be made available OTC. Emergent Biosolutions was the first company to submit a supplemental New Drug Application for the OTC status and received Priority Review.

Making naloxone widely available without a prescription is a crucial step to improve access. Although naloxone is already available without a prescription in all 50 states, with standing orders for pharmacists to sell the drug to anyone who asks for it, not all pharmacies carry it and those that do must keep it behind the counter.² If approved by the FDA, the switch to OTC would allow the drug to be sold in vending machines, convenience stores, and supermarkets, as well as on pharmacy retail shelves.²

“Bystanders are present at nearly half of fatal overdoses, yet naloxone is administered in only a small percentage of those cases,” said Joshua Lynch, DO, EMT-P, FAAEM, FACEP, clinical associate professor of emergency and addiction medicine at the University at Buffalo Jacobs Schools of Medicine and Biomedical Sciences, in the press release. “The reality is accidental overdoses can happen to anyone, anywhere, at any time, and we can all do our part by being prepared to help like we would in any other emergency. With access to over-the-counter naloxone, we would have a critical opportunity to close this gap and reduce the number of opioid-related deaths.”¹

REFERENCES

1. Emergent BioSolutions Reports FDA Advisory Commitees’ Unanimous Vote in Favor of Narcan (naloxone HCI) Nasal Spray for Over-the-Counter Use. News release. Emergent BioSolutions; February 15, 2023. Accessed February 16, 2023. https://investors.emergentbiosolutions.com/news-releases/news-release-details/emergent-biosolutions-reports-fda-advisory-committees-unanimous
2. Perrone M. Panel backs moving opioid antidote Narcan over the counter. Associated Press. February 15, 2023. Accessed February 16, 2023. https://apnews.com/article/business-medication-opioids-health-38ae986009788501bc418fe108593632
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