NCHR Comments on the FDA Preliminary Assessment of Potential Non-prescription Naloxone Products

January 17, 2023

Thank you for the opportunity to express our views on the Food and Drug Administration (FDA) preliminary assessment regarding potential non-prescription use of certain naloxone products. The National Center for Health Research (NCHR) is a non-profit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety, with a strong focus on medical products. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We agree with the FDA’s assessment that certain types of naloxone drug products could be safe and effective for non-prescription use without medical supervision if used correctly. We agree that the dosage should be limited: up to 4 milligrams of the naloxone nasal spray and up to 2 milligrams of naloxone auto-injector for intramuscular or subcutaneous use.  We strongly agree with the FDA’s assessment that well-designed research is needed on the safety and efficacy of non-prescription use for all naloxone products. Naloxone is a life-saving tool that reverses the immediate effects of opioid overdose, preventing numerous deaths that would have been caused by opioid use. A study of opioid overdoses in San Francisco found that of the 702 naloxone administrations, only 10 did not survive1. In one New York county, researchers found that naloxone administration, whether done by emergency medical responders or family and friends was successful 81% of the time (653 of 800 reported overdoses).2 A statistical model designed by public health experts Townsend et. al found that greater access to naloxone for lay people resulted in 107 overdose deaths compared to 136 deaths the low distribution model, a 21% decrease3. However, we understand there are concerns about how effectively members of the general population in the United States can administer naloxone and whether widespread access to naloxone could reduce caution among some drug users. Research is needed to address those questions.

To improve naloxone safety and effectiveness, it is necessary to implement appropriate training for community and layperson use. For example, a 2020 study found that volunteers or community members with a smartphone app designed to alert others about a nearby overdose responded 5 or more minutes more quickly than traditional emergency services in about 59% of cases. 95% of reports of overdose through the app resulted in a successful naloxone intervention by laypersons.4 In a 2015 literature review that assessed studies on naloxone education and lay distribution effectiveness found that of the 66 reports of opioid overdose, naloxone was administered 39 times with no deaths reported following naloxone use.5 We recommend continued training of the proper use of naloxone in communities across the country.

Nevertheless, more data are needed on the effectiveness of labeling on non-prescription naloxone products. Following a 2019 Federal Register notice, the FDA provided a draft model for companies wishing to submit a new drug application to refer to when designing a label for over-the-counter naloxone products. We look forward to seeing new applications submit concise, easy-to-understand, step-by-step instructions to the lay public on how to administer naloxone.

 

 

 

 

 

  1. Rowe C, Santos GM, Vittinghoff E, et al.Predictors of participant engagement and naloxone utilization in a community-based naloxone distribution program. Addiction 2015; 110: 1301–1310

 

  1. Heavey, S.C., Delmerico, A.M., Burstein, G. et al. Descriptive Epidemiology for Community-wide Naloxone Administration by Police Officers and Firefighters Responding to Opioid Overdose. J Community Health 43, 304–311 (2018). https://doi.org/10.1007/s10900-017-0422-8

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  1. Townsend, T., et al., Cost-effectiveness analysis of alternative naloxone distribution strategies: First responder and lay distribution in the United States. International Journal of Drug Policy, 2019.
  2. Schwartz DG, Ataiants J, Roth A, Marcu G, Yahav I, Cocchiaro B, Khalemsky M, Lankenau S. Layperson reversal of opioid overdose supported by smartphone alert: A prospective observational cohort study. EClinicalMedicine. 2020 Aug 3;25:100474. doi: 10.1016/j.eclinm.2020.100474. PMID: 32954238; PMCID: PMC7486335

 

 

  1. Giglio, R.E., Li, G. & DiMaggio, C.J. Effectiveness of bystander naloxone administration and overdose education programs: a meta-analysis. Epidemiol. 2, 10 (2015). https://doi.org/10.1186/s40621-015-0041-8.