FDA takes steps to make naloxone OTC

Charlie Sieberg, Pharm.D., New Ulm Medical Center

According to FDA Commissioner Scott Gottlieb, MD, overdose deaths involving prescription and illicit opioids is a growing problem in the U.S. with nearly 48,000 deaths in 2017. Naloxone is currently being used to combat this epidemic as it rapidly reverses opioid overdose effects after administration. Availability of this life-saving medication is a potential barrier for people who aren’t under the care of a physician, or for those who may be afraid or embarrassed of admitting to issues with substance abuse, due to its prescription status.

The FDA is working to overcome this barrier by encouraging drug companies to develop OTC naloxone products. All OTC products would require a consumer-friendly Drug Facts Label (DFL) that ensures consumers can understand how to use the product without the supervision of a healthcare professional. For the first time, the FDA has proactively developed and tested consumer comprehension of two naloxone DFLs, one for a nasal spray and one for an auto-injector, that drug companies can use to obtain approval for an OTC formulation. Consumer comprehension of these DFLs were successfully tested by over 700 participants including people who use heroin, people who use prescription opioids, family and friends of people who use opioids, adolescents, and the general public.

Manufacturers now have the option to simply add product specific information to the model DFL for final comprehension testing and do not have to generate an entire DFL independently. The FDA is hopeful these model DFLs will jumpstart the development of OTC naloxone products and increase access to this life-saving medicine.


  1. U.S. Food & Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., on unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629571.htm Published January 17, 2019. Accessed February 18, 2019.