FDA creates faster way to access over-the-counter naloxone products to treat opioid overdoses

The following is cross-posted from our Optum Insights—Government Affairs blog

The U.S. Food and Drug Administration (FDA) recently established a more rapid path for pharmaceutical companies to add over-the-counter (OTC) naloxone products to the market to increase access to naloxone – a life-saving medication used for the emergency treatment of opioid-related overdose – and help reduce opioid-related overdose deaths.

Current FDA-approved naloxone products (e.g., Narcan® Nasal Spray, Evzio® auto-injector) require a prescription and may be costly, depending on the brand. The FDA believes that requiring a prescription may be a barrier to someone who is not under the care of a prescriber or may be afraid of admitting to suffering from substance abuse from prescription opioid analgesics (e.g., Vicodin®, OxyContin®, Percocet®) or illicit substances, such as heroin. For this reason, approving OTC naloxone products is one way to improve access to consumers. In addition, this may result in lowering the cost of these medications.

To encourage companies to enter the OTC market, the FDA developed two drug facts labels (DFLs) with easy-to-understand pictograms aimed at helping people better understand how to use naloxone. The FDA has made available these two consumer-tested model DFLs – one for use with naloxone nasal spray and one for use with a naloxone auto-injector. Additionally, the supporting FDA review will help speed up and streamline the approval process. The FDA is now urging companies to take advantage of this new pathway and submit applications for OTC naloxone products as soon as possible.

For more information on this subject from the FDA Commissioner, please click here.

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  1. U.S. Food and Drug Administration. News & Events. Newsroom. Press Announcements. FDA Statement. January 17, 2019. 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. Available at:https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629571.htm/.
  2. CNBC. Health and Science. FDA clears the way to increase access and lower cost of life-saving opioid overdose treatment drug. January 18, 2019. Available at: https://www.cnbc.com/2019/01/16/fda-wants-pharma-to-bring-opioid-antidote-naloxone-over-the-counter.html.

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