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# FDA Strategy on Opioid Reversal Products Nears Fruition
- URL: https://www.fdaweb.com/fda-strategy-on-opioid-reversal-products-nears-fruition/
- Published: 2023-02-02T12:00:00.000Z
- Updated: 2026-09-14T18:14:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153686

FDA in a new [online post](https://www.fda.gov/drugs/news-events-human-drugs/our-perspective-cders-continued-efforts-widen-naloxone-access?utm%5Fmedium=email&utm%5Fsource=govdelivery) is outlining its current strategy to expand access to overdose reversal products that has culminated in upcoming advisory committee meetings to consider two “priority review” nonprescription naloxone applications. A 2/15 meeting ([see story](http://fdaweb.com/login.php?sa=v&aid=D5153499&cate=&stid=%241%24NP..SW1.%24JTVUu2u6tgDu9.NvofJKW0&ref=fdaweb.com)) will discuss Narcan (naloxone hydrochloride) nasal spray submitted by Emergent BioSolutions, and a 3/20 meeting ([see story](https://www.fdaweb.com/panel-to-discuss-non-rx-naloxone-spray/)) will address RiVive (naloxone hydrochloride) nasal spray submitted by Harm Reduction Therapeutics. The agency intends to ask the expert panels for advice on the adequacy of the data supporting each application, according to the agency post, noting that the products represent potential first-in-class products in a new therapeutic category for nonprescription drugs.

The submissions follow several FDA efforts to persuade manufacturers to seek such approvals, with the latest being an 11/22 notice, [*Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use*](https://www.federalregister.gov/documents/2022/11/16/2022-24874/safety-and-effectiveness-of-certain-naloxone-hydrochloride-drug-products-for-nonprescription-use?ref=fdaweb.com), announcing a preliminary assessment that certain naloxone drug products may be approvable as safe and effective for nonprescription use. “This preliminary assessment is intended to help facilitate development and approval of nonprescription naloxone products,” FDA says. “However, this is not a final determination that certain naloxone drug products are safe and effective for nonprescription use.”

Next on FDA’s agenda is a 3/8-9 workshop entitled [Understanding Fatal Overdoses to Inform Product Development and Public Health Interventions to Manage Overdose, in partnership with the Reagan-Udall Foundation](https://www.fda.gov/drugs/news-events-human-drugs/understanding-fatal-overdoses-inform-product-development-and-public-health-interventions-manage?ref=fdaweb.com). The agency says the workshop is intended to support “efforts to develop products and approaches to treat overdose and prevent fatalities… Participants will discuss epidemiological trends, drug supply changes, naloxone and other public health interventions to manage overdose, and drug development opportunities.”