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FDA Takes Steps Toward Reducing Opioid Overdose Deaths

The CDC reports that there were over 100,000 overdose-related deaths in the past year, a large proportion of those deaths attributable to synthetic opioids such as fentanyl. In a major step toward harm reduction, the Food and Drug Administration (FDA) approved Narcan as an over-the-counter medication on March 29, 2023. Narcan is a fast-acting, naloxone hydrochloride nasal spray that reverses the effects of opioid overdoes. Narcan first emerged as an FDA-approved prescription medication in 2015 and manufacturers have been working since that time to demonstrate Narcan’s safety and effectiveness in order to make Narcan available over-the-counter with some states and city governments already offering programs that provide free naloxone. FDA approval allows the sale of Narcan in drug stores, gas stations, grocery stores, online, and more, without a prescription, a move that will greatly increase access to this life-saving medication at the national level. Additionally, advocates highlight that over-the-counter access reduces stigma of having to seek a prescription and potentially involve insurance in order to obtain Narcan. It will likely be several months before Narcan becomes available as manufacturers work to finalize plans for pricing, product labeling, and availability. This approval will likely result in several other naltrexone products seeking over-the-counter status to further increase product availability. FDA leadership reports that they are willing to work with manufacturers to assist in the transition of naltrexone products from prescription to over-the-counter status. Though this approval is a critical step forward in harm reduction, advocates are calling for reduced- or no-cost naloxone options. See the links for additional details: