The FDA has approved Narcan (4 mg naloxone hydrochloride nasal spray) for over-the-counter (OTC) use, making it the first naloxone product available without a prescription. Narcan is a life-saving medication that rapidly reverses the effects of opioid overdoses, and this decision allows it to be sold directly to consumers in pharmacies, grocery stores, convenience stores, gas stations, and online.

This approval comes at a critical time, as the opioid crisis continues to devastate the United States. In the 12 months ending October 2022, there were more than 101,750 reported overdose deaths, with synthetic opioids like illicit fentanyl being the primary cause. By making Narcan more accessible, the FDA aims to provide individuals, families, and communities with a vital tool to combat opioid overdoses and potentially save lives.

Narcan was first approved as a prescription drug in 2015. To support this switch to OTC status, the manufacturer, Emergent BioSolutions, provided data showing that consumers can understand how to use the medication safely and effectively without medical supervision. While Narcan will soon be available over the counter, other formulations and dosages of naloxone will remain prescription-only for now.

The timeline for availability and pricing will depend on the manufacturer. The FDA is encouraging Emergent BioSolutions to ensure the product is widely accessible and affordable as soon as possible. The agency has also committed to working with other manufacturers to facilitate the transition of generic naloxone nasal sprays to OTC status.

This approval is part of the FDA’s broader strategy to address the opioid crisis through harm reduction and increased access to treatment. The agency continues to support efforts that make naloxone more available to the public, reduce barriers to obtaining it, and ultimately help prevent opioid-related deaths.

By making Narcan available without a prescription, the FDA hopes to empower more people to act quickly in emergencies, ensuring that this life-saving medication is within reach when it is needed most.