The FDA has granted OTC approval of Narcan 4 milligram (mg) naloxone hydrochloride nasal spray to Emergent BioSolutions; the first naloxone product approved for use without a prescription.
Naloxone reverses the effects of opioid overdose. Recreational fentanyl use has led to a major public health issue in the United States, with more than 101,000 fatal overdoses occurring last year, primarily due to illegal sale and use.
Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. To change the status of a drug from prescription to nonprescription, the manufacturer provided data demonstrating that the drug is safe and effective and that consumers can understand how to use it without the supervision of a healthcare professional. An advisory committee meeting in February 2023 voted unanimously to recommend it be approved for marketing without a prescription.
