Narcan is a brand of naloxone, a drug that can be used to reverse opioid overdoses. The nasal spray is simple to use and can reverse the effects of dangerous drugs like heroin and fentanyl. While the drug has previously required a prescription, public health officials and activist groups have offered trainings and distributed the medication to the general public.
“Naloxone is a critical tool in addressing opioid overdoses, and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
Overdose deaths, driven primarily by synthetic opioids like fentanyl, have impacted communities around the country. In the fiscal year ending in October 2022, there were 101,750 reported fatal overdoses.
FDA Commissioner Dr. Robert M. Califf said the decision is a response to a public health emergency.
“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price,” Califf said.
While Narcan nasal spray has been approved for general sale, other naloxone products will remain prescription only.
Manufacturers will be able to set their own prices for Narcan and will control the timeline of when it will be widely available. However, by late summer, it is expected to be widely available at retail pharmacies, grocery stores, gas stations, vending machines and other retailers.