The U.S. Food and Drug Administration on Wednesday approved its first opioid reversal drug, Narcan, for over-the-counter, nonprescription use.
“Today’s action paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online,” the FDA said in a press release.
Narcan, the brand name of the nasal spray naloxone, will switch from prescription to over-the-counter status within the next several months, the agency said. Prescriptions will still be required for other formulations and dosages of naloxone.
Last fiscal year, which ran from October 2021 to October 2022, more than 101,750 fatal drug overdoses occurred in the United States, largely driven by synthetic opioids such as fentanyl.
“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,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said.