FDA Approves Over-The-Counter Opioid Antidote As Fentanyl Deaths Surge

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The Food and Drug Administration (FDA) approved Naloxone, an opioid overdose reversal drug, for over-the-counter purchase as fentanyl deaths surge in the U.S., the agency said in a statement Wednesday.

Naloxone, which is commonly known as Narcan, will be available over the counter in drug stores, convenience stores, grocery stores and gas stations, as well as online, the FDA said. The agency’s decision follows 2021’s record of more than 100,000 drug overdose deaths, which were largely caused by fentanyl.

Fentanyl is a synthetic opioid that is considered to be lethal at a dose of just two milligrams, according to the Drug Enforcement Administration (DEA).

“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” FDA Commissioner Robert M. Califf, M.D. said in a statement.

“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.

The FDA approved Narcan as a prescription drug in 2015. Narcan reversed 26,463 overdoses between 1996 and June 2014 after the distribution of 152,283 Narcan kits to a group of surveyed organizations, according to a 2014 Centers for Disease Control and Prevention (CDC) study.

“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,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research said in a statement.

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