Feds Greenlight Expanded Naloxone Availability

By Jonathan Springston, Editor, Relias Media

The FDA has approved naloxone nasal spray, a medication used to reverse the effects of an opioid overdose, for over-the-counter (OTC) sales.

“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,” said FDA Commissioner Robert M. Califf, MD, on Wednesday. “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.”

The FDA approved Narcan nasal spray for prescription in 2015. In 2022, the agency indicated naloxone could be safe for OTC sales. Earlier this year, Narcan’s manufacturer applied and submitted data for OTC approval, which the FDA approved.

“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 Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status. Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.”

The American Medical Association (AMA) said it “strongly supports” the OTC sale of naloxone spray, predicting this move “will transform how we compassionately and logically respond to the overdose epidemic.” The AMA called on all naloxone manufacturers to submit OTC applications and for retailers to work with these drug companies to make the agents prominent on store shelves.

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