FDA Approves First Over-the-Counter Nasal Spray for Opioid Overdoses

WEDNESDAY, March 29, 2023 (HealthDay News) — The U.S. Food and Drug Administration on Wednesday approved the over-the-counter (OTC) use of naloxone (Narcan).

“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,” FDA Commissioner Robert Califf, M.D., said in an agency news release. “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.”

Emergent BioSolutions, the Maryland company that makes the Narcan spray, made no mention of price in a statement it released after the FDA approval was announced, but the company’s president applauded the move.

The approval “marks a historic milestone as we have delivered on our commitment to make this important emergency treatment widely accessible, given the alarming rates of opioid overdoses occurring across the country,” Robert Kramer, president and CEO of Emergent BioSolutions, said in a company news release.

The recommendation came despite concerns from some panel members about the clarity of the drug’s instructions and packaging, which caused confusion among some people in a company study. Emergent BioSolutions said it would revise the packaging and labeling to address those concerns, according to the Associated Press.

“We believe that nonprescription naloxone may help address these barriers [in access],” said Jody Green, M.D., the FDA deputy division director for safety for the Division of Nonprescription Drugs. She noted that the switch would allow the drug to be sold in vending machines, convenience stores and supermarkets, the AP reported. Although naloxone is already available without a prescription, it must be obtained directly from a pharmacist.