FDA Panel Says Opioid Overdose Antidote Safe to Sell Over the Counter

FDA advisers voted unanimously in favor of making the drug easier to access

By Physician’s Briefing Staff HealthDay Reporter

THURSDAY, Feb. 16, 2023 (HealthDay News) — A nasal spray that can reverse an opioid overdose should be sold over the counter, two expert panels to the U.S. Food and Drug Administration recommended Wednesday. Research has shown that wider availability of naloxone (Narcan) could save lives.

The FDA advisers voted unanimously in favor of making the drug easier to access after a daylong meeting that focused on whether untrained users would be able to safely and effectively use the nasal spray in emergencies, the Associated Press reported.

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. The manufacturer, Emergent Biosolutions, said it would revise the packaging and labeling to address those concerns, the AP reported. The FDA will make a final decision on the drug in the coming weeks.

“Perfect should not be the enemy of the good, and the evidence we saw today provides clear indication that the drug can be used without the direction of a health care provider,” said panel member Brian Bateman, M.D., of Stanford University in California.

In a statement, the American Medical Association applauded the panel’s decision. “The AMA believes greater access will occur when naloxone for overdose risk is just as easily accessible in a pharmacy, grocery store and other common locations as acetaminophen for a headache or a decongestant for a stuffy nose,” the group representing doctors said. “We urge the FDA to make a speedy and final determination in favor of over-the-counter access.”

FDA officials who were at the meeting agreed. “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.

Associated Press Article