On Wednesday, the U.S. Food and Drug Administration announced the approval of over-the-counter sales for Narcan, an overdose-reversing nasal spray. The FDA green light marks the first naloxone product approved for use without a prescription (only the 4-milligram dose of Narcan has been approved; other formulations, including higher dosages and injectable versions of naloxone, will continue to require a prescription.) Naloxone rapidly reverses the effects of an opioid overdose, including in situations where fentanyl is involved. According to the FDA, in the 12-month period ending in Oct. 2022, the United States recorded 101,750 overdose deaths, primarily from opioids including fentanyl.
FDA Commissioner Robert Califf said: “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.”
The decision allows the drug to be made available at drug stores, convenience stores, grocery stores, gas stations, and online shops. It’s not immediately clear when Narcan will be available for over-the-counter sale. The FDA said this timeline will be determined by the product’s manufacturer, Emergent BioSolutions, who said it will be available “by the late summer to account for manufacturing changes that will be implemented to support nonprescription packaging, as well as supply chain modifications.”
Emergent BioSolutions CEO Robert G. Kramer said in a statement: “Today’s landmark FDA OTC approval for Narcan nasal spray 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.”
Walgreens spokesperson Zoe Krey said it would offer Narcan later this year in stores and online: “Delivering access to this lifesaving medication that can reverse the effects of an overdose if administered in time is imperative, and Walgreens is already working with suppliers to bring this OTC medication to shelves.”
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