FDA approves overdose drug Narcan as 1st over-the-counter opioid treatment

The Food and Drug Administration on Wednesday approved over-the-counter sales of Narcam, the leading version of the opioid overdose reversal drug naloxone. Narcan is the first opioid treatment to get approval for sale without a prescription, and advocates and the Biden administration hope wider distribution will cut the number of Americans dying from fentanyl, heroin, oxycodone, and other opioid overdoses. Almost two-thirds of the 107,000 U.S. overdose deaths recorded in 2021 were from the synthetic opioid fentanyl.

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Addiction and overdose experts said the efficacy of selling Narcan over the counter will depend on how many stores decide to stock it, where and how they display it on shelves, whether insurance plans will cover it, and how much its manufacturer, Emergent BioSolutions, decides to charge for a two-dose nasal spray package. Currently, the two-dose package of Narcan reportedly sells for about $47.

The FDA is likely to approve a second OTC naloxone spray, RiVine, which the nonprofit Harm Reduction Therapeutics sells for about $18 a unit, The Washington Post reports, and generic versions would be even cheaper if approved.

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The FDA said, after Emergent studied the issue, that Narcan requires no specialty training to administer. One dose typically revives people overdosing on opioids, though fentanyl overdoses can require several doses. Before administering Narcan, people should call 911 and request an ambulance. Emergent said Narcan should be available on store shelves by late summer.