Narcan, overdose-reversing drug, is accredited for OTC gross sales by the FDA : NPR

The opioid overdose reversal drug Narcan (proven right here on the Unitarian Universalist Congregation of Charleston in Charleston, W.Va., on Sept. 6, 2022) has been accredited for over-the-counter gross sales.

Leah Willingham/AP

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Leah Willingham/AP

The opioid overdose reversal drug Narcan (proven right here on the Unitarian Universalist Congregation of Charleston in Charleston, W.Va., on Sept. 6, 2022) has been accredited for over-the-counter gross sales.

Leah Willingham/AP

The overdose-reversing drug Narcan might quickly be available for purchase over-the-counter with no prescription, the Meals and Drug Administration introduced Wednesday.

The FDA’s approval of the nasal spray Narcan — the model identify for the drug naloxone — means the remedy may very well be extra extensively accessible throughout the U.S. because the nation continues to grapple with an opioid epidemic.

“In the present day’s motion paves the best way for the life-saving remedy to reverse an opioid overdose to be offered on to shoppers in locations like drug shops, comfort shops, grocery shops and fuel stations, in addition to on-line,” the FDA mentioned in a press release.

Emergent BioSolutions, the drug firm that produces Narcan, mentioned on Wednesday that it hoped to make the nasal spray accessible on retailer cabinets and at on-line retailers by late summer time. It didn’t instantly say how a lot it might price.

“In the present day’s landmark FDA OTC approval for Narcan Nasal Spray marks a historic milestone as we now have delivered on our dedication to make this necessary emergency remedy extensively accessible, given the alarming charges of opioid overdoses occurring throughout the nation,” Emergent BioSolutions CEO Robert G. Kramer mentioned in a press release.

Some state and metropolis governments in addition to harm-reduction teams have provided naloxone at no cost to residents, and pharmacies already can promote the remedy with no prescription, because of quite a lot of standing orders, state legal guidelines and different actions.

However this patchwork can nonetheless go away some individuals behind or require them to get Narcan behind the counter, which comes with some stigma.

Public well being specialists, harm-reduction advocates and lots of politicians have argued that these limitations meant fewer individuals would get the life-saving remedy they wanted in time. The brand new FDA approval has been praised for making Narcan much more accessible.

The FDA approval comes because the U.S. continues to see a staggering variety of opioid-related deaths, pushed largely by the unfold of artificial opioids similar to illicit fentanyl.

In keeping with knowledge from the Facilities for Illness Management and Prevention, there have been 101,751 reported deadly overdoses within the 12-month interval ending in October.

“We are able to stop overdoses and save lives by making naloxone extra accessible, and on the identical time, we are able to guarantee equitable entry to important well being care,” Well being and Human Companies Secretary Xavier Becerra mentioned in a press release.

Nonetheless, overdose prevention advocates warn that if the price of over-the-counter Narcan is just too excessive — at one level it had a discounted worth of $38 per dose — it might be too costly for some.

“Whereas we welcome #naloxone in any type being accessible over-the-counter, we’re echoing the necessity for naloxone to be free and accessible for all,” the Nationwide Hurt Discount Coalition mentioned in a tweet.

Naloxone, which is available in a nasal spray and an injectable drug, can reverse the results of an opioid overdose and restore an individual’s respiratory. Opioids embrace heroin, fentanyl, oxycodone and morphine.

Indicators of an overdose embrace bluish lips and nostril, irregular respiratory and an absence of responsiveness. A couple of dose of naloxone could also be essential to reverse an overdose.

An FDA advisory committee voted unanimously final month to approve Narcan for over-the-counter gross sales with no prescription.

The precise dose accredited for retail gross sales is the 4 milligram (mg) naloxone hydrochloride nasal spray. Different formulations and dosages of the drug would nonetheless require a prescription, the FDA mentioned.

The administration first accredited Narcan nasal spray in 2015 as a prescription drug.