Updated March 29, 2023 at 3:10 PM ET
The overdose-reversing drug Narcan could soon be available to buy over the counter without a prescription, the Food and Drug Administration announced Wednesday.
The FDA's approval of the nasal spray Narcan — the brand name for the drug naloxone — means the medication could be more widely available across the U.S. as the country continues to grapple with an opioid epidemic.
"Today's action paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online," the FDA said in a statement.
Emergent BioSolutions, the drug company that produces Narcan, said on Wednesday that it hoped to make the nasal spray available on store shelves and at online retailers by late summer. It did not immediately say how much it would cost.
"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," Emergent BioSolutions CEO Robert G. Kramer said in a statement.
Some state and city governments as well as harm-reduction groups have offered naloxone for free to residents, and pharmacies already can sell the medication without a prescription, thanks to a variety of standing orders, state laws and other actions.
But this patchwork can still leave some people behind or require them to get Narcan behind the counter, which comes with some stigma.
Public health experts, harm-reduction advocates and many politicians have argued that those barriers meant fewer people would get the life-saving medication they needed in time. The new FDA approval has been praised for making Narcan even more accessible.
The FDA approval comes as the U.S. continues to see a staggering number of opioid-related deaths, driven in large part by the spread of synthetic opioids such as illicit fentanyl.
According to data from the Centers for Disease Control and Prevention, there were 101,751 reported fatal overdoses in the 12-month period ending in October.
"We can prevent overdoses and save lives by making naloxone more accessible, and at the same time, we can ensure equitable access to essential health care," Health and Human Services Secretary Xavier Becerra said in a statement.
Still, overdose prevention advocates warn that if the cost of over-the-counter Narcan is too high — at one point it had a discounted price of $38 per dose — it may be too expensive for some.
"While we welcome #naloxone in any form being accessible over-the-counter, we're echoing the need for naloxone to be free and accessible for all," the National Harm Reduction Coalition said in a tweet.
Naloxone, which comes in a nasal spray and an injectable drug, can reverse the effects of an opioid overdose and restore a person's breathing. Opioids include heroin, fentanyl, oxycodone and morphine.
Signs of an overdose include bluish lips and nose, abnormal breathing and a lack of responsiveness. More than one dose of naloxone may be necessary to reverse an overdose.
An FDA advisory committee voted unanimously last month to approve Narcan for over-the-counter sales without a prescription.
The specific dose approved for retail sales is the 4 milligram (mg) naloxone hydrochloride nasal spray. Other formulations and dosages of the drug would still require a prescription, the FDA said.
The administration first approved Narcan nasal spray in 2015 as a prescription drug.
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