SAN FRANCISCO (KCBS RADIO) – For the first time, an over-the-counter opioid overdose antidote has been approved by the U.S. Food and Drug Administration. The nasal spray, Narcan, is expected to “reduce opioid overdose deaths” nationwide.
The FDA approved the drug in a 4-milligram naloxone hydrochloride nasal spray that will be available without the need of a prescription, something many have said could save thousands who die from drug overdoses caused by synthetic opioids.
“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” FDA Commissioner Robert Califf shared in a press release.
Naloxone is a medication that can rapidly reverse the effects of an opioid overdose and is the standard treatment for such overdoses.
Now, thanks to the approval from the FDA, the overdose medication will be available at drug stores, convenience stores, grocery stores, gas stations, and more.
The FDA shared that it is still working with stakeholders to “facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status.”
This is something the agency said could take months, though Califf is calling on manufacturers to work quickly and price the drug fairly.
“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,” Califf said.
Since 2015, naloxone has helped fight the growing drug issue in America. The medication has been distributed to pharmacies and also given to first responders, who have been quick to use the substance when responding to overdose calls.
Last November, the overdose medication was even used to save the life of a puppy overdosing on fentanyl. The Coldwater Fire Department shared in a Facebook post that a puppy named Whip was given two doses of the drug, which thankfully saved its life.
From October 2021 to October 2022, there were more than 100,000 fatal overdoses, with the FDA highlighting that the number was primarily “driven by synthetic opioids” like fentanyl.
The American Medical Association has shared that from 2016 to 2021, nearly nine times the amount of naloxone doses have been dispensed by retail pharmacies, with 2021 seeing 1.2 million doses given out.
As opioid usage continues to grow, both knowingly and unknowingly, the use of naloxone is expected to grow with it.
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