Federal regulators approved the first over-the-counter naloxone product Wednesday, enabling people to buy the opioid overdose treatment directly from places like pharmacies, convenience stores and online.
The U.S. Food and Drug Administration approved the nasal spray naloxone product, commonly known as Narcan, for use without a prescription. Narcan has been approved as a prescription drug since 2015 and is the standard treatment to reverse an opioid overdose by reversing or blocking an opioid’s effects on the brain.
More than 101,000 fatal overdoses were reported nationwide between November 2021 and October 2022, driven mostly by opioids like fentanyl.
“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” said Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research. “The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status.”
A timeline for when Narcan could be available without a prescription and how much it will cost are still to be determined by the manufacturer that received Wednesday’s authorization, the biopharmaceutical company Emergent BioSolutions Inc.
However, according to the FDA, the regulatory process to change naloxone from being solely available as a prescription drug to being available both with and without a prescription could take months and will require a change in labeling for currently approved 4 milligram naloxone nasal sprays.
Other Narcan manufacturers beyond Emergent BioSolutions will also be required to update their existing authorizations to make their products available as over-the-counter drugs.
“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,” FDA Commissioner Dr. Robert Califf said. “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.”
Almost as good as closing the border..
How typical of DEMs, attempt to mitigate effects rather than going after the cause and holding criminals accountable with long and stiff prison time.
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‘Bill to Hold Drug Dealers Accountable for Fentanyl Deaths Fails in Committee’
https://tinyurl.com/4u6ba6wp
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If there is no threat of incarceration,
there is no deterrence to criminal behavior
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So who exactly are members of CA state legislature looking out for ? ? ?
Big pharma will price this stuff like the Epi-pen.
Cheap at first then outrageously expensive.
Another big win for pharma and the sold-out politicians/bureaucrats who’ll get some nice kickback for this.
It brought my (then) heroin addicted son back to life 2 different times! He lives in northern Oregon since 2020. Some of his Drug Attic buddies (Bums) got it into him and revived him in 2 separate incidents. HOWEVER: …..
Has been clean and sober for about 2 and a half years now after a fantastic experience with Life Line (a great recovery program in WA and lived in a “sober living” house for over 1 year! They put him to work in their treatment center as a janitor for 6 months, and then helped him get a great job as a “sanitizer” in the huge Frito-Lay factory in Vancouver WA. He works 40 to 50 hours per week making $24 an hour plus overtime pay!
We are really proud of him, and he calls us 2 or 3 times a week to “check in”, and sees his mother (my X) regularly in Portland’s suburbs. There are some “good stories” out there, and he is one of them.
Thank you for sharing your story – blessings to you and your family, and Godspeed In your son’s progress and healing.
Glad it worked out for your family. My kids had a friend who went up north for the drug scene and he will never be coming home. Was great kid before drugs.
It’s great to hear about your son. I wish him nothing but the best. Addiction appears to be increasing in our country so I’m happy to hear there are programs out there which can help those in need.
Since Home Land Security Secretary Mayorkas, President Biden, and of course the person in charge of the border herself Vice President Harris will do NOTHING to stop the flow of drugs into this country, I’m glad to see at least one agency trying to save American lives.
will one who administers be covered under the good samaritan act?
Good question!
everyone should be able to get Narcan. This is gone beyond our control “Thank you sh!t heads in Washington” and we need to be able to take care of the ones that made a mistake. I get it that addicts use it like methadone and it is a fall back for overdoing it but some of our friends “and children” that get caught up in stupid we do not need to lose.