Health
FDA approves Narcan to reverse overdose for over-the-counter use
March 29, 2023 – The FDA has approved Narcan, a drug that helps reduce opioid overdose, for over-the-counter use, the FDA announced Wednesday morning.
The nasal spray uses naloxone hydrochloride and is available online, at drug stores, grocery stores, and gas stations. It became available by prescription in 2016.
Opioid overdoses kill more than 100,000 people in the United States each year, most of which are synthetic opioids such as fentanyl. FDA Commissioner Robert M. Califf, MD, said making Narcan more readily available would address a “serious public health need.”
But it’s unclear how much the nasal spray will cost, or whether pharmacies will openly put the product on shelves. Major pharmacy chains such as CVS and Walgreens now make naloxone available without a prescription, but consumers must ask a pharmacist to dispense it.
“The main question is how much it will cost,” he said. Brian Hurley, M.D. President-elect of the American Society of Addiction Medicine. “For people to have access to it, they have to be able to afford it.”
“If people can’t afford to buy Narkan, we won’t get much done. National Council for Mental Health President and CEO Chuck Ingolia said in a statement. However, he said, “While no single approach can eliminate overdose deaths, making Narcan readily available and widely available could save countless lives each year.” There is.”
“[The] The FDA’s decision will change the way we respond compassionately and rationally to the overdose epidemic,” said Bobby Mukkamara, M.D., chair of the American Medical Association’s Substance Use and Pain Management Task Force. said. in a statement“More lives could be saved if naloxone was readily available in grocery stores and pharmacies,” he said.
However, “for this change to be most effective, manufacturers need to make naloxone more affordable, which is important for community organizations working to make naloxone available.” is an element.
in the statementthe FDA said the timeline for the drug’s price and its availability would be “determined by the manufacturer.”
“We encourage manufacturers to prioritize accessibility to their products by making them available as quickly and affordably as possible,” Califf said.
Emergent BioSolutions did not comment on costs.said in a statement The spray “will be available on U.S. shelves and online retailers by the end of the summer,” he said, adapting Narcan for direct-to-consumer use, including more consumer-friendly packaging.
The cost of naloxone varies depending on geographic location and whether it is generic. According to GoodRX, a box of two doses of generic naloxone costs between $31 and $100, depending on location and coupon availability. A two-dose box of Narcan is priced at $135-$140.urgent report 14% decrease Naloxone sales will be $373.7 million in 2022, due in part to the introduction of generics.
Hurley anticipates that people who buy Narcan at drugstores are primarily those who have already shopped at drugstores. It may or may not be people who experience an overdose.
Making Narcan available over-the-counter “is an important complement, but not a replacement for the existing naloxone line of distribution programs,” Hurley said.
The FDA has been encouraging naloxone manufacturers to seek OTC approval since at least 2019, when it designed model labels for theoretical OTC products. In November, the agency it had decided Some naloxone products may be safe and effective for over-the-counter use, prompting the pharmaceutical companies again to seek such approval.
Emergent BioSolutions was the first to receive OTC approval, but another manufacturer, a non-profit harm reduction treatment, The company is awaiting approval of its application to market the spray directly to consumers. In December, Harm Reduction Therapeutics said its nasal spray application was being processed expeditiously by the FDA and, if approved, the product would retail for $18.
Mukkamala said the AMA is urging all manufacturers to seek OTC approval and is asking them to work with retailers to make their products stand out on store shelves. Health insurers “must continue or start covering naloxone for free or at low cost,” he said, the AMA.
Dr. Scott Gottlieb, FDA Commissioner from 2017 to 2019, said: in a tweet A lot more work was needed.
“Following this regulatory move, there must be a strong push by elected officials to support wider deployment of Narkan and deliver more doses to at-risk homes and frontline workers. he tweeted.
By making Narkan readily available, you’re more likely to have it on hand in an emergency. This drug can restore slowed or stopped breathing in people who have overdosed on opioids.of published instructions If you use Narcan, tell them to take the following steps to identify an opioid overdose first, then use the drug.
- Ask the person if they are okay and shout out the person’s name. Shake his shoulder and rub him firmly in the middle of his chest.
- Check for signs of opioid overdose. For example, the person does not wake up or respond to your touch or voice. Very slow, irregular, or stopped breathing. Their pupils look like pinpoints.
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