{"id":2401,"date":"2023-03-31T13:08:08","date_gmt":"2023-03-31T18:08:08","guid":{"rendered":"https:\/\/nakedpolitics.net\/?p=2401"},"modified":"2023-03-31T13:08:08","modified_gmt":"2023-03-31T18:08:08","slug":"fda-approves-over-the-counter-drug-for-drug-addicts","status":"publish","type":"post","link":"https:\/\/nakedpolitics.net\/?p=2401","title":{"rendered":"FDA Approves Over-The-Counter Drug For Drug Addicts"},"content":{"rendered":"\n

The U.S. Food and Drug Administration on Wednesday approved selling naloxone<\/a> without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter.<\/p>\n\n\n\n

It\u2019s a move that some advocates have long sought as a way to improve access to a lifesaving drug, though the exact impact will not be clear immediately.<\/p>\n\n\n\n

Here\u2019s a look at the issues involved.<\/p>\n\n\n\n

What is Narcan?<\/h2>\n\n\n\n

The approved branded nasal spray from Gaithersburg, Md.-based Emergent BioSolutions is the best-known form of naloxone.<\/p>\n\n\n\n

It can reverse overdoses of opioids, including street drugs such as heroin and fentanyl and prescription versions including oxycodone.<\/p>\n\n\n\n

Making naloxone available more widely is seen as a key strategy to control the nationwide overdose crisis, which has been linked to more than 100,000 U.S. deaths a year<\/a>. The majority of those deaths are tied to opioids, primarily potent synthetic versions such as fentanyl that can take multiple doses of naloxone to reverse.<\/p>\n\n\n\n

Advocates believe it\u2019s important to get naloxone to the people who are most likely to be around overdoses, including people who use drugs and their relatives.<\/p>\n\n\n\n

Police and other first responders also often carry it.<\/p>\n\n\n\n

What does the FDA approval mean?<\/h2>\n\n\n\n

Narcan will become available over-the-counter by late summer, the company said.<\/p>\n\n\n\n

Other brands of naloxone and injectable forms will not yet be available over the counter, but they could be soon.<\/p>\n\n\n\n

The nonprofit Harm Reduction Therapeutics Inc., which has funding from OxyContin maker Purdue Pharma, has an application before the FDA to distribute its version of spray naloxone without a prescription.<\/p>\n\n\n\n

How is naloxone distributed now?<\/h2>\n\n\n\n

Even before the FDA\u2019s action, pharmacies could sell naloxone without a prescription because officials in every state have allowed it.<\/p>\n\n\n\n

But not every pharmacy carries it. And buyers have to pay for the medication \u2014 either with an insurance copay or for the full retail price. The cost varies, but two doses of Narcan often go for around $50.<\/p>\n\n\n\n

The drug is also distributed by community organizations that serve people who use drugs, though it\u2019s not easily accessible<\/a> to everyone who needs it.<\/p>\n\n\n\n

Emergent has not announced its price and it\u2019s not clear yet whether insurers will continue to cover it as a prescription drug if it\u2019s available over the counter.<\/p>\n\n\n\n

Does making naloxone over-the-counter improve access?<\/h2>\n\n\n\n

It clears the way for Narcan to be made available in places without pharmacies \u2014 convenience stores, supermarkets, and online retailers, for instance.<\/p>\n\n\n\n

Jose Benitez, the lead executive officer at Prevention Point Philadelphia, an organization that tries to reduce risk for people who use drugs with services including handing out free naloxone, said it could help a lot for people who don\u2019t seek services \u2014 or who live in places where they\u2019re not available.<\/p>\n\n\n\n

Now, he said, some people are concerned about getting naloxone at pharmacies because their insurers will know they\u2019re getting it.<\/p>\n\n\n\n

\u201cPutting it out of the shelves is going to allows people just to pick it up, not have stigma attached to it and readily access this lifesaving drug,\u201d he said.<\/p>\n\n\n\n

But it remains to be seen how many stores will carry it and what the prices will be. The U.S. Centers for Medicaid and Medicare Services, which now cover prescription naloxone for people on the government insurance programs, says that coverage of over-the-counter naloxone would depend on the insurance program. The centers have not given any official guidance.<\/p>\n\n\n\n

Maya Doe-Simkins, a co-director of Remedy Alliance\/For The People, which launched last year to provide low-cost \u2014 and sometimes free \u2014 naloxone to community organizations, said her group will continue to distribute injectable naloxone.<\/p>\n\n\n\n

Are there drawbacks to over-the-counter sales?<\/h2>\n\n\n\n

One concern is whether people who buy Narcan over-the-counter will know how to use it properly, said Keith Humphreys, a Stanford University addiction expert, though the manufacturer is responsible for clear directions and online videos on that.<\/p>\n\n\n\n

One benefit of having pharmacists involved, he said, is that they can show buyers how to use it. One key thing people need to be reminded of: Call an ambulance for the person receiving naloxone after it\u2019s been administered.<\/p>\n\n\n\n

He also said there are fears that if the drug isn\u2019t profitable as an over-the-counter option, the drugmaker could stop producing it.<\/p>\n\n\n\n

Original Article: https:\/\/www.statnews.com\/2023\/03\/29\/narcan-fda-approval-over-the-counter\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

The U.S. Food and Drug Administration on Wednesday approved selling naloxone without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter. It\u2019s a move that some advocates have long sought as a way to improve access to a lifesaving drug, though the exact impact will not be clear immediately. Here\u2019s a look at the issues involved. What is Narcan? The approved branded nasal spray from Gaithersburg, Md.-based Emergent BioSolutions is the best-known […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-2401","post","type-post","status-publish","format-standard","hentry","category-crime"],"jetpack_sharing_enabled":true,"jetpack_featured_media_url":"","_links":{"self":[{"href":"https:\/\/nakedpolitics.net\/index.php?rest_route=\/wp\/v2\/posts\/2401","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nakedpolitics.net\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nakedpolitics.net\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nakedpolitics.net\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/nakedpolitics.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2401"}],"version-history":[{"count":1,"href":"https:\/\/nakedpolitics.net\/index.php?rest_route=\/wp\/v2\/posts\/2401\/revisions"}],"predecessor-version":[{"id":2402,"href":"https:\/\/nakedpolitics.net\/index.php?rest_route=\/wp\/v2\/posts\/2401\/revisions\/2402"}],"wp:attachment":[{"href":"https:\/\/nakedpolitics.net\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2401"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nakedpolitics.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2401"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nakedpolitics.net\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2401"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}