{"id":3052,"date":"2025-01-31T00:36:38","date_gmt":"2025-01-31T00:36:38","guid":{"rendered":"https:\/\/site.itshrt.com\/worldnews\/fda-approves-journavx-drug-to-treat-pain-without-addiction-risk\/"},"modified":"2025-01-31T00:36:38","modified_gmt":"2025-01-31T00:36:38","slug":"fda-approves-journavx-drug-to-treat-pain-without-addiction-risk","status":"publish","type":"post","link":"https:\/\/site.itshrt.com\/worldnews\/fda-approves-journavx-drug-to-treat-pain-without-addiction-risk\/","title":{"rendered":"FDA Approves Journavx Drug to Treat Pain Without Addiction Risk"},"content":{"rendered":"<p> <script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-6606220950177433\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- ItShrt World News -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-6606220950177433\"\r\n     data-ad-slot=\"1882483372\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<br \/>\n<\/p>\n<div data-testid=\"companionColumn-0\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">The Food and Drug Administration approved a new medication Thursday to treat pain from an injury or surgery. It is expensive, with a list price of $15.50 per pill. But unlike opioid pain medicines, it cannot become addictive.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">That is because the drug, suzetrigine, made by Vertex Pharmaceuticals and to be sold as Journavx, works only on nerves outside the brain, blocking pain signals. It cannot get into the brain.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Researchers say they expect it to be the first of a new generation of more powerful nonaddictive drugs to relieve pain.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">To test the drug, Vertex, which is based in Boston, conducted <a class=\"css-yywogo\" href=\"https:\/\/investors.vrtx.com\/static-files\/39514f75-f903-4a34-a729-7b1646b4b0f9\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">two large clinical trials<\/a>, each with approximately 1,000 patients who had pain from surgery. They were randomly assigned to get a placebo; to get the opioid sold as Vicodin, a widely used combination pain medicine of acetaminophen (Tylenol) and hydrocodone; or to get suzetrigine.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-1\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">In one trial, patients had an abdominoplasty, or tummy tuck. In the other, they had a bunionectomy. Side effects of suzetrigine reported by patients were similar to the ones reported by those taking the placebo.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The company also submitted data from a 250-person study that assessed the drug\u2019s safety and tolerability in patients with pain from surgery, trauma or accidents.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Suzetrigine eased pain as much as the combination opioid. Both were better than the placebo at relieving pain.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-2\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">Suzetrigine\u2019s price, though, is much higher than that of acetaminophen plus hydrocodone. Patients are expected to take two pills a day, for a total cost of $31 a day. The older drug, said Dr. John D. Loeser, an emeritus pain expert at the University of Washington, is \u201cdirt cheap\u201d at pennies per pill.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-3\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">But suzetrigine does not have opioids\u2019 unpleasant side effects like nausea and drowsiness, and it is nonaddictive.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cThere are a number of people who, once they have an opioid, want an opioid constantly,\u201d Dr. Loeser said.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">About 85,000 people a year become addicted after taking a prescription opioid, said Dr. David Altshuler, chief scientific officer at Vertex. It\u2019s a small proportion of the 40 million prescribed opioids each year for acute pain \u2014 from surgery, accidents or trauma \u2014 but is nonetheless a large number, he said.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The story of suzetrigine began in the late 1990s with basic <a class=\"css-yywogo\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/9133375\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">research<\/a> by Dr. Stephen Waxman of Yale. He wondered how nerve cells signal pain to the brain.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Nerve cells have nine sodium channels \u2014 tiny molecular batteries \u2014 that generate electrical signals.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-4\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">But, he discovered, two of those channels are only active outside the brain. One, called <a class=\"css-yywogo\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/9822722\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">Nav1.7, is like the fuse<\/a> for a firecracker, Dr. Waxman said. A nerve cell activates Nav1.7. That signal, in turn, activates a <a class=\"css-yywogo\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/11495938\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">second channel, Nav1.8<\/a>, which, he said, sends electrical signals of pain to the brain.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">It seemed that a drug that could block Nav1.7 or Nav1.8 could be a potent pain medication that would have no effects on the brain, and therefore would not be addictive. (Dr. Waxman is not paid by Vertex, but does consult for other companies working on similar drugs.)<\/p>\n<p class=\"css-at9mc1 evys1bk0\">But there was another piece of the puzzle: Were these lab results applicable to humans?<\/p>\n<p class=\"css-at9mc1 evys1bk0\">If the lab work was predictive, people with mutations that made Nav1.7 or Nav1.8 fire constantly would be in constant pain. And people with the opposite mutation \u2014 one that blocked the channels \u2014 should feel no pain.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Both sorts of mutations would be extremely rare, if they existed.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Dr. Waxman contacted pain physicians across the entire Northern Hemisphere, asking if they had patients who had constant, intractable pain that could be caused by mutations that made Nav1.7 or Nav1.8 overactive. He came up empty-handed.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Then, in 2004, the Erythromelalgia Association told him about a family in Alabama whose members were wracked with pain. Most had ended up addicted to opioids and were unable to go to school or to work. Their condition was called \u201cMan on Fire syndrome.\u201d<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-5\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">Dr. Waxman and his colleagues found that the members of this family had a <a class=\"css-yywogo\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/15958509\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">mutation in the Nav1.7<\/a> channel that made their pain nerves fire constantly.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Another group of researchers reported that a family in Pakistan whose members <a class=\"css-yywogo\" href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/17167479\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">felt no pain<\/a> had a mutation that blocked the same channel from firing. People called them firewalkers because they could walk on hot coals and feel nothing, which they did for money.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Vertex\u2019s new drug, which blocks the Nav1.8 channel, is highly specific \u2014 the other sodium channels are left alone by the drug. Suzetrigine\u2019s effects disappear when people stop taking the pills.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">But although people with acute pain might need such a drug, there is also another group that needs pain relief but has few good options \u2014 those who have damaged nerves that cause constant pain, called peripheral neuropathic pain. That group includes people with diabetes, which can make the hands or feet hurt or go numb, among other symptoms. And it includes people with lumbosacral radiculopathy, or pinched nerves in the spine. Sciatica is one form of this condition.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">In small studies, Vertex found that suzetrigine helped those with diabetic neuropathy, but was no better than placebo in those with pinched spinal nerves.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-6\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">But, Dr. Altshuler said, the company is going ahead with larger studies in both groups of patients. While analysts and researchers deemed the results disappointing in patients with pinched nerves in their spines, the company decided to proceed because there are no approved drugs for the painful condition, and because the drug is safe and \u201cthe mechanism of action is so clearly validated.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cNo one has ever helped these four million people,\u201d he said.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<p><script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-6606220950177433\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- ItShrt World News -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-6606220950177433\"\r\n     data-ad-slot=\"1882483372\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<br \/>\n<br \/><a href=\"https:\/\/www.nytimes.com\/2025\/01\/30\/health\/fda-journavx-suzetrigine-vertex-opioids.html\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Food and Drug Administration approved a new medication Thursday to treat pain from an injury or surgery. It is<\/p>\n","protected":false},"author":1,"featured_media":3053,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[1269,1068,934,139,232,1268,931,219,268,1270],"class_list":["post-3052","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-2","tag-addiction-psychology","tag-brain","tag-clinical-trials","tag-drugs-pharmaceuticals","tag-food-and-drug-administration","tag-pain-relieving-drugs","tag-placebos","tag-regulation-and-deregulation-of-industry","tag-research","tag-vertex-pharmaceuticals-inc"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA Approves Journavx Drug to Treat Pain Without Addiction Risk - World News<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/site.itshrt.com\/worldnews\/fda-approves-journavx-drug-to-treat-pain-without-addiction-risk\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Approves Journavx Drug to Treat Pain Without Addiction Risk - World News\" \/>\n<meta property=\"og:description\" content=\"The Food and Drug Administration approved a new medication Thursday to treat pain from an injury or surgery. 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