{"id":37906,"date":"2025-01-31T03:19:54","date_gmt":"2025-01-31T09:19:54","guid":{"rendered":"https:\/\/ustower.net\/?p=37906"},"modified":"2025-01-31T03:20:21","modified_gmt":"2025-01-31T09:20:21","slug":"fda-approves-new-type-of-nonopioid-painkiller-for-acute-pain","status":"publish","type":"post","link":"https:\/\/ustower.net\/?p=37906","title":{"rendered":"FDA approves new type of nonopioid painkiller for acute pain"},"content":{"rendered":"\n

The Food and Drug Administration on Thursday approved a new type of nonopioid painkiller<\/a> from Vertex Pharmaceuticals.<\/p>\n\n\n\n

The drug, Journavx, or suzetrigine, was approved to treat moderate to severe acute, or short-term, pain in adults. Experts say the drug, which is billed as nonaddictive, could reduce the number of opioids patients are prescribed<\/a> after surgery or be used by patients who can\u2019t take other pain medications \u2014 though several told NBC News they would like to see more research.<\/p>\n\n\n\n

In a statement, Dr. Jacqueline Corrigan-Curay, the acting director of the FDA’s Center for Drug Evaluation and Research, called the approval \u201can important public health milestone in acute pain management.\u201d<\/p>\n\n\n\n

Michael Schatman, a clinical instructor in the department of anesthesiology, perioperative care and pain medicine at NYU Grossman School of Medicine, said: \u201cI think in acute pain this drug has great promise. This is something that could be opioid-sparing, and we need more tools in our armory for pain.\u201d<\/p>\n\n\n\n

Although the number of patients going home from surgery with opioids has declined<\/a> in recent years, many patients still leave the hospital with prescriptions. Despite the risks<\/a>, opioids are extremely effective at treating pain, which has left doctors and patients with few options when acetaminophen (Tylenol) and nonsteroidal anti-inflammatory drugs, such as ibuprofen, aren\u2019t enough.<\/p>\n\n\n\n

\u201cWe know from CDC data that anyone who gets exposed to opioids has the potential to have dependence on them,\u201d said Dr. Richard Rosenquist, enterprise chairman in the department of pain management in the Neurological Institute at the Cleveland Clinic. <\/p>\n\n\n\n

The body registers pain through nerve endings throughout the body. Touch a hot stove, for example, and the nerve will send signals to the spinal cord and up to the brain that you\u2019re experiencing pain in your hand. <\/p>\n\n\n\n

Opioids work by stimulating opioid receptors in the brain, blocking those pain signals. During the process, the brain also floods with the neurotransmitter dopamine, creating feelings of euphoria and activating the brain\u2019s reward system. That\u2019s why opioids can be incredibly addictive<\/a>.  <\/p>\n\n\n\n

Vertex\u2019s drug works in a completely different way, by blocking the pain signal from traveling to the brain in the first place. The signal is triggered by sodium molecules rushing into the nerve ending, sending the message onward to the brain. <\/p>\n\n\n\n

Suzetrigine is a sodium channel blocker, the same type of drug as lidocaine. Lidocaine, a local anesthetic, works by blocking all sodium channels in the area it\u2019s applied to \u2014 for example, the gums during dental work. A sodium channel blocker taken as a pill, such as suzetrigine, must be much more precise, as sodium channels are found throughout the body and are critical for heart and brain function. Suzetrigine blocks nerve pulses from just one sodium channel, called NaV1.8, from reaching the brain and being interpreted as pain. <\/p>\n\n\n\n

\u201cThis is the first time we have had something that targets a specific sodium channel,\u201d said Rosenquist, who wasn’t involved with the research on the drug. <\/p>\n\n\n\n

The process also doesn\u2019t stimulate opioid receptors or produce any feelings of euphoria, he said.<\/p>\n\n\n\n

\u201cRight now all the evidence suggests this has no addiction potential at all,\u201d Rosenquist said. \u201cIt\u2019s no different than Tylenol or ibuprofen in terms of addiction potential.\u201d<\/p>\n\n\n\n

Tummy tucks and bunion surgery<\/strong><\/strong><\/h2>\n\n\n\n

In phase 3 clinical trials by the drugmaker, researchers looked at how well the drug worked after surgery. Patients who had undergone either tummy tucks or bunion surgery were given either suzetrigine every 12 hours; an opioid, hydrocodone, plus Tylenol every six hours; or a placebo for 48 hours after the operations. <\/p>\n\n\n\n

Some of the patients who got suzetrigine also took ibuprofen as a so-called rescue medication \u2014 that is, if they were still experiencing pain after their suzetrigine doses. <\/p>\n\n\n\n

\u201cThe results we have now do not tell us a lot about how much of a rescue medication was used,\u201d said Dr. David Rind, chief medical officer at the Institute for Clinical and Economic Review (ICER), a nonprofit group that evaluates the cost, safety and efficacy of drugs. \u201cWe don\u2019t know if they would have had higher pain reduction if they had just taken an NSAID from the start.\u201d<\/p>\n\n\n\n

Both tummy tuck and bunion surgery patients who got suzetrigine reported about a 50% reduction in their pain after 48 hours, similar to the reduction in pain reported by patients who got the opioid plus Tylenol. <\/p>\n\n\n\n

About 50% of people in the tummy tuck group and about 30% in the bunion surgery group reported some kind of side effect, most commonly headache, constipation or nausea, but, except for constipation, the side effects were less common in patients who got suzetrigine compared with an opioid.<\/p>\n\n\n\n

The dose of hydrocodone was also smaller than what is typically given after surgery, \u201cso it\u2019s hard to know exactly what to make of the results,\u201d Rind said. <\/p>\n\n\n\n

In another phase 3 study, patients taking suzetrigine for either surgery or acute pain rated how well they thought it worked. Participants took it every 12 hours for 14 days or until their pain subsided. In that study, 82% of surgical patients and 91% of nonsurgical patients said suzetrigine was good, very good or excellent at treating their pain. About 37% experienced some kind of adverse event, but most were mild, including headache, constipation, nausea, falling or having rashes. <\/p>\n\n\n\n

Dr. Todd Bertoch, chief medical officer for pain research at CenExel JBR Clinical Research in Salt Lake City, led the phase 3 trials for suzetrigine in people who had undergone either tummy tucks or or bunion surgery.<\/p>\n\n\n\n

While the clinical trial showed the drug could be effective as a solo treatment for pain \u2014 though it was more effective when patients combined it with ibuprofen \u2014 suzetrigine is meant to be used as part of a step-up approach, after Tylenol and NSAIDs, Bertoch said. <\/p>\n\n\n\n

\u201cIf I still have pain after that, I\u2019m kind of stuck. My next step is an opioid,\u201d he said. \u201cThe goal is to make the next step not an opioid, and that\u2019s what suzetrigine does.\u201d <\/p>\n\n\n\n

Suzetrigine could also be used in patients for whom Tylenol or NSAIDs aren\u2019t safe, such as those with kidney or liver disease<\/a>, he added. <\/p>\n\n\n\n

Questions remain, but doctors see promise<\/strong><\/strong><\/h2>\n\n\n\n

In a report last month<\/a> by ICER, a panel of experts rated the current data on suzetrigine as \u201cpromising but inconclusive.\u201d By the group\u2019s definition, that means it is moderately certain the drug would provide a small or substantial benefit to patients and a small \u2014 but not zero \u2014 chance of negative health consequences. <\/p>\n\n\n\n

How much potential risk of harm is tolerable depends on the type of drug it is, Rind said. For example, it\u2019s widely accepted that cancer drugs have harsh side effects but not enough to outweigh the potential benefit of treating an often fatal disease. <\/p>\n\n\n\n

In those situations, \u201cyou are willing to accept a higher risk,\u201d Rind said. \u201cWith a new pain reliever, it really has to be incredibly safe to be OK, and we really will not know that until it\u2019s on the market and used by lots of people.\u201d<\/p>\n\n\n\n

New drugs like suzetrigine should be tried first in people who can\u2019t take other pain medications, he said. For example, someone who has a history of both gastrointestinal bleeding, which makes taking NSAIDs dangerous, and addiction, which would deter a doctor from prescribing opioids<\/a>, would be a good candidate for suzetrigine. <\/p>\n\n\n\n

\u201cThere are a lot of people like that. It\u2019s not like that is a tiny segment of the population,\u201d Rind said. <\/p>\n\n\n\n

Despite remaining questions about the drug\u2019s efficacy and long-term safety, Rind said the physicians he has spoken with are excited about the drug.<\/p>\n\n\n\n

\u201cWe have heard from pretty much every pain expert we talked to about how excited they are to have a new class of pain drugs in a space where there hasn\u2019t been a new class of drugs in a very long time,\u201d he said.<\/p>\n\n\n\n

Schatman, of NYU Grossman School of Medicine, said suzetrigine does seem safe and effective for short-term use; however, he voiced concerns that Vertex doesn\u2019t have longer-term safety data. (Schatman is the senior medical adviser for Apurano Pharma, a German biotech company, and he is working on a similar drug for chronic pain.) <\/p>\n\n\n\n

\u201cThere is relatively strong safety data for short-term use, and that is what the FDA requires,\u201d he said, but there is no set definition for how long acute pain lasts. Vertex isn\u2019t pursuing the FDA\u2019s approval for suzetrigine to treat chronic pain \u2014 a phase 2 clinical trial looking at suzetrigine<\/a> for sciatica found that it performed no better than a placebo at reducing pain after 12 weeks \u2014 but it is common for doctors to prescribe acute pain medications off-label for chronic pain. That, he said, is worrying. <\/p>\n\n\n\n

\u201cMy biggest concern is that we have drugs that are demonstrating as effective for acute pain that all of a sudden extrapolate the data to chronic pain,\u201d he said.  <\/p>\n\n\n\n

Because suzetrigine blocks pain signals in the peripheral nervous system \u2014 the nerves that carry signals to the central nervous system \u2014 the drug most likely won\u2019t work for\u2002chronic pain<\/a>, which is usually based in the central nervous system, said Dr. Holly Geyer, a hospital internal medicine practitioner at the Mayo Clinic in Rochester, Minnesota.<\/p>\n\n\n\n

Rosenquist said that even if further studies show suzetrigine doesn\u2019t block acute pain better than opioids, he believes it is still likely to have a place in pain management. <\/p>\n\n\n\n

\u201cYou have this tool that you can give to people in instances where they are discharged, they are in that recovery process, we are asking them to do rehab or walking or stuff like that, and would have gone home with an opioid,\u201d he said. \u201cThe step-up approach is a reasonable way to approach this. It could play a role in reducing the overall exposure to opioids.\u201d<\/p>\n\n\n\n

Whether doctors reach for the drug will most likely depend on its cost, Schatman and Rosenquist said. Rind, of ICER, said it is likely to depend on both how Vertex prices the new drug and in what contexts, if any, private insurers cover it.<\/p>\n\n\n\n

\u201cThe bottom line is NSAIDs, generic opioids and acetaminophen are cheap,\u201d Schatman said, adding that he hopes suzetrigine is priced in a way that allows patients to access it.<\/p>\n\n\n\n

Nbcnews<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

The Food and Drug Administration on Thursday approved a new type of nonopioid painkiller from Vertex Pharmaceuticals. The drug, Journavx, or suzetrigine, was approved to treat moderate to severe acute, or short-term, pain in adults. Experts say the drug, which is billed as nonaddictive, could reduce the number of opioids patients are prescribed after surgery or be used by […]<\/p>\n","protected":false},"author":5,"featured_media":37907,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5784],"tags":[8606,3043,32193,31886,32192],"class_list":["post-37906","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health","tag-approved","tag-fda","tag-non-opioid","tag-novel","tag-pain-reliever"],"_links":{"self":[{"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/posts\/37906","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=37906"}],"version-history":[{"count":1,"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/posts\/37906\/revisions"}],"predecessor-version":[{"id":37908,"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/posts\/37906\/revisions\/37908"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/media\/37907"}],"wp:attachment":[{"href":"https:\/\/ustower.net\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=37906"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=37906"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=37906"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}