On Jan. 30, the U.S. Meals and Drug Administration (FDA) accepted a brand new drug referred to as suzetrigine to deal with moderate-to-severe ache. The prescription tablets, offered below the model identify Journavx and made by Vertex Prescription drugs, are taken twice a day and symbolize the primary new class of ache drugs in 20 years—and the primary non-opioid painkiller since that class first appeared available on the market within the Eighties.
Whereas opioids are presently essentially the most potent and efficient technique to management ache, they’re related to a big threat of habit, and have fueled an epidemic of habit and overdose deaths within the U.S. in latest a long time. From 1999 to 2017, deaths from overdose as a result of prescription opioids elevated greater than seven instances, exposing a dire want for efficient however nonaddictive methods to handle ache.
Here is what to find out about suzetrigine.
How suzetrigine works
One main conduit for ache transmission within the human physique is thru sodium channels. Folks have 9 such sodium channels within the physique, and completely different ones are lively in several tissue sorts, together with within the mind.
Suzetrigine relieves ache by controlling the movement of sodium out and in of cells, and it targets one sodium channel that’s particular to ache neurons in tissues which are discovered all through the physique however not within the mind. The remedy due to this fact avoids the addictive potential of opioids, which work by binding to opioid receptors all through the central nervous system, in each the mind and spinal wire.
Discovering the suitable sodium channel goal, nevertheless, took a long time of analysis, which was all of the more difficult since sodium channels by definition work rapidly—so their results, and the results of any compounds designed to regulate them, are exhausting to measure. As soon as researchers recognized the particular sodium channel that was selectively lively in ache nerves, referred to as Nav 1.8, scientists at Vertex combed by way of libraries of compounds to search out an efficient inhibitor to dam the opening of the channel. “We screened a whole bunch of 1000’s of compounds searching for the needle within the haystack that inhibited 1.8,” says Paul Negulescu, senior vice chairman at Vertex. Animal research had been encouraging, and the corporate launched human research that had been accomplished in early 2024. Vertex submitted a request for FDA approval in July.
What the research discovered
Trials included individuals with acute ache after two kinds of surgical procedure—bunion elimination and tummy tucks—that represented two main kinds of pain-generating damage: to bone and gentle tissues, respectively. Researchers tracked individuals’s self-reported measures of ache for 48 hours, starting instantly after their anesthesia wore off. Folks had been randomly assigned to obtain suzetrigine, hydrocodone-acetaminophen (an opioid), or a placebo to deal with their ache.
These receiving suzetrigine reported round a higher and sooner discount in ache in comparison with these taking placebo tablets; amongst these getting abdominoplasty, 61% of these taking suzetrigine reported a minimum of a 30% drop in ache, which researchers think about significant, in comparison with 48% taking placebo. Amongst these getting bunionectomy, 83% these taking suzetrigine achieved this threshold, in comparison with 68% of these getting placebo.
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Folks assigned to the opioid hydrocodone and acetaminophen group reported higher ache management than these taking suzetrigine, however suzetrigine would not carry the danger of habit. “We noticed sufferers reporting large decreases in ache,” says Dr. Jessica McCoun, an anesthesiologist who was one of many principal investigators on trials for each bunionectomy and abdominoplasty at CenExel in Atlanta, one of many trial websites. The outcomes “make me consider that suzetrigine might exchange opioid use, though I can’t say that for certain,” she says. “Any novel class of drug is a large alternative, since we haven’t had something new within the ache area in 20 years.”
The corporate additionally carried out a 3rd examine of individuals with a wider vary of pain-related situations—each surgical and non-surgical—affecting the pinnacle, neck, shoulder, knee, foot, and ankle. On this examine, sufferers knew they had been receiving the drug. These outcomes additionally confirmed that suzetrigine successfully relieved ache in quite a lot of situations.
Might it work for continual ache?
Vertex can also be exploring whether or not suzetrigine might handle continual ache, which normally stems from a extra complicated and sprawling set of situations than acute ache. These outcomes have been much less stable to date. Amongst sufferers with sciatica, those that acquired suzetrigine and those that acquired a placebo reported equally small reductions in ache after 12 weeks.
Nonetheless, Negulescu says the corporate is shifting forward with later-stage testing to raised regulate for the placebo impact and higher perceive the drug’s impact in continual ache. “Our perception is that the Nav1.8 mechanism goes to be related in each acute and continual ache,” he says.
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Power ache will be traced to 2 major mechanisms, Negulescu says. One impacts muscle tissue and bone—in arthritis and low again ache, for instance—during which nerves stay intact, however tissues surrounding them are broken and begin sending ache alerts. One other kind of continual ache happens when the nerves themselves are broken, which happens in situations like diabetes, particularly in peripheral tissues like fingers and ft. “We consider the mechanism of suzetrigine is related in each musculoskeletal and neuropathic ache,” says Negulescu. “Our working speculation, based mostly on the info we’ve, is that Nav1.8 remains to be expressed and current in continual situations.”
How the approval might change ache administration
As efficient as suzetrigine is, it doesn’t fully eradicate it. “Sufferers nonetheless really feel ache; they don’t go to zero ache sensation,” says Negulescu. However, he believes, suzetrigine reveals that it could be attainable to get higher at exactly controlling the sodium-channel ache sign to realize higher ache administration. “We’re getting into a brand new period the place we might be able to extra safely and particularly inhibit ache, and that may change our relationship to and the way we take into consideration ache,” he says.
Dr. Todd Bertoch, chief medical officer for ache analysis at CenExel in Utah, who was the lead investigator on the suzetrigine research, additionally notes that the tablets had been related to comparatively few negative effects—a serious distinguisher from opioids. “That is the primary examine I’ve ever carried out the place the side-effect profile for individuals on placebo was worse than the side-effect profile for individuals on the examine drug,” he says.
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The place suzetrigine will match into the pain-management panorama stays to be seen, however specialists see its potential in treating extra severe ache, if over-the-counter treatments don’t work. Ideally, ache specialists consider it might be the first-line remedy after surgical procedures and minor procedures, together with dental procedures, as an alternative of the opioids which are presently prescribed.
Bertoch says opioids could proceed to have a spot in treating sure sorts of ache, however suzetrigine offers docs an alternative choice. “Suzetrigine lets me add one other instrument that doesn’t have liver toxicity, doesn’t have kidney toxicity, could be very secure, and is a minimum of additive and possibly even synergistic with acetaminophen and ibuprofen,” he says. “It fills a niche the place in any other case we’ve used opioids.”
