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FDA Approves the First Non-Opioid Pain Medicine in 20 Years

On Jan. 30, the U.S. Meals and Drug Administration (FDA) approved a brand new drug referred to as suzetrigine to deal with moderate-to-severe ache. The prescription tablets, offered beneath the model title Journavx and made by Vertex Prescription drugs, are taken twice a day and signify the primary new class of ache medicines in 20 years—and the primary non-opioid painkiller since that class first appeared in the marketplace within the Nineteen Eighties.

Whereas opioids are at present essentially the most potent and efficient solution to management ache, they’re related to a big danger 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 attributable to prescription opioids elevated greater than seven instances, exposing a dire want for efficient however nonaddictive methods to handle ache.

This is what to learn 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 totally different ones are energetic in numerous tissue varieties, 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 treatment subsequently 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 twine.

Discovering the correct sodium channel goal, nevertheless, took a long time of analysis, which was all of the tougher since sodium channels by definition work rapidly—so their results, and the results of any compounds designed to manage them, are laborious to measure. As soon as researchers recognized the particular sodium channel that was selectively energetic in ache nerves, referred to as Nav 1.8, scientists at Vertex combed via libraries of compounds to seek 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 folks with acute ache after two varieties of surgical procedure—bunion removing and tummy tucks—that represented two main varieties of pain-generating harm: to bone and mushy tissues, respectively. Researchers tracked folks’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 quicker discount in ache in comparison with these taking placebo tablets; amongst these getting abdominoplasty, 61% of these taking suzetrigine reported at the least a 30% drop in ache, which researchers take into account 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 does not carry the danger of habit. “We noticed sufferers reporting big 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 imagine that suzetrigine might substitute opioid use, though I can’t say that for certain,” she says. “Any novel class of drug is a big alternative, since we haven’t had something new within the ache house in 20 years.”

The corporate additionally performed a 3rd research of individuals with a wider vary of pain-related situations—each surgical and non-surgical—affecting the top, neck, shoulder, knee, foot, and ankle. On this research, sufferers knew they had been receiving the drug. These outcomes additionally confirmed that suzetrigine successfully relieved ache in quite a lot of situations.

May it work for persistent ache?

Vertex can also be exploring whether or not suzetrigine might handle persistent ache, which normally stems from a extra advanced and sprawling set of situations than acute ache. These results have been much less stable up to now. Amongst sufferers with sciatica, those that obtained suzetrigine and those that obtained 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 persistent ache. “Our perception is that the Nav1.8 mechanism goes to be related in each acute and persistent ache,” he says.

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Power ache might be traced to 2 major mechanisms, Negulescu says. One impacts muscle mass and bone—in arthritis and low again ache, for instance—through which nerves stay intact, however tissues surrounding them are broken and begin sending ache indicators. One other kind of persistent ache happens when the nerves themselves are broken, which happens in situations like diabetes, particularly in peripheral tissues like fingers and ft. “We imagine the mechanism of suzetrigine is related in each musculoskeletal and neuropathic ache,” says Negulescu. “Our working speculation, based mostly on the information we’ve, is that Nav1.8 remains to be expressed and current in persistent situations.”

How the approval might change ache administration

As efficient as suzetrigine is, it doesn’t utterly remove it. “Sufferers nonetheless really feel ache; they don’t go to zero ache sensation,” says Negulescu. However, he believes, suzetrigine exhibits that it could be doable to get higher at exactly controlling the sodium-channel ache sign to realize higher ache administration. “We’re coming into a brand new period the place we could possibly extra safely and particularly inhibit ache, and that can 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 unintended effects—a significant distinguisher from opioids. “That is the primary research I’ve ever performed the place the side-effect profile for folks on placebo was worse than the side-effect profile for folks on the research drug,” he says.

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The place suzetrigine will match into the pain-management panorama stays to be seen, however consultants see its potential in treating extra severe ache, if over-the-counter treatments don’t work. Ideally, ache consultants imagine 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 at present prescribed.

Bertoch says opioids might proceed to have a spot in treating sure sorts of ache, however suzetrigine provides medical doctors an alternative choice. “Suzetrigine lets me add one other instrument that doesn’t have liver toxicity, doesn’t have kidney toxicity, may be very protected, and is at the least additive and perhaps even synergistic with acetaminophen and ibuprofen,” he says. “It fills a niche the place in any other case we’ve used opioids.”


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