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

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 drugs, bought beneath the model identify Journavx and made by Vertex Prescribed drugs, are taken twice a day and characterize 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 the moment essentially the most potent and efficient strategy to management ache, they’re related to a major threat of dependancy, and have fueled an epidemic of dependancy and overdose deaths within the U.S. in current many years. From 1999 to 2017, deaths from overdose as a consequence of prescription opioids elevated greater than seven occasions, exposing a dire want for efficient however nonaddictive methods to handle ache.

Here 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 completely different ones are lively in numerous 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 might be discovered all through the physique however not within the mind. The medicine 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, nonetheless, took many years of analysis, which was all of the tougher since sodium channels by definition work shortly—so their results, and the results of any compounds designed to regulate them, are laborious to measure. As soon as researchers recognized the precise sodium channel that was selectively lively in ache nerves, referred to as Nav 1.8, scientists at Vertex combed by means of libraries of compounds to seek out an efficient inhibitor to dam the opening of the channel. “We screened tons of of 1000’s of compounds on the lookout 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 forms of surgical procedure—bunion elimination and tummy tucks—that represented two main forms of pain-generating harm: to bone and delicate 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 better and quicker discount in ache in comparison with these taking placebo drugs; amongst these getting abdominoplasty, 61% of these taking suzetrigine reported not less than 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 does not carry the danger of dependancy. “We noticed sufferers reporting enormous 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 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 a wide range of situations.

Might it work for power ache?

Vertex can also be exploring whether or not suzetrigine might handle power ache, which often stems from a extra complicated and sprawling set of situations than acute ache. These outcomes have been much less stable to this point. Amongst sufferers with sciatica, those that obtained suzetrigine and those that received a placebo reported equally small reductions in ache after 12 weeks.

Nonetheless, Negulescu says the corporate is transferring forward with later-stage testing to raised regulate for the placebo impact and higher perceive the drug’s impact in power ache. “Our perception is that the Nav1.8 mechanism goes to be related in each acute and power ache,” he says.

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Persistent ache may be traced to 2 major mechanisms, Negulescu says. One impacts muscular tissues 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 sort of power ache happens when the nerves themselves are broken, which happens in situations like diabetes, particularly in peripheral tissues like fingers and toes. “We imagine the mechanism of suzetrigine is related in each musculoskeletal and neuropathic ache,” says Negulescu. “Our working speculation, based mostly on the information now we have, is that Nav1.8 continues to be expressed and current in power situations.”

How the approval might change ache administration

As efficient as suzetrigine is, it doesn’t utterly 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 potential to get higher at exactly controlling the sodium-channel ache sign to realize better ache administration. “We’re coming 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 drugs had been related to comparatively few unintended effects—a serious distinguisher from opioids. “That is the primary examine I’ve ever carried out the place the side-effect profile for folks on placebo was worse than the side-effect profile for folks 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 consultants see its potential in treating extra critical ache, if over-the-counter treatments don’t work. Ideally, ache consultants imagine it could possibly be the first-line remedy after surgical procedures and minor procedures, together with dental procedures, as a substitute of the opioids which might be at the moment prescribed.

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