This picture supplied by Vertex Prescription drugs in January 2025 exhibits a pill and bottle of the JOURNAVX (suzetrigine) medicine. —Vertex Prescription drugs by way of Assoicated Press
WASHINGTON — Federal officers on Thursday authorized a brand new sort of ache tablet designed to remove the dangers of dependancy and overdose related to opioid medicines like Vicodin and OxyContin.
The US Meals and Drug Administration stated it authorized Vertex Prescription drugs’ Journavx for short-term ache that usually follows surgical procedure or accidents.
It’s the primary new pharmaceutical strategy to treating ache in additional than 20 years, providing a substitute for each opioids and over-the-counter medicines like ibuprofen and acetaminophen. However the medicine’s modest effectiveness and prolonged growth course of underscore the challenges of discovering new methods to handle ache.
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Research in additional than 870 sufferers with acute ache attributable to foot and belly surgical procedures confirmed Vertex’s drug supplied extra reduction than a dummy tablet however didn’t outperform a typical opioid-acetaminophen mixture tablet.
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“It’s not a slam dunk on effectiveness,” stated Michael Schuh of the Mayo Clinic, a pharmacist and ache drugs skilled who was not concerned within the analysis. “However it’s a slam dunk in that it’s a really completely different pathway and mechanism of motion. So, I believe that exhibits quite a bit promise.”
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The brand new drug will carry a listing value of $15.50 per tablet, making it many occasions dearer than comparable opioids, which are sometimes out there as generics for $1 or much less.
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Vertex started researching the drug within the 2000s, when overdoses had been rocketing upward, principally pushed by mass prescribing of opioid painkillers for frequent illnesses like arthritis and again ache. Prescriptions have fallen sharply within the final decade and the present wave of the opioid epidemic is especially attributable to illicit fentanyl, not pharmaceutical medicines.
Opioids cut back ache by binding to receptors within the mind that obtain nerve indicators from completely different components of the physique. These chemical interactions additionally give rise to opioids’ addictive results.
Vertex’s drug works otherwise, blocking proteins that set off ache indicators which might be later despatched to the mind.
“In attempting to develop medicines that don’t have the addictive dangers of opioid medicines, a key issue is working to dam ache signaling earlier than it will get to the mind,” Vertex’s Dr. David Altshuler, informed The Related Press final 12 months.
Generally reported unintended effects with the drug had been nausea, constipation, itching, rash and headache.
“The brand new medicine has facet impact profiles which might be inherently, not solely completely different, however don’t contain the chance of substance abuse and different key unintended effects related to opioids,” stated Dr. Charles Argoff of the Albany Medical Heart, who consulted for Vertex on the drug’s growth.
The preliminary idea to concentrate on pain-signaling proteins got here out of analysis involving folks with a uncommon hereditary situation that causes insensitivity to ache.
Vertex has attracted curiosity from Wall Road for its bold drug pipeline that entails successful FDA approval for a number of medication throughout a number of types of continual ache, which usually represents an even bigger monetary alternative than acute ache.
However the Boston drugmaker’s share value plummeted in December when Vertex reported disappointing mid-stage ends in a examine of sufferers with continual nerve ache affecting the decrease again and legs. The drug didn’t carry out considerably higher than placebo, the analysis discovered.
“We imagine the information replicate a close to worst-case situation for this key pipeline program,” biotechnology analyst Brian Abrahams stated in a analysis be aware to buyers, including that the outcomes jeopardized estimates that Vertex’s pipeline could possibly be price billions throughout a number of types of ache.
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Nonetheless, Vertex executives stated they plan to maneuver ahead with a brand new, late-stage examine of the drug, theorizing {that a} completely different trial design may yield higher outcomes and pave the way in which for FDA approval in continual ache.
