WASHINGTON — Federal officers on Thursday authorized a brand new sort of ache tablet designed to remove the dangers of habit and overdose related to opioid medicines like Vicodin and OxyContin.
The U.S. Meals and Drug Administration mentioned it authorized Vertex Prescribed drugs’ Journavx for short-term ache that usually follows surgical procedure or accidents.
It is the primary new pharmaceutical method 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 remedy’s modest effectiveness and prolonged improvement course of underscore the challenges of discovering new methods to handle ache.
Research in additional than 870 sufferers with acute ache resulting from foot and belly surgical procedures confirmed Vertex’s drug offered extra aid than a dummy tablet however did not outperform a typical opioid-acetaminophen mixture tablet.
“It is not a slam dunk on effectiveness,” mentioned Michael Schuh of the Mayo Clinic, a pharmacist and ache medication knowledgeable who was not concerned within the analysis. “However it’s a slam dunk in that it is a very totally different pathway and mechanism of motion. So, I feel that exhibits loads promise.”
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 obtainable as generics for $1 or much less.
Vertex started researching the drug within the 2000s, when overdoses had been rocketing upward, principally pushed by mass prescribing of opioid painkillers for widespread illnesses like arthritis and again ache. Prescriptions have fallen sharply within the final decade and the present wave of the opioid epidemic is principally resulting from illicit fentanyl, not pharmaceutical medicines.
Opioids scale back ache by binding to receptors within the mind that obtain nerve alerts from totally 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 alerts which might be later despatched to the mind.
“In attempting to develop medicines that do not 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, instructed The Related Press final 12 months.
Generally reported unintended effects with the drug had been nausea, constipation, itching, rash and headache.
“The brand new remedy has aspect impact profiles which might be inherently, not solely totally different, however do not contain the danger of substance abuse and different key unintended effects related to opioids,” mentioned Dr. Charles Argoff of the Albany Medical Middle, who consulted for Vertex on the drug’s improvement.
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 formidable drug pipeline that includes profitable FDA approval for a number of medication throughout a number of types of continual ache, which usually represents a much bigger monetary alternative than acute ache.
However the Boston drugmaker’s share value plummeted in December when Vertex reported disappointing mid-stage leads to a examine of sufferers with continual nerve ache affecting the decrease again and legs. The drug did not carry out considerably higher than placebo, the analysis discovered.
“We consider the information mirror a close to worst-case situation for this key pipeline program,” biotechnology analyst Brian Abrahams mentioned in a analysis observe to buyers, including that the outcomes jeopardized estimates that Vertex’s pipeline may very well be price billions throughout a number of types of ache.
Nonetheless, Vertex executives mentioned they plan to maneuver ahead with a brand new, late-stage examine of the drug, theorizing {that a} totally different trial design may yield higher outcomes and pave the way in which for FDA approval in continual ache.
Copyright © 2025 by The Related Press. All Rights Reserved.
