WASHINGTON (AP) — Federal officers on Thursday authorized a brand new sort of ache capsule designed to eradicate the dangers of dependancy and overdose related to opioid medicines like Vicodin and OxyContin.
The U.S. 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.
Research in additional than 870 sufferers with acute ache because of foot and stomach surgical procedures confirmed Vertex’s drug supplied extra reduction than a dummy capsule however didn’t outperform a typical opioid-acetaminophen mixture capsule.
“It’s not a slam dunk on effectiveness,” stated Michael Schuh of the Mayo Clinic, a pharmacist and ache medication skilled who was not concerned within the analysis. “However it’s a slam dunk in that it’s a really totally different pathway and mechanism of motion. So, I believe that exhibits so much promise.”
The brand new drug will carry a listing value of $15.50 per capsule, making it many instances costlier than comparable opioids, which are sometimes out there 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 especially because of illicit fentanyl, not pharmaceutical medicines.
Opioids scale back ache by binding to receptors within the mind that obtain nerve alerts from totally different elements 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 are 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, advised The Related Press final 12 months.
Generally reported negative effects with the drug had been nausea, constipation, itching, rash and headache.
“The brand new medicine has facet impact profiles which are inherently, not solely totally different, however don’t contain the danger of substance abuse and different key negative effects related to opioids,” stated Dr. Charles Argoff of the Albany Medical Middle, who consulted for Vertex on the drug’s growth.
The preliminary idea to deal with pain-signaling proteins got here out of analysis involving individuals with a uncommon hereditary situation that causes insensitivity to ache.
Vertex has attracted curiosity from Wall Road for its bold drug pipeline that entails profitable FDA approval for a number of medication throughout a number of types of power 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 power nerve ache affecting the decrease again and legs. The drug didn’t carry out considerably higher than placebo, the analysis discovered.
“We consider the info replicate a close to worst-case situation for this key pipeline program,” biotechnology analyst Brian Abrahams stated in a analysis observe to traders, including that the outcomes jeopardized estimates that Vertex’s pipeline might be price billions throughout a number of types of ache.
Nonetheless, Vertex executives stated 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 power ache.
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