WASHINGTON (AP) — Federal officers on Thursday authorized a brand new sort of ache tablet designed to eradicate the dangers of dependancy and overdose related to opioid drugs 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’s the primary new pharmaceutical method to treating ache in additional than 20 years, providing a substitute for each opioids and over-the-counter drugs like ibuprofen and acetaminophen. However the remedy’s modest effectiveness and prolonged growth course of underscore the challenges of discovering new methods to handle ache.
Vertex Prescribed drugs through AP
Research in additional than 870 sufferers with acute ache on account of foot and belly surgical procedures confirmed Vertex’s drug offered extra aid than a dummy tablet however didn’t outperform a standard opioid-acetaminophen mixture tablet.
“It’s not a slam dunk on effectiveness,” mentioned 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 reveals so much promise.”
The brand new drug will carry an inventory value of $15.50 per tablet, making it many occasions costlier than comparable opioids, which are sometimes obtainable as generics for $1 or much less.
Vertex started researching the drug within the 2000s, when overdoses have 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 principally on account of illicit fentanyl, not pharmaceutical medicines.
Opioids cut 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 in a different way, blocking proteins that set off ache alerts which might be later despatched to the mind.
“In making an attempt 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, instructed The Related Press final 12 months.
Generally reported unwanted side effects with the drug have been nausea, constipation, itching, rash and headache.
“The brand new remedy has aspect impact profiles which might be inherently, not solely totally different, however don’t contain the chance of substance abuse and different key unwanted side effects related to opioids,” mentioned 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 formidable drug pipeline that includes successful FDA approval for a number of medicine throughout a number of types of power 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 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 imagine the info replicate a close to worst-case situation for this key pipeline program,” biotechnology analyst Brian Abrahams mentioned in a analysis notice to traders, including that the outcomes jeopardized estimates that Vertex’s pipeline may very well be value 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 might yield higher outcomes and pave the best way for FDA approval in power ache.
AP video journalist Mary Conlon contributed to this story from New York.
The Related Press Well being and Science Division receives assist from the Howard Hughes Medical Institute’s Science and Academic Media Group and the Robert Wooden Johnson Basis. The AP is solely liable for all content material.