WASHINGTON – Federal officers on Thursday accepted a brand new kind of ache drug designed to get rid of the dangers of habit and overdose related to opioid medications like Vicodin and OxyContin.
The U.S. Food and Drug Administration mentioned it accepted Vertex Prescribed 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 treatment’s modest effectiveness and prolonged growth course of underscore the challenges of discovering new methods to handle ache.
Two research in additional than 870 sufferers with acute ache following foot and belly surgical procedures confirmed Vertex’s capsule offered extra reduction than a dummy capsule however didn’t outperform a standard opioid-acetaminophen mixture capsule.
“It’s not a slam dunk on effectiveness,” mentioned Michael Schuh of the Mayo Clinic, a pharmacist and ache medication professional 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 feel that exhibits loads promise.”
Vertex started researching the drug within the 2000s, when drug 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 current wave of the opioid epidemic is principally attributable to 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 in another way, blocking proteins that set off ache alerts 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, told the Associated Press last year.
Generally reported unwanted effects with the drug have been nausea, constipation, itching, rash and headache.
“The brand new treatment has aspect impact profiles which might be inherently, not solely totally different, however don’t contain the danger of substance abuse and different key unwanted 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 Avenue for its formidable drug pipeline that entails successful FDA approval for a number of medication throughout a number of types of continual ache, which typically represents a much bigger monetary alternative than acute ache.
However the Boston drugmaker’s share worth plummeted in December when Vertex reported disappointing mid-stage ends in a research 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 imagine the information replicate a close to worst-case state of affairs 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 could possibly 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 research of the drug, theorizing {that a} totally different trial design may yield higher outcomes and pave the best way for FDA approval in continual ache.
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AP video journalist Mary Conlon contributed to this story from New York.
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