WASHINGTON (AP) — Federal officers on Thursday permitted a brand new sort of ache capsule designed to eradicate the dangers of habit and overdose related to opioid medicines like Vicodin and OxyContin.
The U.S. Meals and Drug Administration mentioned it permitted Vertex Prescription 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 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.
Vertex Prescription drugs by way of AP
Research in additional than 870 sufferers with acute ache attributable to foot and stomach surgical procedures confirmed Vertex’s drug supplied extra aid than a dummy capsule however didn’t outperform a typical 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. “But it is a slam dunk in that it’s a very different pathway and mechanism of action. So, I think that shows a lot promise.”
The brand new drug will carry a listing worth of $15.50 per capsule, making it many instances dearer than comparable opioids, which are sometimes accessible 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 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 elements 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 indicators which might be later despatched to the mind.
“In trying to develop medicines that don’t have the addictive risks of opioid medicines, a key factor is working to block pain signaling before it gets to the brain,” Vertex’s Dr. David Altshuler, advised The Related Press final yr.
Generally reported unintended effects with the drug have been nausea, constipation, itching, rash and headache.
“The new medication has side effect profiles that are inherently, not only different, but don’t involve the risk of substance abuse and other key side effects associated with opioids,” mentioned Dr. Charles Argoff of the Albany Medical Middle, 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 persistent ache, which typically represents an even 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 examine of sufferers with persistent nerve ache affecting the decrease again and legs. The drug didn’t carry out considerably higher than placebo, the analysis discovered.
“We believe the data reflect a near worst-case scenario 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 examine of the drug, theorizing {that a} completely different trial design might yield higher outcomes and pave the way in which for FDA approval in persistent ache.
AP video journalist Mary Conlon contributed to this story from New York.
The Related Press Health and Science Division receives help from the Howard Hughes Medical Institute’s Science and Instructional Media Group and the Robert Wooden Johnson Basis. The AP is solely answerable for all content material.
