WASHINGTON — Federal officers on Thursday authorized a brand new sort of ache drug designed to get rid of 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’s the primary new pharmaceutical method to treating ache in additional than 20 years, providing an alternative choice to each opioids and over-the-counter medicines 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.
Two research in additional than 870 sufferers with acute ache following foot and stomach surgical procedures confirmed Vertex’s capsule offered extra aid 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 knowledgeable 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.”
Vertex started researching the drug within the 2000s, when drug 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 on account of illicit fentanyl, not pharmaceutical medicines.
Opioids cut back ache by binding to receptors within the mind that obtain nerve indicators 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 indicators which can 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, informed the Related Press final 12 months.
Generally reported unwanted side effects with the drug had 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 Heart, 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 formidable drug pipeline that entails profitable FDA approval for a number of medicine 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 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 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 be aware to buyers, including that the outcomes jeopardized estimates that Vertex’s pipeline might 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 may yield higher outcomes and pave the way in which for FDA approval in continual ache.