A new kind of painkiller that aims to reduce the dangers of addiction and overdose linked to opioid drugs like OxyContin and Vicodin was approved by federal authorities on Thursday.
For the short-term pain that frequently follows surgery or injury, the U.S. Food and Drug Administration announced that it had authorized Journavx from Vertex Pharmaceuticals.
It’s the first novel pharmaceutical approach to pain management in almost two decades, providing a substitute for opioids and over-the-counter drugs like acetaminophen and ibuprofen. However, the drug’s limited efficacy and drawn-out research process highlight the difficulties in developing novel pain management strategies.
Vertex’s medication was found to be more effective than a fake tablet in treating acute pain in over 870 patients who had undergone foot and abdominal procedures, but it was not superior than a typical opioid-acetaminophen combo pill.
According to Mayo Clinic pharmacist and pain management specialist Michael Schuh, who was not involved in the study, “Efficacy is not a slam dunk.” However, since it is a completely separate pathway and method of action, it is obvious. That, in my opinion, has a lot of promise.
With a quoted price of $15.50 per pill, the new medication will be far more costly than similar opioids, which are frequently sold as generics for $1 or less.
In the 2000s, when overdoses were on the rise due mostly to the widespread prescription of opioid medicines for common conditions like back pain and arthritis, Vertex started studying the drug. Prescriptions have drastically decreased over the past ten years, and illegal fentanyl—rather than prescription drugs—is the primary cause of the present opioid epidemic.
More
health
-
OHSU leader acknowledges dismal faculty morale amid fumbled layoffs, budget cuts
-
OHSU says no changes to gender-affirming care despite Trump executive order
-
Some hospitals pause gender-affirming care to evaluate Trump s executive order
By attaching to receptors in the brain that receive nerve signals from various body areas, opioids lessen pain. The addictive effects of opioids are also a result of such chemical interactions.
In contrast, Vertex’s medication blocks the proteins that cause pain signals to be transmitted to the brain.
Blocking pain transmission before it reaches the brain is a crucial step in creating medications without the addictive potential of opioids, Vertex’s Dr. David Altshuler told The Associated Press last year.
Nausea, constipation, itching, rash, and headache were among the often reported adverse effects of the medication.
Dr. Charles Argoff of the Albany Medical Center, who provided Vertex with consultation on the drug’s development, stated that the new drug’s adverse effect profiles are not only fundamentally different, but also do not include the risk of substance misuse and other significant side effects linked to opioids.
Research involving individuals with a rare genetic disorder that results in pain insensitivity gave rise to the original idea to concentrate on pain-signaling proteins.
Wall Street is interested in Vertex because of its ambitious drug pipeline, which includes obtaining FDA approval for many medications that address various types of chronic pain, which often offers a larger profit opportunity than acute pain.
However, when Vertex revealed unsatisfactory mid-stage results in a study of patients with persistent nerve pain affecting the legs and lower back in December, the Boston pharmaceutical company’s stock price fell precipitously. The study concluded that the medication did not significantly outperform a placebo.
In a research note to investors, biotechnology analyst Brian Abrahams stated, “We believe the data reflect a near worst-case scenario for this key pipeline program.” The findings also put projections that Vertex’s pipeline might be worth billions of dollars across different forms of pain in jeopardy.
However, officials at Vertex stated that they want to proceed with a new, late-stage research of the medication, speculating that a different trial design would provide better outcomes and open the door for FDA clearance in the treatment of chronic pain.
— The Associated Press’s Matthew Perrone
This report was contributed to by Mary Conlon.
The Robert Wood Johnson Foundation and the Science and Educational Media Group of the Howard Hughes Medical Institute provide support to the Associated Press Health and Science Department. All content is entirely the AP’s responsibility.
