Vertex Pharmaceuticals' Journavx was approved by the US Food and Drug Administration (FDA) to treat short-term pain, such as following surgery or an injury.
 
This is the first significant development in pain management in for in 20 years, providing a substitute for opioids as well as popular pain relievers like acetaminophen and ibuprofen. The medication's lengthy development period and middling efficacy, however, underscore the difficulties in developing novel approaches to pain management.
 
Journavx was shown to be more effective than a typical opioid-acetaminophen combo tablet, however it did offer superior pain relief than a placebo in clinical studies involving over 870 patients recuperating from foot and abdominal procedures.

Michael Schuh of the Mayo Clinic, a pharmacist and specialist in pain management who was not involved in the study, stated, "Efficacy is not a slam dunk." However, since it's a completely separate route 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 overdose rates were skyrocketing due mostly to the widespread prescription of opioid medicines for common conditions like back pain and arthritis, Vertex started studying the substance. Prescriptions have drastically decreased over the past ten years, and illegal fentanyl—rather than prescription drugs—is the primary cause of the present opioid crisis.
 
By attaching to receptors in the brain that receive nerve impulses 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 sent to the brain.
 
"Blocking pain signaling before it reaches the brain is a key factor in trying to develop medicines that don't have the addictive risks of opioid medicines," Dr. David Altshuler of Vertex told The Associated press last year.
 
Nausea, constipation, itching, rash, and headache were among the often reported adverse effects of the medication.
 
According to Dr. Charles Argoff of the Albany Medical Center, who provided Vertex with consultation on the drug's development, "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."
 
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 medical pipeline, which includes obtaining FDA clearance 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 findings in a study of patients with persistent nerve pain in the legs and lower back, the Boston pharmaceutical company's stock price fell precipitously in December. The study concluded that the medication did not substantially 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 types 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.
 
 
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G GOWTHAM

31/01/2025 12:22 PM