
New non-opioid painkiller Journavx approved by FDA - Vertex
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.
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.
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.
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."
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.
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.