FDA APPROVES NEW PAIN PILL DESIGNED TO ELIMINATE ADDICTION AND OVERDOSE RISKS
The US Food and Drug Administration has approved a new type of pain pill designed to eliminate the risks of addiction and overdose associated with opioid medications. The new pill, Journavx, developed by Vertex Pharmaceuticals, has been approved for short-term pain management following surgery or injuries. According to the FDA, Journavx is the first new pharmaceutical approach to treating pain in over 20 years, offering an alternative to both opioids and over-the-counter medications like ibuprofen and acetaminophen. However, studies have shown that the medication’s effectiveness is modest, and it did not outperform a common opioid-acetaminophen combination pill in clinical trials. Michael Schuh, a pharmacist and pain medicine expert at the Mayo Clinic, noted that while Journavx’s effectiveness is not overwhelming, its unique mechanism of action shows promise. “It’s not a slam dunk on effectiveness,” Schuh said. “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 of promise.” Journavx works by blocking proteins that trigger pain signals to the brain, rather than binding to receptors in the brain like opioids. This mechanism of action reduces the risk of addiction and overdose. Common side effects reported with the drug include nausea, constipation, itching, rash, and headache. Dr. Charles Argoff of the Albany Medical Center, who consulted for Vertex on the drug’s development, noted that Journavx’s side effect profile is inherently different from opioids and does not involve the risk of substance abuse. “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,” Argoff said. The list price of Journavx will be $15.50 per pill, making it significantly more expensive than comparable opioids, which are often available as generics for $1 or less. Vertex began researching the drug in the 2000s, when opioid overdoses were rising sharply. While prescriptions for opioids have fallen in recent years, the opioid epidemic continues to be a major public health concern.