Thu, 30 Jan 2025

FDA approves Vertex’s non-opioid painkiller, first new kind of pain medicine in decades

The Vertex drug is a milestone after a long history of unsuccessful efforts to develop painkillers without the addictive potential of opioids.

* The FDA has approved Vertex Pharmaceuticals' non-opioid painkiller pill, Journavx, for the treatment of moderate-to-severe acute pain.
* Journavx is a new type of pain medicine that works by blocking pain signals at their origin before they reach the brain, unlike opioids which act directly on the brain to block pain.
* The approval marks a milestone in the development of alternative painkillers without the risk of addiction, and could become a blockbuster drug with estimated annual sales exceeding $1 billion.
* The medication has been shown to be effective in reducing pain intensity after 48 hours in two late-stage studies, and had lower rates of adverse side effects compared to placebo.
* Vertex's CEO, Dr. Reshma Kewalramani, said that the approval "gives us the opportunity to change the paradigm of acute pain management and establish a new standard of care".
* The FDA has stated its commitment to approving safe and effective alternatives to opioids for pain management, and is encouraging developers to create more non-opioid painkillers.
  >>