At $15.50 a pill, Journavx costs many times what a generic opioid does. Those are often available for $1 or less. The FDA approved it anyway, on Jan. 30, 2025. The draw is the mechanism, not the price.
Journavx, the brand name for Vertex Pharmaceuticals’ suzetrigine, is cleared for moderate to severe short-term pain after surgery or injury. DW described it as the first fresh category of pain drug the United States has approved in over 20 years.
Where it acts
Opioids attach to receptors in the brain, and that is also where their addictive pull comes from. Suzetrigine stays in the peripheral nervous system. It blocks a protein known as voltage-gated sodium channel 1.8, or NaV1.8, on the nociceptors, the nerve endings in skin and tissue that detect heat or blunt force, so the signal is turned down before it ever reaches the brain. Kirsty Bannister, a neuroscientist at Imperial College London, pointed out that it leaves the nerves responsible for touch alone. “This is important, because we still need to be aware of potential or actual tissue damage so that we can take protective measures towards healing,” she said.
The idea grew out of research on people born with a rare inherited insensitivity to pain. Yale researcher Stephen Waxman and his team showed more than 25 years ago that Nav1.8 is needed for pain signaling in peripheral nerves but not in the brain.
What the trials showed
The approval rests on two large trials. Trials covering over 870 patients in pain after foot and abdominal surgery found the drug gave more relief than a dummy pill, but it did not outperform a common opioid-acetaminophen combination. Michael Schuh, a pharmacist and pain specialist at Mayo who had no part in the research, put it this way: “It’s not a slam dunk on effectiveness. But it is a slam dunk in that it’s a very different pathway and mechanism of action.”
Nausea, constipation, itching, rash and headache were the side effects reported most. Dr. Charles Argoff, who advised Vertex while the drug was being developed, said the profile carries no risk of substance abuse, which separates it from opioids.
Limits are plain. Dr. Robert Chow, a Yale Medicine anesthesiologist, expects use mainly in hospitals and for a few days, since the drug is meant for pain lasting under three months. For neuropathic pain, the picture is unsettled. DW noted that the evidence so far supports acute pain only, and AP reported that Vertex’s shares fell in December after a mid-stage study in patients with chronic nerve pain in the lower back and legs showed no significant gain over placebo.
Reshma Kewalramani, Vertex’s chief executive, called the approval “a historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year.” Bannister said Journavx is not meant to replace opioids entirely. Yale Medicine set the drug against the backdrop of nearly 727,000 U.S. opioid overdose deaths between 1999 and 2022, a figure it attributed to the CDC.
Sources
- US health agency approves brand-new painkiller (DW)
- FDA approves painkiller designed to eliminate the risk of addiction associated with opioids (AP via Scripps News)
- FDA Approves Non-Opioid Pain Medication Suzetrigine (Journavx) (Yale Medicine)
