Northeastern pain and addiction expert Ganesh A. Thakur explains what Journavx means for sufferers of acute and chronic pain.
A novel painkiller approved Thursday by the FDA promises to relieve post-surgical suffering while avoiding the addictive qualities of opioid medications.
Boston-based Vertex Pharmaceuticals, which developed the oral treatment called Journavx for people with moderate to severe acute pain, says it’s “the first new class of pain medicine approved in more than 20 years.”
It is a big step in developing painkillers without the risk of addiction, says Ganesh A. Thakur, chair of Northeastern’s Department of Pharmaceutical Sciences.
“This is definitely a major advancement in pain management because this is a first of its kind,” says Thakur, who has worked in pain and addiction research for two decades.
“This is a very powerful compound that works on acute pain,” he says, defining acute as short-term conditions such as post-surgical pain.
Journavx works by blocking pain signals in the peripheral nervous system before they reach the brain, unlike opioids. Opioid medications such as Vicodin and OxyContin work on receptors in the brain and end up triggering powerful reward systems.
Thakur calls Journavx “a novel compound with a novel mechanism of action.”
“Opioids block the brain’s perception of pain, whereas this compound blocks the transmission of the pain at the initial site of the injury,” he says. “So the injury is there, but the pain doesn’t reach the brain.”
Also known as suzetrigine, Journavx is a class of new drug called a sodium channel blocker.
Think of a car being blocked from entering a highway, Thakur says. “That is your sodium channel blocker. It does not let the pain signal go through to the highway.”[GT1]
“With opioids, the car gets onto the highway and keeps moving because the feeling of pain has been eased,” he says. “Opioids work at the brain’s ‘toll booth.’ They don’t stop the cars (pain signals) from moving but try to make you ‘care less’ about pain. “There is an altered perception at the brain level.”
Clinical data collected on hundreds of Journavx patients showed no evidence of withdrawal or drug-seeking behaviors, Thakur says, adding that more information about the drug will be known once it is clinically prescribed.
The FDA says the efficacy of Journavx was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute pain, one involving abdominal surgery and the other bunionectomy.
“Both trials demonstrated a statistically significant superior reduction in pain with Journavx, compared to placebo,” the FDA says.
The most common side effects were itching, muscle spasms, rashes and liver issues, Thakur says.
Some physicians fear the relatively high price of Journavx — $15.50 per pill, compared to about $1 for an OxyContin HCI tablet — will discourage insurers from covering the new medication.
Cost is an issue, Thakur says. But he says he expects insurers to be motivated to reduce the use of opioid treatments both because of side effects such as constipation and respiratory depression but also due to the role they play in addiction and overdoses.
“Drug overdoses are connected to the use of fentanyl and abuse compounds, which has origins in the opioids market” of the late 20th century, Thakur says.
“I would say this is not going to take out opioids from the market completely,” he says. For starters, Journavx has yet to show evidence of reducing chronic pain or the severe pain associated with late stage cancers.
But “it’s a big step,” Thakur says. “People have been talking about sodium channel innovators for a long time. It’s a billion dollar loss when you try to develop drugs, take it to advanced stages and they fail. I’m very happy to see that Vertex did an amazing job in advancing this compound.”