The drug, suzetrigine, will be sold under the brand name Journavx and is the first new class of pain medicine approved in more than 20 years.
The Food and Drug Administration this week approved a new type of painkiller that doesn’t carry the risk of addiction or overdose associated with opioid medications.
The drug, suzetrigine, will be sold under the brand name Journavx and is the first new class of pain medicine approved in more than 20 years.s
“Today’s approval is an important public health milestone in acute pain management,” Jacqueline Corrigan-Curay, the acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option.”
The FDA on Thursday approved Vertex Pharmaceuticals’ Journavx to treat moderate to severe acute pain in adults. Acute pain is short-term pain often caused by surgery, accident or injury.
“Today’s approval is a historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year,” Reshma Kewalramani, CEO and president of Vertex, said in a statement. “With the approval of JOURNAVX, a non-opioid, pain signal inhibitor and the first new class of pain medicine approved in more than 20 years, we have the opportunity to change the paradigm of acute pain management and establish a new standard of care.”
Why Is the Approval Important?
The approval is considered a major breakthrough in treating acute pain without opioid medications like Vicodin and OxyContin. Reliance on opioids can lead to addiction.
More than 81,000 people in 2023 died in overdoses that involved opioids, according to federal data.
Does Journavx Work?
According to the FDA, Journavx “reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain.” That’s different from opioids, which bind to receptors in the brain that receive nerve signals from the body.
Journavx showed a “statistically significant superior reduction in pain” when compared to a placebo in two randomized trials of acute surgical pain, according to the FDA. However, it did not outperform a common opioid-acetaminophen combination pill.
But the drug’s advantage “is not its efficacy, but rather its side effect profile, including the absence of addiction potential,” Dr. Steven Cohen, a professor of anesthesiology and pain medicine at Northwestern University Feinberg School of Medicine and a Northwestern Medicine physician, said in a statement.
How Much Will Journavx Cost?
Journavx has a list price of $15.50 per pill, which is significantly more expensive than comparable opioids.
However, it’s unclear to what extent insurers could cover the medicine, and patient support programs for Journavx are available.
