On January 30, 2025, the US FDA approved Journavx (suzetrigine) 50mg oral tablets to use in the treatment of moderate to severe acute pain, making it the first non-opioid analgesic of its class to receive federal approval in over two decades. Manufactured by the biotechnology company Vertex Pharmaceuticals, this non-opioid painkiller does not have addictive properties, unlike opioids often used for this type of pain.
“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,” said Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research.
In two clinical trials, Journavx was tested on adults between ages 18 and 80, where it was found to reduce moderate to severe acute pain from baseline by about 50% in 48 hours. Journavx inhibits the NaV1.8 pain signal in the peripheral nervous system. This channel is not expressed in the brain or anywhere else in the central nervous system, which is why it does not have opioid-like addictive properties. Journavx was found to be similarly effective as hydrocodone, an opioid pain medication for reducing acute pain, with the added benefit of not being an opioid and addictive drug. More than 80% of patients in this trial rated Journavx as a good, very good, or excellent pain medication when investigating multiple acute pain types. A couple of limitations with this drug is that it cannot be used with certain drugs that strongly inhibit a certain enzyme in the liver, which is why some people might not be able to take Journavx, depending on what other medications they take. Foods and drinks containing grapefruit should also be avoided while taking this drug. A wider availability of selective pain signal inhibitors, like suzetrigine, could encourage the exploration of non-opioid analgesics. With only mild side effects reported by clinical trial participants, Journavx could potentially become a standard for post-surgical pain management, which could lead to greater clinical research.
The new drug “offers a safer option for managing moderate-to-severe acute pain, reducing reliance on opioids,” Dr. Jianguo Cheng, a professor of anesthesiology and medical director of the Cleveland Clinic Consortium for Pain at Cleveland Clinic. “It offers rapid relief and can be integrated into postoperative pain protocols or acute pain scenarios where immediate relief is critical. By managing acute pain effectively, [Journavx] may help prevent the transition to chronic pain, reducing the need for long-term pain management strategies.”
