FDA Approves Non-Opioid Treatment for Moderate to Severe Acute Pain
The U.S. Food and Drug Administration approved Journavx™ (suzetrigine) 50mg oral tablets, the first drug approved in a new class of pain management medicine.
On 30 January 2025, the U.S. FDA approved Journavx™ (suzetrigine) 50mg oral tablets for use in the treatment of moderate to severe acute pain. This is the first non-opioid analgesic of its class to receive federal approval in over two decades.
The drug’s analgesic properties come from highly selective inhibition of the NaV1.8 channel without the addiction potential seen in opioid-based medications. The NaV1.8 channel – which is not expressed in the central nervous system – acts as an allosteric mechanism to stabilize the closed state of the channel to reduce pain signals in primary human dorsal root ganglion (DRG) sensory neurons.
The drug, clinically tested for acute surgical pain and post-bunionectomy pain, is the first of its kind to be approved by the FDA.
“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.
According to a press release, Vertex Pharmaceuticals is also currently evaluating the efficacy of suzetrigine for the treatment of peripheral neuropathic pain, painful diabetic peripheral neuropathy, and painful lumbrosacral radiculopathy.
A wider availability of selective pain signal inhibitors, like suzetrigine, could alter the acute pain management landscape and should encourage the exploration of new research avenues for non-opioid analgesics. With only mild to moderate side-effects reported by clinical trial participants, Journavx could potentially become a standard for postsurgical pain management (and perhaps other pain indications) following greater clinical availability and research.