The U.S. Food and Drug Administration approved Journavx (suzetrigine), a first-in-class non-opioid analgesic to treat moderate to severe acute pain in adults. Acute pain is short-term pain that is typically in response to some form of tissue injury, such as trauma or surgery.  

Journavx is the first drug to be approved in a new class of pain management medicines. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain.    

FDA supports efforts to improve analgesic drug development with treatment approaches to lessen the impact of opioid use disorder, misuse, and abuse while also striking a careful balance between patient access and safety to ensure that patients suffering from significant pain have access to appropriate medication.  

The efficacy of Journavx was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute pain, one following abdominoplasty (surgical procedure to improve the shape and appearance of the abdomen) and the other following bunionectomy (surgical procedure that moves toes back into the correct position). Both trials demonstrated a statistically significant superior reduction in pain compared to placebo.  

The most common adverse reactions in study participants who received Journavx were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. Journavx is contraindicated for concomitant use with strong CYP3A inhibitors. Additionally, patients should avoid food or drink containing grapefruit when taking Journavx.