The U.S. Food and Drug Administration (FDA) made headlines last week with the approval of suzetrigine, marketed under the brand name Journavx, a groundbreaking new non-opioid, non-addictive medication for treating moderate to severe acute pain. This marks the first new pain medication approved in over 25 years and has been granted to Vertex Pharmaceuticals Incorporated.
This announcement comes at a critical time as opioid misuse, addiction, and overdose deaths remain significant public health concerns in the United States. According to provisional data from the Centers for Disease Control and Prevention (CDC), there were approximately 107,543 drug overdose deaths in the U.S. during 2023.
Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, highlighted the significance of this development: "Today’s approval represents a crucial milestone in acute pain management. The introduction of a new non-opioid analgesic class offers an alternative that reduces certain risks associated with opioids, providing patients with additional treatment options. This action underscores the FDA's dedication to approving safe and effective alternatives to opioids."
Journavx is administered as a 50-milligram prescription pill every 12 hours, following an initial 100-milligram dose. Unlike opioids, which affect the brain, Journavx targets pain-signaling pathways in the peripheral nervous system—outside the brain and spinal cord—before pain signals reach the brain.
One of the most exciting aspects of this new medication is its lack of euphoric effects ("high"), meaning it does not carry the potential for addiction or dependence, according to the manufacturer and researchers.
The discovery of Journavx began with a fascinating real-world observation. Scientists studied a family in Pakistan known for their ability to walk on hot coals without experiencing pain. They found that these individuals lacked a specific gene responsible for transmitting pain signals in response to heat. It took researchers 25 years to translate this genetic insight into a viable pharmaceutical solution.
The efficacy of Journavx was assessed in two comprehensive studies involving patients recovering from either abdominal or foot surgery. Participants received either suzetrigine or a placebo post-surgery, with ibuprofen available as needed for additional pain relief. Both trials demonstrated statistically significant improvements in pain reduction among those who received suzetrigine compared to those who received a placebo.
On a pain scale from zero to ten, where zero represents no pain and ten indicates excruciating pain, participants reported an average pain level of seven before receiving any treatment. After taking Journavx, their pain levels decreased by 3.5 points, representing about a 50% reduction in pain.
Common side effects observed in study participants included itching, muscle spasms, and rash. Patients are advised to avoid consuming grapefruit or its juice while taking Journavx.
Cost could influence how widely the drug is adopted. Vertex has set the wholesale price at $15.50 per 50-mg pill, though patient assistance programs will be available to help make the medication more accessible.