FDA Approves First New Type of Non-Opioid Painkiller in Over 20 Years
The U.S. Food and Drug Administration (FDA) has approved JOURNAVX™ (suzetrigine), the first new type of pain medication in over 20 years. Developed by Vertex Pharmaceuticals, JOURNAVX is a non-opioid, highly selective NaV1.8 pain signal inhibitor designed to treat moderate-to-severe acute pain.
“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,” said Vertex CEO Dr. Reshma Kewalramani. The company believes the drug has the potential to “change the paradigm of acute pain management” by offering an effective alternative to opioids.
How does JOURNAVX work?
Unlike opioids, which alter pain perception in the brain and carry risks of dependence and addiction, suzetrigine works by blocking pain-signaling nerves in the peripheral pain sensing neurons that transmit the pain signals to the brain. This means patients can experience relief without the euphoric effects that contribute to opioid misuse.
“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 Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research in their news release about the drug.
The inspiration for JOURNAVX
The drug’s development was inspired by a family in Pakistan who lacked a gene that allows pain signals to fire in the skin. This genetic discovery led scientists to investigate NaV1.8 sodium channels, which play a key role in transmitting pain signals. After 25 years of research, Vertex successfully created a drug that selectively blocks these channels, preventing the transmission and therefore sensation of pain signals without interfering with other sensations.
Clinical trials showed that suzetrigine effectively reduced pain following surgeries such as foot and abdominal procedures. On a standard pain scale from 0 to 10, participants who started at an average pain level of seven experienced a reduction of about 3.5 points. While not eliminating pain entirely, the drug offered relief comparable to opioids like Vicodin, though the studies were not designed to make a direct comparison.
Non-Opiate painkiller comes at crucial time in ongoing opioid crisis
The drug’s approval comes amid an ongoing opioid crisis, with millions of Americans relying on opioids for pain relief each year. “This is an incredible day for patients and physicians alike who now have an approved non-opioid treatment that delivers effective acute pain relief and a favorable safety profile without addictive potential,” said Dr. Jessica Oswald, an emergency and pain medicine specialist.
“I believe JOURNAVX could redefine the management of pain and become a foundational treatment option for people with all types of moderate-to-severe acute pain, where options aside from opioids have been so desperately needed.” JOURNAVX aims to provide a safer alternative for those at risk of prolonged opioid use or addiction.
JOURNAVX will be available by prescription in the U.S., with a wholesale cost of $15.50 per 50mg pill. It is taken twice daily after an initial loading dose. However, it is not yet approved for use in children, and certain medications, including some hormonal contraceptives, may be affected by suzetrigine. Patients are advised to discuss their medications with a healthcare provider before starting treatment.
Vertex is also studying suzetrigine’s potential for chronic pain conditions, including diabetic neuropathy. While results have been promising, a study involving sciatica patients showed no significant difference between suzetrigine and a placebo. Researchers suggest that additional trials may be needed to fully assess its effectiveness for long-term pain management.
“It is an important step forward, because it provides proof of concept that a [sodium-channel blocker] can reduce pain in humans,” said Dr. Stephen Waxman of Yale School of Medicine. Experts believe that suzetrigine’s success could pave the way for future non-opioid pain treatments, potentially revolutionizing pain management for millions of patients.
Vertex Pharmaceuticals Incorporated. (2025) 'Vertex announces FDA approval of JOURNAVX™ (suzetrigine), the first-in-class non-opioid analgesic for moderate to severe acute pain'. Available at: https://news.vrtx.com/news-releases/news-release-details/vertex-announces-fda-approval-journavxtm-suzetrigine-first-class (Accessed: 31 January 2025).
U.S. Food and Drug Administration. (2025) 'FDA approves novel non-opioid treatment for moderate to severe acute pain'. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain (Accessed: 31 January 2025).
