The US Food and Drug Administration (FDA) approved a new pain medication, suzetrigine, on Thursday. This is the first approval of its kind in over 25 years.
What Is Suzetrigine?
Suzetrigine is a 50-milligram prescription pill taken every 12 hours, following a larger starter dose. It will be sold under the brand name Journavx. The new medication provides a non-opioid option for managing acute pain, helping to reduce risks associated with opioid use.
“This approval reflects FDA’s commitment to offering safe and effective pain alternatives,” said Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research.
Painkillers Are Widely Prescribed
Government data shows pain medications are the most prescribed drugs in US hospitals. About 80 million Americans receive prescriptions for painkillers each year. Half of these prescriptions are for opioids, which carry risks of dependence and addiction.
Suzetrigine is the first painkiller approved in the US since Celebrex, a Cox-2 inhibitor approved in 1998. Dr. Sergio Bergese, an anesthesiologist, explained that pain signals travel through nerve cells from the injury site to the brain.
How Suzetrigine Works
Suzetrigine works differently from opioids. It blocks pain-signaling nerves before they fire, preventing pain signals from reaching the brain. “Even though there’s tissue damage, the brain doesn’t sense it,” said Dr. Bergese. Unlike opioids, suzetrigine does not create a euphoric high, reducing the potential for addiction.
The drug’s development began after scientists discovered a pain-free family in Pakistan. This family lacked a key gene, preventing pain signals from firing. Despite feeling heat or touch, they didn’t sense pain. “The family’s nerves still detected touch and temperature, but not pain,” said Stuart Arbuckle, Vertex Pharmaceuticals’ chief operating officer.
A Scientific Breakthrough in Pain Relief
It took 25 years to understand and replicate this pain-blocking mechanism. “Nerve signals are like Morse code, carried by sodium channels,” explained Dr. Stephen Waxman of Yale’s Center for Neuroscience. Suzetrigine shuts down a sodium channel specific to pain signals.
After years of setbacks, suzetrigine’s approval could pave the way for more effective pain treatments. “This approval proves that targeting sodium channels can relieve pain,” said Waxman, who has no financial ties to the drug. He believes future medications may improve on suzetrigine’s effectiveness.
Clinical Trials and Effectiveness
Suzetrigine is taken as an initial 100-milligram dose, followed by 50 milligrams every 12 hours. Clinical trials included almost 600 participants recovering from abdominal and foot surgeries. Participants reported similar pain relief as those taking Vicodin, although direct comparisons were not part of the study.
On a pain scale from 0 to 10, participants’ average pain score started at 7. Suzetrigine reduced it by 3.5 points—about a 50% reduction. “It doesn’t eliminate pain entirely but cuts it in half,” Arbuckle said.
In another study, suzetrigine reduced back pain from sciatica by 2 points, similar to a placebo. Vertex believes further research will show effectiveness in chronic conditions like diabetic neuropathy, which damages nerves and causes persistent pain.
Future Outlook and Cost Considerations
The sciatica trial had fewer participants, which may have affected the results. Placebo effects, common in pain research, further complicate interpretations. Still, doctors welcome a new option. “More choices improve treatment for each patient,” said Dr. Kimberley Mauer, an anesthesiologist at Oregon Health and Science University.
Cost could be a limiting factor. Vertex set a wholesale price of $15.50 per 50-milligram pill but plans to offer patient assistance programs. “We’ll have to see how insurers respond,” Mauer said. Coverage decisions could determine how widely the drug gets used.