The FDA approved suzetrigine, the first new type of pain reliever in over two decades. This prescription medication, taken every 12 hours after an initial larger dose, will be sold under the brand name Journavx.
A Non-Opioid Solution for Pain Relief
Dr. Jacqueline Corrigan-Curay, acting director at the FDA’s Center for Drug Evaluation and Research, emphasized its importance. She explained that the new non-opioid class offers an alternative to opioids, aiming to reduce addiction risks while providing effective pain management.
Painkillers are the most prescribed drugs in hospitals, according to government surveys. Annually, about 80 million Americans fill pain-relief prescriptions, with half involving opioids. Vertex Pharmaceuticals, the developer of suzetrigine, confirmed that opioids often lead to dependence and addiction.
Suzetrigine is the first painkiller approved since 1998 when Celebrex, a Cox-2 inhibitor, entered the market. Dr. Sergio Bergese, an anesthesiologist, described how pain signals travel from damaged tissues through nerves to the brain. Unlike opioids, suzetrigine prevents pain-signaling nerves from firing, stopping the sensation before it reaches the brain.
“This drug interrupts pain pathways,” Bergese explained. “Even though the injury is present, the brain doesn’t recognize it.” Importantly, suzetrigine does not create euphoria or cause addiction.
The drug’s development was inspired by a family of fire walkers in Pakistan who lacked a pain-signaling gene. Researchers discovered that, while the family could feel heat and touch, they experienced no pain from hot coals. This finding led scientists on a 25-year journey to develop suzetrigine.
Dr. Stephen Waxman of Yale’s Center for Neuroscience explained that pain signals travel through neurons using electrical impulses powered by sodium channels. Suzetrigine works by closing one specific sodium channel responsible for transmitting pain signals.
Waxman highlighted its significance: “This provides proof that blocking sodium channels can reduce pain in humans, paving the way for more effective future drugs.”
Clinical Trials and Future Applications
Suzetrigine is available in two dosages. Clinical trials involving nearly 600 participants evaluated its effectiveness in managing post-surgical pain. Participants who had abdominal or foot surgeries reported that suzetrigine reduced their pain by at least half, similar to those taking Vicodin.
On average, participants with pain levels around seven on a 0-10 scale experienced a reduction of about 3.5 points. “It’s not complete pain elimination,” said Stuart Arbuckle, Vertex’s chief operating officer. “But it reduces pain by roughly 50%.”
However, a study involving people with sciatica-related back pain showed mixed results. Suzetrigine reduced pain by 2 points, the same as the placebo. Vertex believes the study’s small size—around 100 participants—affected its outcome.
Despite this, the company remains optimistic about suzetrigine’s potential for chronic pain management. Ongoing trials are examining its effectiveness for diabetic neuropathy, which causes nerve damage, tingling, and pain.
Placebo effects, common in pain studies, may have contributed to mixed results. “In our view, the drug performed as expected,” Arbuckle said.
Dr. Kimberley Mauer, an anesthesiologist at Oregon Health and Science University, welcomed the new option. “The more treatments we have, the better we can customize care for individual patients,” she noted.
Vertex priced the drug at $15.50 per 50-mg pill. Patient assistance programs are planned, but insurance coverage could affect accessibility. “Costs might limit some patients,” Mauer said. “We’ll need to wait and see how insurers respond.”
