The FDA just approved a new painkiller. Is it too good to be true?

Stop me if you’ve heard this one before: A miracle new painkiller promises to save us all from the scourge of addiction while effectively treating acute and perhaps even chronic pain. The authors of a report released last week from the Institute for Clinical and Economic Review noted several caveats: we don’t know how many patients in the phase 3 trial resorted to rescue medications ; we don’t yet have data on how suzetrigine stacks up against non-steroidal inflammatory drugs, the other main alternative to opioids but one that often comes with serious side effects or intolerability; and we don’t have data comparing suzetrigine with real-world opioid doses, which are often much higher than those used in the trial. Side effects that have been noted for suzetrigine are relatively mild, although as the authors of the ICER report noted, “We have concerns about as-yet-unknown harms of suzetrigine as we would for any drug with a new mechanism of action; we are particularly concerned about whether there could be an increased risk for cardiac arrhythmias given inhibition of NaV1.8 and possible acute renal injury given a study in people with diabetes.” "I expect to be an order of magnitude more expensive." “Analgesic efficacy is only one part of the equation — we also need randomized trials in chronic pain that look at function and long-term tolerability in comparison to NSAIDs,” Friedmann said. We need your help to stay independent Subscribe today to support Salon's progressive journalism Nevertheless, the idea that prescription opioids are deeply harmful to society seems to have a deathgrip on the cultural conversation — as Friedmann puts it, a non-addictive analgesic is “a holy grail in medicine.” It’s one we seem unable to let go, which results in non-opioids being prescribed to patients even when they are not indicated for the condition or when an opioid medication would be more appropriate for the particular patient.