Suzetrigine approved, AUD endpoints might be updated?, and more addiction news
Has the FDA already updated AUD qualified endpoints but can't say so yet?
🙊 If an FDA endpoint gets updated in the woods and no one is around to hear it, does it still encourage clinical development programs at biotechs? We’ve heard rumors from two sources that the FDA has, after 7 years of being nudged(!), updated the qualified endpoints for AUD but is not able to announce them yet because of the communications freeze. Updating endpoints for SUD indications is a big focus of our policy work and our Innovation Agenda for Addiction (see recommendation #3). Updating AUD would be a long-overdue step in the right direction, and a result of committed effort from a number of researchers, including Raye Litten at NIAAA.
💊 The FDA has approved suzetrigine! More here. It’s the first new mechanism for acute pain in decades and nonaddictive (for real, this time). All together, a big step towards a world where opioids are no longer prescribed for outpatient pain.
Vertex calls the drug “Journavx”, which is an… odd choice— I have no idea how to pronounce that and at a quick glance it look like it’s the name of a vaccine. Journavx is not a miracle drug— the efficacy is decent but not amazing— but it is likely to be the first of more nonaddictive pain medicines arriving over the next few years. As Dr. Amy Baxter has so well articulated, many patients who are prescribed post-op pain pills don’t actually need them at all, but doctors and patients find comfort in sending them home with something. Amy would rather we not continue to rely on pills, even nonaddictive ones, and instead teach different methods of relating to and working with pain. Hard to disagree but also hard to deny that Americans like pills and we’re better off giving people something that’s nonaddictive if we are going to give them something. Culture change is slow. I've written about suzetrigine efficacy here and about the market failure that will keep most patients from getting access to it while it’s on patent.
🎤 I recently spoke at at Cato Institute on GLP-1s and addiction. You can watch the talk here, it was at an event organized by our friend Jeff Singer, who has advocated for making GLP-1s available over the counter. I speak first and also take questions starting about halfway through. I also appeared on the Cato podcast: you can listen to that here.
There’s a lot more happening at CASPR these days and in addiction news, but we’re too busy to find time to write about it. We will catch up soon!