FDA ADVISERS WEIGH MDMA TREATMENT — The FDA is convening an advisory committee today tasked with weighing whether Lykos Therapeutics’ MDMA treatment is an effective treatment for people with post-traumatic stress disorder. We sat down with Erin to discuss her reporting on the potential therapy. What's the top line with this potential treatment? Why is it significant for veterans? Lykos Therapeutics submitted compelling clinical trial data to the FDA, which suggests that when combined with talk therapy, MDMA, also known as ecstasy, could be an effective post-traumatic stress disorder treatment. There’s a profound need for better PTSD treatments, which don’t work that well. Therapy is a common treatment, but veterans with PTSD and their families have high dropout rates. Veterans are at an increased risk for PTSD compared to the general population and at higher risk for suicide — 18 veterans die by suicide every day, according to the Department of Veterans Affairs. The FDA put out briefing documents ahead of the advisory committee today. What do they indicate? The FDA appears to have serious concerns about Lykos’ application. In briefing documents, the FDA said Lykos’ data was “challenging to interpret” and cited MDMA’s heart risks and abuse potential as safety concerns. The agency also noted that it’s hard to discern how much of the study participants’ improvement came from MDMA combined with therapy versus therapy alone. But the FDA also offered a message that advocates in the psychedelics community might interpret as hopeful, writing: “Based on the clinical trial data submitted with this application, participants appear to experience rapid, clinically meaningful, durable improvement in their PTSD symptoms.” Why are the clinical trials for this medicine being questioned? For starters, it’s hard to do double-blind studies with psychedelic drugs. It’s almost always evident who got the placebo and who got the real thing. That happened in Lykos’ trials, which were “functionally unblinded,” according to the FDA. Not having truly blind trials means bias might have infiltrated the research and skewed the results. The nonpartisan Institute for Clinical and Economic Review has also questioned the validity of Lykos’ results. They cited safety, ethical and cost concerns and projected difficulty in widely implementing the treatment. Congress seems interested in this MDMA treatment. Why is that? There’s a cohort of members in the House, including Reps. Lou Correa (D-Calif.), Alexandria Ocasio-Cortez (D-N.Y.), Jack Bergman (R-Mich.), Dan Crenshaw (R-Texas) and Morgan Luttrell (R-Texas), who have emerged as early champions of psychedelic research. I think that’s because if it works, veterans stand to benefit. The VA also appears to be on board with MDMA treatment, and MDMA studies are underway at the VA. Dr. Shereef Elnahal, the VA’s undersecretary for health, was a speaker at a psychedelics conference in New York I went to last month. Elnahal said that if the FDA approves Lykos’ application, he wants the VA to lead the way on the treatment. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. How many members of the San Francisco Giants can get injured this season? Send moral support, news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
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