A club drug could be the next big thing in treating mental illness. That’s if an FDA advisory committee agrees on Tuesday that MDMA, or ecstasy, helps treat post-traumatic stress disorder when combined with talk therapy, our Erin Schumaker reports. The FDA's decision is a huge moment for psychedelic research, said Andrew Penn, a psychiatric nurse practitioner and clinical professor at the University of California, San Francisco who's previously worked with Lykos Therapeutics, the maker of the treatment. If the FDA says "yes," it will likely galvanize support for early-stage psychedelic research. If the FDA says "no," it could give those same researchers pause, he said. Lawmakers and officials at the VA are hopeful the committee will find that Lykos' application supports approval. And the company’s data is striking. Sixty-seven percent of participants with severe PTSD who received MDMA combined with therapy no longer met the diagnostic criteria for the disorder, compared with 32 percent in the group that received therapy and a placebo, according to Lykos' Phase 3 study, which was published in Nature in 2021. Why it matters: There's a profound need for better PTSD treatments. Current options are notoriously ineffective, with many people with PTSD left white-knuckling through daily life. Veterans are especially hard hit. The VA cites research finding 7 percent of veterans will suffer from PTSD at some point in their lives. It can cause flashbacks, nightmares and anxiety brought on by traumatic events – like combat. Nearly one in four vets who seek care at a VA facility have the condition, had it or will get it. Even so: In March, an independent, nonpartisan group that evaluates new drug applications found Lykos’ trials suspect. And last month in Senate testimony, the head of the National Institute on Drug Abuse, Nora Volkow, compared the hype for psychedelics as a cure for mental illness to belief in “fairy tales.” Rebuttal: Lykos CEO Amy Emerson responded to critics in a public comment saying their critique discounts “significant unmet medical need” and that the FDA is best-equipped to evaluate its treatment’s safety and efficacy.
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