The FDA rejected MDMA as a treatment for PTSD, despite positive Phase 3 trial results, due to concerns about missing adverse event data and research bias. The agency requested another trial from Lykos Therapeutics to further study safety and efficacy. In a related development, the journal Psychopharmacology retracted three papers about MDMA-assisted psychotherapy. Many authors of the studies have ties to MAPS and Lykos Therapeutics, including founder Rick Doblin and CEO Amy Emerson. The decision has disappointed drug activists and veterans who have advocated for the use of MDMA in treating PTSD. Visit STAT+ for more information.
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STAT+: Pharmalittle: We’re reading about FDA rejecting MDMA; a nasal spray for allergic reactions, and more
