How the FDA could shape the future of psychedelics research

Within the next week, the U.S. Food and Drug Administration is expected to make a decision about whether to approve the psychedelic MDMA for use in patients with post-traumatic stress disorder in conjunction with psychological intervention. Psychedelic-assisted treatment involves the use of psychedelic substances alongside traditional talk therapy for a wide range of mental health issues, including PTSD, treatment-resistant depression, severe anxiety, and substance abuse. The FDA first granted breakthrough therapy status to MDMA and psilocybin, another psychedelic substance being studied for its potential mental health applications, in 2017 and 2018, respectively, which helped to expedite their development and review. FDA expert panelists reviewed data from these two phase 3 trials, in which PTSD patients received three doses of MDMA or a placebo over a period of three months combined with sessions of psychotherapy. In the case of MDMA specifically, Lykos and other psychedelics companies could consider, for example, as one psychedelic clinical trials organization suggested, a study design to separate the efficacy of the psychedelic substance from the psychotherapy component and run four arms of the trial: psychedelic with psychotherapy, psychedelic alone, placebo with psychotherapy, and placebo alone.