The initial application from Lykos presented positive data from two late-stage clinical trials that used MDMA in combination with talk therapy to treat PTSD.
The advisers said it was also difficult to parse how much the accompanying talk therapy — an area that the FDA does not regulate — contributed to outcomes.
Advocates for the treatment, including some veterans groups, said they were “incredibly disappointed” by the FDA decision.
Dozens of clinical trials involving psychedelics are in various stages, and additional scrutiny can help strengthen the findings and build confidence.
Psychopharmacology did not allow the study authors to publish a correction with data that excluded findings from one study site, said Allison Feduccia, an author in all three retracted studies.
Persons:
Lykos, —, ” Martin Steele, Brett Waters, ”, Rachel Yehuda, “, ‘, Michael Bogenschutz, Yehuda, It’s, Lori Bruce, Psychopharmacology, caressed, “ it’s, Amy Emerson, ” Lykos, Allison Feduccia, Dr, Sanjay Gupta, Brian Barnett, ” Bruce, Nadia Kounang
Organizations:
CNN, Food and Drug Administration, Lykos Therapeutics, FDA, Veteran Mental Health Leadership Coalition, Hope, Center, Psychedelic Psychotherapy, Mount, Icahn, of Medicine, NYU Langone Center, Psychedelic Medicine, Oxford, NUS, Neuroethics, Interdisciplinary Center, Bioethics, Yale University, ”, Multidisciplinary Association for Psychedelic Studies, Health Canada, Institutional, Board, CNN Health, Cleveland Clinic
Locations:
Canada, “