The Food and Drug Administration voted 9 to 2 to reject a commercial application for MDMA (midomafetamine) as a treatment for post-traumatic stress disorder. The decision was made by the FDA's advisory committee, which found insufficient evidence to approve the drug for PTSD. The application was submitted by Lykos Therapeutics, the commercial arm of the Multidisciplinary Association for Psychedelic Studies (MAPS).
Psychedelics show promise for treating substance use disorders, particularly alcohol use disorder, in addition to their established use for post-traumatic stress disorder. A review of archives, medical literature, and conference findings indicates that these substances can be effective for addiction treatment. The evidence suggests psychedelics may offer a new therapeutic avenue for alcohol use disorder, though the text does not specify effect sizes or sample sizes.
The American Psychiatric Association issued a position statement warning about the short- and long-term risks of unapproved psychedelic and empathogenic agents. The statement notes that preliminary research into using these drugs for serious conditions like treatment-resistant depression and post-traumatic stress disorder has generated growing interest in their therapeutic potential.