WEDNESDAY, June 5, 2024 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel on Tuesday voted against recommending the psychedelic MDMA for the treatment of post-traumatic stress disorder (PTSD).
In a 10-1 vote, the panel determined the evidence amassed so far fails to show the controversial drug's benefits outweigh its risks, the reported. During the meeting, panel members pointed to flawed study data and significant drug risks, including the potential for heart problems, injury and abuse. “It seems like there are so many problems with the data -- each one alone might be OK, but when you pile them on top of each other .
.. there’s just a lot of questions I would have about how effective the treatment is,” , a psychologist with the Department of Veterans Affairs, said during the meeting, the reported.
The FDA is expected to make a final decision by August, but the panel's vote could bolster the agency’s reasoning for rejecting the treatment, the reported. MDMA is the first in a series of psychedelics -- including LSD and psilocybin -- that are expected to come before the FDA for review in the next few years, the reported. But on Tuesday, the FDA advisers pointed to flawed studies that could have skewed the results on MDMA, missing follow-up data on patient outcomes and a lack of diversity among participants.
The vast majority of patients were white, with only five Black patients receiving MDMA, the reported. Lykos Therapeutics, the company behind the .
