In a surprisingly strong rejection of the first psychedelic therapy to come before the Food and Drug Administration, a scientific advisory panel on Tuesday overwhelmingly voted against the use of MDMA for treating PTSD, putting its approval in doubt.
At the end of a nine-hour meeting marked by sometimes-emotional testimony, the advisory committee voted 9-2 that the data do not show MDMA is effective in treating PTSD. The decision came after members critiqued the methodology of clinical trials by Lykos Therapeutics, which is seeking FDA approval for MDMA, and therapist oversight, rather than the drug itself.
The committee also voted 10-1 against a second question, on whether the benefits of MDMA outweighed the risks under the FDA’s proposed REMS program, a set of conditions placed on a drug to mitigate possible patient harms.
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