A panel of experts advising the Food and Drug Administration on the use of the psychedelic MDMA for post-traumatic stress disorder found on Tuesday that the available evidence fails to show that the drug is effective or that its benefits outweigh its risks.
It represents a major setback for proponents of the drug and its sponsor Lykos Therapeutics, potentially jeopardizing FDA approval of the treatment.
Following public comment and discussion, the panel voted 9-2 that MDMA – in combination with talk therapy – is not effective for treating PTSD. And they voted 10-1 that the benefits of MDMA treatment don’t outweigh its risks.
While the FDA puts stock in the panel’s advice, it does not have to follow their recommendation.
However, that would be surprising given the host of concerns raised during the all-day meeting.
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