A day after a panel of advisers to the Food and Drug Administration expressed deep concerns about the use of MDMA to help treat post-traumatic stress disorder, companies working to develop other psychedelics said their optimism had not been dimmed — and that the concerns provided a clearer blueprint for what it might take to get such a drug approved.
The advisory committee overwhelmingly voted that Lykos Therapeutics, which is seeking FDA approval for MDMA and therapist oversight, rather than just the drug itself, had failed to demonstrate that the therapy would be effective in treating PTSD. Members of the panel also concluded that the potential benefits of the treatment did not outweigh the risks, though they noted it was a promising treatment modality.
STAT spoke with nearly a dozen companies developing psychedelics on Wednesday, and none seemed particularly shocked by the panel’s findings, noting that Lykos’ approach has been plagued with controversy for years.
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