STAT June 9, 2024
At a heated advisory committee meeting convened by the Food and Drug Administration last week, regulators repeatedly expressed frustration that Lykos, a company seeking approval of MDMA-assisted therapy to treat PTSD, failed to follow instructions and track positive feelings such as “euphoria” that could be used to inform understanding of the drug’s addiction potential.
The missing data, said clinical reviewer David Millis, were “a major concern.”
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