Last week's FDA rejection of MDMA as a psychiatric treatment raises concerns and uncertainty about the fate of other potential psychedelic therapies in clinical trials.
Lykos Therapeutics plans to appeal the FDA decision asking for another large-scale trial for MDMA, expressing disappointment over the setback and the additional time and effort required.
The FDA's decision was influenced by advisory committee feedback on MDMA's trial design issues, making it challenging to assess the drug's safety and effectiveness, highlighting the importance of well-designed clinical trials.
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