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FDA Panel Recommends Against MDMA-Assisted Therapy for PTSD

Experts cite insufficient evidence of effectiveness and concerns over trial integrity; FDA decision pending.

  • The advisory committee voted 9-2 against approving MDMA for PTSD treatment.
  • Concerns were raised about unblinded trials and underreported adverse events.
  • Lykos Therapeutics conducted the trials, which showed promising but controversial results.
  • Public testimonies highlighted both the potential benefits and ethical issues of the therapy.
  • The FDA will make the final decision by August 11.
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