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.