Study summary

MDMA-assisted therapy was turned down by the FDA and needs another trial

MDMA therapy status · Two earlier phase 3 trials · FDA decision August 2024

What was tested

MDMA given in supervised sessions alongside talk therapy for PTSD.

What they found

• In the earlier trials, about two-thirds of people given MDMA no longer met the criteria for PTSD, against about 32% given placebo with the same therapy.
• The FDA declined to approve it in August 2024 and asked for a further phase 3 trial.
• Reviewers raised concerns that people could tell what they had received, and about how side effects were recorded.

What it means

Not available outside trials. A new phase 3 trial is the path back to the FDA.