Allaying the fears: MDMA with therapy is a medicine

The FDA might make a decision on Lykos Therapeutics’ MDMA-assisted therapy for PTSD as early as this week.

We co-authored an extensive position statement by Drug Science, PAREA, and Mind Medicine Australia published today. We are addressing key concerns discussed at the FDA Advisory Committee, namely:

-         How to regulate a treatment that comprises a combination of MDMA
and psychotherapy.
-         Blinding and expectation
-         Misuse risks of MDMA
-         Training of therapists
-         Risk of therapists’ misconduct: boundary violations
-         Uncertain long-term benefits
-         Negative benefit-risk ratio

We also touch on other factors for the FDA to consider: international developments, professional bodies’ opinions, and the way forward.