From Sage Co-Founder & Director, Genesee Herzberg, PsyD
You may have heard the news about the recent FDA Advisory Committee’s vote (9-2) against Lykos (previously MAPS PBC)’s application to approve MDMA-Assisted Therapy as a treatment for PTSD. It’s important to note that this is not a final decision made by the FDA; it is the recommendation made by their Advisory Committee. The FDA is scheduled to make their decision by August 11th of this year.
In a study of past cases since November 2022, the FDA approved ⅓ of treatments that received a negative vote from the Advisory Committee. There are various paths that could unfold on August 11th:
1️⃣ the FDA could vote not to approve the treatment at this time and instead require further research, which could take months or years, depending on the type of research required;
2️⃣ the FDA could postpone the approval date and take more time to consider the issue; or
3️⃣ the FDA could approve the treatment, likely with more stringent requirements. If approved, the DEA would then have 3 months to decide how MDMA will be rescheduled (it is currently a Schedule 1 drug and would be moved to Schedule 2 or 3). The treatment would likely become available by prescription to the public in the first half of 2025.
If you are interested in learning more about the Advisory Committee meeting, you can find brief coverage of the issue on PBS’s news briefing here, read Psychedelic Alpha’s detailed coverage and minutes here, or watch the full 10-hour advisory committee meeting here.
As one of the therapists in the MDMA-assisted therapy research, I can confirm that many of the critiques of the treatment are unfounded or insignificant compared with the notable potential this novel modality has to help millions of patients suffering from intense and intractable symptoms of trauma. This is not to minimize several individuals’ experiences of harm during the study - while some were due to the constraints of research, others offer valuable lessons we can learn from if/when this treatment is legalized. You can learn more about both the critiques and responses in this opinion piece I co-authored, signed by over 70 study researchers. Like any treatment, there is risk and potential for harm, and this needs to be carefully considered and mitigated through rigorous training, supervision, and systems of accountability. The relational, depth-oriented, and trauma-informed therapeutic method offered at Sage and taught in our training program is intended to do just this, holding ethics and safety as a foundational pillar of effective psychedelic therapy.