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A group of prominent researchers and clinicians have published a consensus statement backing the use of MDMA-assisted therapy for post-traumatic stress disorder (PTSD). This statement comes as FDA is reviewing a New Drug Application for midomafetamine (MDMA) for the condition.
“On the basis of the safety and efficacy data we have seen, assuming the integrity of the data is validated by the relevant regulators, and in light of the very urgent and widespread unmet need for effective treatments for PTSD, we believe that midomafetamine (MDMA) is now approvable for use with therapy in the treatment of PTSD, given suitable safeguards and post-approval monitoring,” they write in the opening of the statement.
The signatories include Bob Jesse, a significant figure in the field of psychedelic research, known for his work with psilocybin at Johns Hopkins University. Also among the experts are Dr. Barbara O. Rothbaum, Professor in Psychiatry at Emory University School of Medicine, and Dr. Bessel van der Kolk, (author of the popular book “The Body Keeps the Score“). Van der Kolk is also a professor of psychiatry at Boston University School of Medicine.
The authors of the statement note that an estimated 13 million Americans suffer from PTSD. Current therapies, such as cognitive-behavioral therapy (CBT), prolonged exposure therapy and selective serotonin reuptake inhibitors (SSRIs), fail to achieve remission in more than half of treated patients.
A number of companies are also vying to win FDA approval for the magic mushroom compound, psilocybin, a classic psychedelic, for depression.
Efficacy of MDMA-assisted therapy
The signatories statement highlights the positive data from two placebo-controlled Phase 3 clinical trials that found significant improvements in PTSD symptoms for patients receiving MDMA-assisted therapy. In 2023, the Multidisciplinary Association for Psychedelic Studies (MAPS) supporting the studies predicted MDMA would achieve regulatory approval this year.
In the studies, MDMA recipients faired significantly better than those getting placebo.
- 87% of MDMA group participants achieved a clinically meaningful response, compared to 66% in the placebo group.
- 69% of MDMA recipients no longer met PTSD diagnostic criteria. That is compared to 41% in the placebo group.
- Finally, 40% of MDMA group participants achieved remission, compared to 14% in the placebo group.
The trials found that these improvements were durable, persisting for at least six months after treatment. A total of 39% of the MDMA group were still in remission at follow-up.
The recent statement note that MDMA-assisted therapy has been shown to be generally safe and well-tolerated in clinical trials. They explain that MDMA has been studied for more than four decades and that serious adverse events are rare even in unsupervised, non-medical settings. They also acknowledge, however, the need for careful monitoring and post-approval studies to address any remaining medical concerns.
Despite the positive clinical trial results, an FDA advisory committee voted 9–2 against recommending MDMA-assisted therapy for PTSD on June 4, 2024.
Australia endorses therapeutic psychedelics
While the U.S. deliberates, Australia has recently legally sanctioned psychedelic-assisted therapy in some cases, as Bloomberg noted. On July 1, 2023, Australia became the first country in the world to legalize the medical use of MDMA for treating PTSD, along with psilocybin for treatment-resistant depression. This decision by Australia’s Therapeutic Goods Administration (TGA) reclassified these substances from prohibited to controlled drugs for medical applications.
The FDA’s final decision on the approval of MDMA-assisted therapy for PTSD is expected by August 11, 2024. If approved, it could open the door to more psychedelic therapies for mental health treatment in the U.S.
Filed Under: Psychiatric/psychotropic drugs, Regulatory affairs
