An advisory panel for the Food and Drug Administration (FDA) has voted against approving MDMA for Post-Traumatic Stress Disorder (PTSD). This is a disappointing outcome for people who believe in the effectiveness of therapeutic psychotropic medication and hope to see it made available for PTSD treatment. The FDA does not have to follow the recommendation of its advisory panel, but the outlook is bleak for obtaining FDA approval.
The 9 and a half hour hearing is available on Youtube. Reports of the meeting suggest that the experts were concerned about the quality of the study design and data practices of Lykos. Lykos is widely regarded for its psychological research under it’s previous form MAPS, but is new to the world of pharmaceutical trials.
One of the primary criticisms of the study was the lack of attention given to side-effects and contra-indications. This is critical information for providers to have when prescribing the medication. A secondary criticism is that Lykos did not do enough to ensure that the experiments were double-blind. The final concern is that Lykos’ therapy model is not considered evidence-based, and the FDA is not qualified to evaluate therapeutic models, so an essential component of the study was an inscrutable “black box” to the FDA experts.
O’Reilly Trauma Healing offers Ketamine Assisted Psychotherapy (KAP), which is a legal medication that is available today. Ketamine is widely considered to be safer and more predictable for therapy than MDMA, and has been used to treat depression, anxiety, and PTSD/CPTSD among other diagnosis. However, we all have different brains; there is no one-size-fits-all approach to therapy. We support the continued research around therapeutic psychotropic medication and hope for more and more options to provide healing for those who suffer from PTSD and CPTSD.
Further Reading:
Ars Technica: Flawed, scandalous trials tank FDA expert support for MDMA therapy
Why non-profit MAPS created the for-profit Lykos subsidiary to fund research
2018 Allegations of sexual abuse of a client under MDMA influence by MAPS-affiliated researcher
