John, In 2017, The FDA granted MDMA (pure-form ecstasy) breakthrough therapy designation and fast-tracked Phase 3 trials. They worked closely with MAPS (Multidisciplinary Association of Psychedelic Studies) to design and conduct these studies. The studies showed consistent efficacy of MDMA + Therapy with even severe, treatment-resistant PTSD, which is particularly promising for Veterans. As a result, the FDA has until
August 11th to decide on MDMA’s classification and whether or not it can be made available as a therapeutic. Last month, an advisory board of “experts” to the FDA voted to reject the reclassification, citing issues with the study. The FDA is not bound by this. “Experts” most likely means an influence of the pharmaceutical industry. The reports leave out the fact that the FDA oversaw the studies. We support the full legalization and decriminalization of MDMA, but if the best we can get for now is a reclassification so that the millions of people suffering with PTSD have a new avenue of treatment, we’ll take it and support it. As such, we are calling on the FDA to allow MDMA to be made available as a therapeutic. |
