Expanded Access Update

As many of you know, the Multidisciplinary Association for Psychedelic Studies (MAPS) is working toward FDA approval for patients with post-traumatic stress disorder (PTSD) to be treated with MDMA through Expanded Access. MDMA has already passed Phase I (safety and dosage) and Phase II (efficacy and side effects) clinical research trials. In Phase III, they are further evaluating efficacy and safety. Research thus far has shown that it may cause durable remission of treatment-resistant PTSD, and we all feel people shouldn’t have to wait until 2021 or 2022 when it is projected that the FDA will provide full approval of the therapy. The FDA may soon agree to have a selection of Expanded Access sites take on a limited number of patients initially, and then add additional sites and patients over the next couple of years, if initial safety data is good enough. There is a lot of energy and excitement and we are prepared to take off as soon as we get a green light from the FDA and MAPS. We are hoping to begin providing this therapy as early as Spring of 2020, but this timeline is subject to change. We are ready for anything and excited to continue to organize as a community and create the professional connections that will be needed to make this all work.