MAPS Responds to FDA Regarding Continued Partial Clinical Hold for Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2)

On October 11, 2020, MAPS submitted a request for reconsideration on the continued partial clinical hold to the U.S. Food and Drug Administration (FDA), again responding in detail to each outstanding hold issue and concern raised by FDA regarding Study MT2. The request provided additional background information and data aimed to address the concerns FDA raised for each clinical hold item regarding the risk:benefit ratio of the study and the qualifications of the clinical investigators. As additional self-reported data to support the favorable risk:benefit ratio argued by MAPS, MAPS also offered to supply survey results collected from participants in the earlier healthy volunteer therapist training study, Study MT1, regarding their experience of the benefits and harms they experienced from their participation in the protocol.