The U.S. Food and Drug Administration (FDA) Continues Clinical Hold on Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2)

On January 30, 2020, the U.S. Food and Drug Administration (FDA) issued a second Continued Partial Clinical Hold Letter that only briefly restated the issues raised in its prior two hold letters, noting that they had not been addressed. This third clinical hold letter included no further articulation of the FDA’s rationale or any substantive response to the specific data, information, or arguments presented in MAPS’ three prior submissions (from August 29, October 11, and December 30, 2019) seeking to resolve these issues.