FDA Grants Appeal in Formal Dispute Resolution Regarding Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2)

On April 16, 2021, nearly two years following the initial protocol submission of MT2 to the U.S. Food and Drug Administration (FDA), the FDA Office of Neuroscience granted MAPS’ Formal Dispute Resolution Appeal.

The deciding official issued a letter, agreeing on all counts with the arguments submitted by MAPS in response to the partial clinical hold issues. The letter specifically notes that Study MT2 does not carry a more unfavorable risk:benefit ratio than prior studies and that clinical investigators requirements should not be held to a different standard than prior approved studies (Study MT1). With this decision, clinical investigators should not be required to have a doctoral level degree, and that physicians should not be required on site.