FDA Accepts Request for Rolling Review of MDMA-Assisted Therapy

On November 2, 2021, the U.S. Food and Drug Administration (FDA) granted MAPS PBC’s request for rolling submission and review of portions of our planned new drug application (NDA) for MDMA. Rolling Review, a benefit of Breakthrough Therapy and Fast Track designations, allows (but does not require) the FDA to initiate early review of NDA components.

MDMA-assisted therapy for PTSD has received both Breakthrough Therapy and Fast Track designations from the FDA as part of MAPS and MAPS PBC’s efforts to accelerate the FDA approval process while meeting all scientific and clinical criteria.

View or download the letter below.