FDA Assessing MAPS’ Application for MDMA as Treatment for PTSD
The MAPS Public Benefit Corporation (MAPS PBC), a psychedelics-focused, drug-development company, has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA). MAPS PBC is asking the FDA to approve the use of MDMA (ecstasy, molly) as a prescription medication for treating post-traumatic stress disorder (PTSD). The company is requesting that the federal agency provide an expedited review of the psychedelic as the FDA had already designated it as a breakthrough therapy. The FDA granted breakthrough therapy designation for MDMA in PTSD treatment in 2017 and reached an agreement with MAPS to design two MDMA phase…






