An organization is seeking the US Food and Drug Administration (FDA) approval for the use of the psychedelic drug MDMA (street name Ecstasy or Molly) in combination with therapy to treat post-traumatic stress disorder (PTSD).
The MAPS Public Benefit Corporation’s new drug application (NDA) is supported by data from late-stage trials showing the benefits of MDMA-assisted therapy in reducing PTSD symptoms.
The trials involved psychotherapy in conjunction with the drug, and no serious adverse events were reported. MAPS envisions licensed healthcare professionals providing the therapy.
Why is it important?
If the FDA greenlights the drug, it would be the first psychedelic-assisted therapy in the country, marking a milestone in its integration into mainstream medical treatments.
MDMA is currently a Schedule I drug with no accepted medical use. An FDA approval would mean the Drug Enforcement Administration (DEA) would need to reclassify MDMA to allow prescriptions for patients.