FDA Reviews MDMA-Assisted Therapy for PTSD as Congress Pushes Psychedelic Research

If approved, this would mark the first psychedelic-assisted therapy, potentially driving new investment in mental health research and changing the treatment landscape for PTSD.

MAPS Public Benefit Corp. has filed an application with the FDA to approve the use of MDMA in combination with therapy to treat PTSD, marking a significant milestone in the quest to bring psychedelic drugs into mainstream medical treatments.
If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, potentially driving additional investment into new research in mental health.
The FDA could impose strict rules around who can prescribe MDMA and what pharmacies or facilities can dispense the drug, with potential for significant restrictions.
The National Defense Authorization Act of 2024 includes a provision to fund clinical trials using psychedelic substances, including MDMA, to treat active duty members of the military with PTSD or a traumatic brain injury.
The FDA has designated both MDMA and psilocybin as 'breakthrough therapies', a special designation given to expedite the research and development into drugs with the potential to treat serious conditions.