FDA Grants Breakthrough Therapy Designation for MDMA-Assisted Psychotherapy for PTSD

MDMA-assisted psychotherapy is a novel treatment package that combines psychotherapeutic techniques with three administrations of MDMA as a pharmacological adjunct.

August 2017

Highlights from MAPS website:

  • Breakthrough Therapy Designation ensures that FDA will work closely with MAPS to complete Phase 3 trials as efficiently as possible.
  • MAPS and FDA have also reached agreement on design, primary endpoint, and statistical approach for Phase 3 trials.
  • Posttraumatic stress disorder (PTSD) is a serious and life-threatening psychiatric condition with unmet medical need despite available treatments.
  • MAPS is sponsoring two Phase 3 clinical trials of MDMA-assisted psychotherapy in patients with severe PTSD starting in 2018.
  • MAPS, a non-profit research organization, has raised or pledged half of the $25 million estimated cost of these trials, with $12.5 million still needed.