PRESS RELEASE: FDA Agrees to Expanded Access Program for MDMA-Assisted Psychotherapy for PTSD

[KS78]

"Today, the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) announced that the U.S. Food and Drug Administration (FDA) has agreed to MAPS’ application for an Expanded Access program for MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD).

The purpose of the Expanded Access program is to allow early access to potentially beneficial investigational therapies for people facing a serious or life-threatening condition for whom currently available treatments have not worked, and who are unable to participate in Phase 3 clinical trials."

Source: https://maps.org/news/media/8008-pr...gram-for-mdma-assisted-psychotherapy-for-ptsd

 

[S.J.B.]

Very cool. Looks more and more like the approval will happen.

 

[KS78]

Fucking great news!
"Marking an impressive milestone in the development of MDMA-assisted psychotherapy for PTSD, the U.S. Food and Drug Administration (FDA) has approved the treatment for Expanded Access, allowing certain patients access to the therapy before full market approval is granted. Ten treatment clinics in the United States are reported as ready to commence administration of the therapy, while Phase 3 trials are ongoing and full approval is estimated for 2022."

Source: https://newatlas.com/health-wellbeing/mdma-psychotherapy-ptsd-expanded-access-fda-maps/