Powerful Results, Promising Futures

Mithoefer et al. (201)

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Source: Mithoefer et al. (2010)

83% of the subjects receiving MDMA-assisted psychotherapy in a pilot study no longer met the criteria for PTSD, and every patient who received a placebo and then went on to receive MDMA-assisted psychotherapy experienced significant and lasting improvements.

These results were published in the Journal of Psychopharmacology.

 

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Source: Mithoefer et al. (2012)

A long-term follow-up of patients who received MDMA-assisted psychotherapy revealed that overall benefits were maintained an average of 3.8 years later.

These extremely powerful results indicate a promising future for MDMA-assisted psychotherapy for PTSD and lay the groundwork for continued research into the safest and most effective ways to administer the treatment.

Growing an International Research Program

A growing international research program

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MDMA-assisted psychotherapy research worldwide.

Phase 2 clinical trials of MDMA-assisted psychotherapy for PTSD are currently being conducted or planned in South Carolina, Colorado, Canada, and Israel.

Data from Phase 2 studies will be used to plan Phase 3 of MAPS' drug development program. MAPS will work with the FDA to agree on a design for Phase 3 studies, and submit the findings to the FDA in a New Drug Application (NDA) to approve MDMA-assisted psychotherapy as a prescription treatment for PTSD.

 

Phase 3 of our MDMA-assisted psychotherapy development program will involve scores of therapists and hundreds of subjects in multiple countries and large, multicenter trials. The challenge is no longer convincing regulatory agencies of the value of this research, but finding the financial resources for conducting the Phase 3 studies required to make MDMA-assisted psychotherapy a legally available treatment for those who need it most.

Additional information on the science behind MDMA-assisted psychotherapy for PTSD can be found in the sponsor’s Investigator's Brochure.

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Treating PTSD Infographic