The long awaited results from the MAPS Phase III clinical trial on MDMA as a therapeutic for PTSD have finally been announced. And the results are creating a euphoria throughout the psychedelic medicine space.
What’s happening:
- New highly anticipated clinical trial data from MAPS on their Phase III trial for MDMA to treat PTSD has been published
- The study shows that MDMA assisted therapy is twice as effective compared to placebo
- This is the second large clinical trial by MAPS that has validated MDMA assisted therapy is effective for PTSD
By the numbers:
- 71% of participants from the trial no longer qualified for a PTSD diagnosis after receiving MDMA assisted therapy
Why it matters:
- Since MAPS has already earned the coveted Breakthrough Therapy definition from the FDA, their results should be fast tracked for evaluation
- This means that its possible MDMA could be FDA approved by the end of the this year
- If that happens MDMA would no longer be illegal in the United States for therapeutic use and it would be able to be administered in a clinical setting
- FDA approval would also open the funding floodgates for researchers who want to do more scientific evaluation of MDMA for other types of treatments
Going deeper:
- In June, Australia recently became the first country to approve MDMA for therapeutic use and allowed physicians to prescribe it
- There has been growing discussions globally about MDMA as a therapeutic given the increasing clinical data to support it
- If MDMA does get approved by the FDA, it could open up a regulatory pathway for other countries to adopt similar policies
