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MDMA For PTSD Moves Closer to Groundbreaking FDA Approval

September 14, 2023
x min read

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

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