Approximately 13 million people in the U.S. struggle with PTSD and are waiting for a safe and effective treatment for this debilitating disorder.
Since the Food and Drug Administration (FDA) named MDMA-assisted therapy for PTSD a “breakthrough therapy” in 2017, trials and development of the drug have been fast-tracked by psychedelic therapy research company Lykos (formerly MAPS). These studies have shown MDMA Therapy significantly reduces the symptoms of PTSD, giving patients and their families hope as we all await FDA approval.
Why FDA Panel Voted Against MDMA Therapy for PTSD
On Tuesday June 4th, the FDA advisory board met to vote on whether MDMA therapy should be available for use to treat PTSD. This was the first time the FDA advisory panel has considered a psychedelic for medical use.
Unfortunately, the panel majority voted against both the efficacy and safety of MDMA to treat PTSD. Why? The FDA advisory board brought up several issues they had with the studies:
- This was not a double-blind study (where both the participants and therapists are unaware if the participant has taken MDMA or a placebo)
- The medicine was being treated reverentially instead of just as a medicine
- Around 40% of the participants had previously taken MDMA, which they feel could skew the results
- The potential risk of abuse
The concerns brought up by the FDA advisory panel prove to be issues with the study itself, rather than issues with the drug. This gives us hope for the future of MDMA-Assisted Therapy.
Will the FDA Approve MDMA for PTSD?
On August 11th, the full FDA will convene to approve or deny the application from Lykos to bring MDMA-Assisted Psychotherapy for PTSD to the market. Traditionally, the FDA is heavily influenced by the advisory panel’s suggestions, but we believe that even if MDMA is not approved for therapy this August, revisions to the study can be made so MDMA can be approved as a mental health treatment in the future.
Is MDMA Therapy Safe and Effective?
At Elument, we have had countless discussions with clients who have expressed the positively profound and transformative effect psychedelics have had on their lives. We have shared this experience, which is why we are strong advocates for psychedelic therapy. But the question remains: Is MDMA safe and effective for therapeutic use?
As a society, we have decades of anecdotal and evidence-based studies that point to both the efficacy and safety of psychedelics. This has been especially true when there is a structured and supported approach used in psychedelic therapy. Further, we have significant histories of psychedelic use for spiritual growth and healing in indigenous communities and it would be ethnocentric and biased to ignore the collective wisdom and history of these groups.
However, to ensure safety and best practices, our U.S. medical system requires full clinical research, testing and trials along with FDA-approval before MDMA or other psychedelics are used to treat medical conditions.
What’s Next for Patients with PTSD?
Regardless of the FDA decision, at Elument we will continue to provide high quality, supported, and evidence-based psychedelic therapy as well as experienced preparation and integration for clients who have home journeys.
We will continue to closely follow the clinical trials of numerous psychedelics, and as a current Lykos/MAPS Expanded Access program applicant, we remain ready to launch our complete MDMA-Assisted Psychotherapy treatment as soon as we are allowed.
All paths of growth, whether personal or part of an FDA clinical trial, have challenges and roadblocks. We are confident that in time, the safety and efficacy of MDMA for PTSD will be proven and that MDMA-Assisted Therapy will positively transform the lives of those struggling with the symptoms of PTSD.
We look forward to the time MDMA brings another powerful and healing psychedelic medicine to the market. While this treatment continues to navigate the regulatory process, we continue to provide high quality care with ketamine-assisted psychotherapy which is showing significant results for many suffering from PTSD.
