If you’ve been waiting for the green light on psychedelics for mental health issues, you’ll have to wait a little longer.
In August 2024, the FDA denied approval for MDMA (ecstasy), disappointing those hoping to see a quick change in treatment options for conditions like PTSD, including Dr. Karen Giles and our Atlanta-based team at Breakthru Psychiatric Solutions.
However, while MDMA and psilocybin offer potential, there are other treatments available now that can make a difference.
Here, Dr. Giles explains the recent FDA decision regarding MDMA, what it means for the future of psychedelics, and introduces Prism — a current FDA-approved treatment that can help while we wait for wider psychedelic legalization.
When the FDA decided not to approve MDMA as a treatment for PTSD, it left many disappointed. The decision came despite promising results in clinical trials, which showed MDMA-assisted therapy could significantly reduce PTSD symptoms.
The FDA stated concerns about the long-term safety of MDMA, as well as the need for additional research to verify its effectiveness.
The denial means that researchers must go back to the drawing board and conduct more studies to address the FDA’s concerns. Although this delays the availability of MDMA-assisted therapy, it also ensures that when it does become available, it will be safe and effective.
Psilocybin, another promising psychedelic, is also under FDA review. The decision on MDMA sets a precedent that could impact psilocybin’s approval process, requiring researchers to undergo similar scrutiny. We are still a few years away from psilocybin being approved for treatment-resistant depression.
Despite the setback with MDMA, research into psychedelics continues to advance. Studies on psilocybin, LSD, and other psychedelics are ongoing, with many showing promising results for treating mental health conditions.
Organizations like the Multidisciplinary Association for Psychedelic Studies (MAPS) are at the forefront of psychedelic research. They continue to advocate the therapeutic potential of psychedelics and fund studies to support their approval.
Though the FDA’s decision is a setback, it doesn’t signal the end of psychedelic research. The field is growing, and many researchers are optimistic that with further study, psychedelics will eventually be approved for medical use.
Psychedelics are an untapped spring of potential benefits and unique therapeutic effects that could transform mental health treatment, such as:
Psychedelics can help you process emotions more deeply, allowing you to confront and resolve traumatic experiences and reduce PTSD and depression symptoms.
Psychedelics can enhance the therapeutic alliance between you and Dr. Giles. Psychedelics induce an altered state of consciousness that creates a sense of trust and openness, facilitating deeper therapeutic work.
Research suggests that the therapeutic effects of psychedelics can be long-lasting. Patients often report sustained improvements in their mental health months or years after a single psychedelic-assisted therapy session.
While we wait for MDMA and psilocybin to receive FDA approval, other effective treatments are available for PTSD, including Prism.
Prism is a self-neuromodulation-based treatment for PTSD and anxiety that helps you get control of your symptoms. It targets a biomarker of the amygdala to address the root of PTSD symptoms rather than the symptoms themselves.
With no medicine and no need to revisit your trauma, this treatment offers a promising way to respond to PTSD.
Studies show that Prism effectively reduces PTSD symptoms and improves overall mental health. Breakthru is one of the first 15 clinics in the country to offer this new modality of treatment.
Even though the FDA’s decision to deny MDMA approval is a setback, it doesn’t mark the end of the road for psychedelic research — many researchers are optimistic about the future of these drugs.
Dr. Giles continually monitors the current research and is qualified and ready to administer psychedelics as soon as Georgia receives the green light.
For more information on psychedelics, Prism and other treatment options, call Breakthru Psychiatric Solutions in Sandy Springs, Georgia, or schedule an appointment online.