As strong believers in the power of psychedelic therapy, we have been closely following Lykos Therapeutics’ efforts to get MDMA-assisted therapy FDA-approved for post-traumatic stress disorder (PTSD).
While the FDA announced on August 9, 2024, that it would not approve MDMA-Assisted Therapy at this time, we at Elument, along with many of the 13 million Americans who suffer PTSD are relieved that this is not the end of the road. There is still substantial hope that MDMA therapies will become available in the future.
Why? The FDA’s decision was primarily based on the structure and execution of the clinical trials conducted by Lykos, rather than the medicine itself. Because of this, the FDA requested an additional Phase 3 Study to be conducted. Lykos is working with the FDA to ensure that their next application has the highest possibility of success.
The set-back from this study will delay the availability of this breakthrough therapy for those suffering from PTSD, but there are other options.
THE GOOD NEWS: You Don’t Have to Wait to Work on PTSD
While MDMA therapy studies are still underway, Ketamine-Assisted Therapy (KAP) has shown positive results for PTSD, along with a significant amount of other mental health and wellness outcomes
With proven track records through formal studies as well as clients like you who have worked with us at Elument, we have witnessed the profound and transformative impacts that ketamine assisted therapy can have in people’s lives as well as its potential to shape our mental health care system by paving the way for the future approval of additional psychedelic therapy options like MDMA and psilocybin. The recognition of KAP by the National Network of Depression Centers as a viable treatment for depression, as well as the exceptional results experienced by individuals with treatment-resistant conditions, further validates our efforts.
KAP is, and always will be, an ideal therapy for those who may face barriers such as limited time, are looking for something that will be lower cost than the anticipated cost of MDMA or psilocybin, usually don’t have to transition or change current medications, or lack of access to other legal psychedelic treatments. Here is how KAP measures up to other psychedelic therapies
As you can see, our dedication to supporting Ketamine-Assisted Therapy has never been more vital.
If you are looking to deepen self-compassion, dig deep and get “unstuck”, and access your potential for more freedom and relief, we encourage you to contact us for a free consultation to learn more about Ketamine-Assisted Therapy and the different holistic services we offer.
At Elument, we’ll continue pushing for greater acceptance of psychedelic therapies in social, medical, and regulatory settings. But just know that you do not have to wait—there are therapies like KAP and non-psychedelic therapies including Hakomi, Somatic Experiencing and EMDR that provide a promising path forward.