Statement from Sam Mandel, Co-founder and CEO of Ketamine Clinics Los Angeles (KCLA), on the Upcoming FDA Decision on MDMA-Assisted Therapy for PTSD.
As we approach the FDA’s decision on MDMA-assisted therapy for PTSD, anticipated by August 11, we at Ketamine Clinics Los Angeles (KCLA) recognize the profound implications this ruling will have on the landscape of mental health treatment. As pioneers in Ketamine Infusion Therapy since 2014, we’ve witnessed firsthand the transformative potential of innovative approaches in addressing complex mental health challenges.
The FDA’s decision, regardless of the outcome, will undoubtedly influence the future of psychoactive treatments in mental health care. Should MDMA-assisted therapy receive approval, it would mark a significant milestone in the acceptance of psychedelics as legitimate medicines. This could pave the way for broader acceptance of ketamine therapy and other promising treatments, potentially increasing access for patients who have not found relief through traditional methods.
An approval could also prompt necessary adaptations in regulatory frameworks to better accommodate treatments that combine pharmacology with psychotherapy. At KCLA, we’ve long recognized the value of this integrated approach, as evidenced by our comprehensive care model that includes Ketamine Infusion Therapy, preparation and integration, psychiatric evaluations and medication management, Transcranial Magnetic Stimulation (TMS), and other evidence-based innovations.
However, if the FDA decides not to approve MDMA-assisted therapy, it may underscore the importance of established treatments like ketamine infusions, which already have FDA approval for certain indications and are utilized off-label for various mental health conditions. Ketamine’s safety profile and efficacy in treating conditions such as PTSD, depression, anxiety, suicidality, and others, could be viewed even more favorably in this scenario.
For the 13 million Americans suffering from PTSD, 40-60% of whom do not benefit from current first-line therapies, the decision is significant. An approval could lead to increased treatment options and reduced stigma surrounding psychedelic medicines. A rejection, while disappointing for many, could refocus attention on well-established solutions that are underfunded and underutilized, like ketamine infusions.
Regardless of the FDA’s decision, we anticipate that this moment will spark increased public awareness of the exciting research on psychedelic therapies. At KCLA, we will continue to offer our patients the highest standard of care, leveraging our decade of experience and our multidisciplinary team’s expertise to provide evidence-based, personalized, comprehensive mental health care.
As we await the decision, we stand ready to adapt and evolve our practices to best serve our patients and the broader mental health community. We encourage ongoing dialogue and collaboration among all stakeholders, including but not limited to healthcare providers, researchers, Indigenous leaders, advocacy groups, investors, media, and policymakers, to ensure continued strides in improving mental health outcomes for all.
