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The recent FDA rejection of MDMA-assisted therapy for PTSD put forth by Lykos Therapeutics has left the psychedelic drug development and mental health communities at a critical juncture, reigniting discussions about the future of innovative mental health treatments. As the industry faces this significant setback, the question emerges: where do we go now?
The FDA’s Decision: A Call For Further Research
On Aug. 9, 2024, the FDA issued a Complete Response Letter (CRL) to Lykos Therapeutics, rejecting its application for MDMA-assisted therapy for post-traumatic stress disorder (PTSD). The decision was not entirely unexpected, given the complexities surrounding the approval of such a novel treatment. The FDA requested an additional Phase 3 trial to address concerns about the therapy’s safety and efficacy, particularly issues related to expectancy bias and the necessity of combining psychotherapy with MDMA treatment.
Lykos Therapeutics expressed deep disappointment with the FDA’s decision. CEO Amy Emerson voiced the frustration felt by many, stating, “The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades.” Emerson’s comments underscore the immense need for new therapeutic options, especially for conditions like PTSD, where traditional treatments have largely fallen short. Despite this setback, Lykos remains committed to exploring all available regulatory pathways to bring this potentially transformative treatment to those who need it most.
The Industry Responds With Determination
The FDA’s decision has not dampened the resolve of the psychedelic community. On the contrary, it has galvanized industry leaders and advocates to push even harder for the acceptance and integration of psychedelic therapies into mainstream medicine. Amber Capone, CEO and cofounder of VETS, an organization focused on providing psychedelic-assisted therapies to veterans, emphasized the dire need for new treatments. “This development is merely another hurdle in our ongoing mission to end the veteran suicide epidemic,” Capone stated, reflecting the urgency and high stakes involved in this work. With an estimated 20 to 44 veterans dying by suicide each day, the need for innovative treatments like MDMA-assisted therapy has never been more pressing.
Capone’s determination mirrors a broader sentiment within the psychedelic industry — a steadfast commitment to continue advocating for MDMA-assisted therapy despite regulatory setbacks. She highlighted that while the FDA’s commitment to ensuring safety is understandable, the cost of inaction, measured in lives lost to untreated PTSD, is too high. VETS, along with other organizations, remains committed to conducting rigorous research, providing access to therapies abroad where possible, and advocating for the approval of these treatments on U.S. soil.
Kathryn A. Walker, CEO of Revitalist Lifestyle and Wellness Ltd., offered a perspective on the broader challenges of integrating these treatments into traditional medicine. Revitalist is a mental health and wellness company focused on comprehensive care in the ketamine wellness space, offering innovative, evidence-based services. Walker emphasized that the current regulatory framework is not equipped to handle the unique aspects of psychedelic therapies. “Psychedelics are here to break the mold,” Walker stated, highlighting the need for new regulatory standards that can accommodate the innovative nature of these treatments.
Exploring Alternatives While Still Seeking Responsible Innovation
With the FDA’s decision not to approve MDMA-assisted therapy, mental health professionals are now faced with the challenge of finding alternative ways to support their patients. Shari B. Kaplan, LCSW, an Integrative Mental Health Clinician at Cannectd Wellness, and a strong advocate for MDMA’s potential, reflected on what therapists can do moving forward. While Kaplan had hoped that MDMA would be approved due to what she believes is its unique ability to facilitate rapid and profound therapeutic breakthroughs — achieving in a single 5-hour session what conventional pharmaceuticals might take weeks or months to accomplish — she acknowledges the need to adapt in light of this decision.
Kaplan urges therapists to continue focusing on innovative, evidence-based approaches that can still offer meaningful support to their patients. She highlights the importance of leveraging the principles that made MDMA-assisted therapy so promising, such as enhancing neuroplasticity and optimizing the therapeutic environment, even without the drug itself. This means integrating other modalities that promote similar biochemical and emotional shifts, such as trauma-informed care, advanced psychotherapy techniques, and holistic wellness practices.
Additionally, Kaplan stresses the critical role of rigorous screening and patient selection, particularly when considering alternative treatments that may have different but significant impacts on mental health. Therapists must remain vigilant in assessing each patient’s suitability for various therapies, ensuring that interventions are not only effective but also safe.
Embracing Non-Hallucinogenic Psychedelic Medicine
The FDA’s decision to reject MDMA-assisted therapy for PTSD has undeniably created a significant obstacle. Still, it also has catalyzed a broader and more nuanced conversation about the future of psychedelic medicine. One of the most intriguing avenues emerging from this discussion is the potential of non-hallucinogenic alternatives, which could offer similar therapeutic benefits without the complexities and challenges associated with traditional psychedelics.
Joseph Tucker, Ph.D., CEO of Enveric Biosciences, offered valuable insight into the issues spotlighted by the FDA’s decision. “The thematic challenges that came to light in the Lykos Adcomm largely focused around two elements: expectation bias and the delivery of the psychological therapy,” Tucker explained. These concerns are deeply intertwined with therapies that involve hallucinations and require extensive psychotherapy, making them difficult to disentangle from the overall treatment process. However, Tucker pointed to the emerging field of non-hallucinogenic neuroplastogens as a promising solution. These next-generation compounds could potentially replicate the therapeutic effects of traditional psychedelics, such as MDMA, while sidestepping the regulatory and clinical hurdles associated with hallucinogenic experiences. This could lead to more widespread acceptance and use of psychedelic medicine within mainstream healthcare, offering patients the benefits of these therapies without the associated risks.
Expanding on this theme, Sandeep Prakash, Ph.D., cofounder & chief scientific officer at SoundSelf, emphasized the importance of seeking more accessible and lower-risk mental health solutions in light of the FDA’s decision. “While it’s disappointing for those who saw MDMA-AT as a promising treatment, it’s also a reminder of the importance of exploring alternative and innovative approaches to mental wellness,” Prakash remarked. He highlighted the need to refocus efforts on standardizing preparation and integration therapies, ensuring they are more patient-centric and adaptable to individual needs.
Prakash also introduced the idea of integrating advanced therapeutic tools like SoundSelf into these treatment protocols. SoundSelf, which is already being successfully used in ketamine and esketamine clinics, provides patients with a personalized, immersive experience that can deepen their therapeutic journey. By incorporating such tools into the preparation and integration stages of psychedelic therapy, practitioners can enhance the overall treatment process, offering holistic care that not only supports the immediate therapeutic experience but also fosters long-term transformation. This approach could bridge the gap between traditional and innovative mental health treatments, ensuring patients receive comprehensive care tailored to their unique experiences and needs.
The conversation surrounding non-hallucinogenic alternatives and advanced therapeutic tools underscores a pivotal shift in the field of psychedelic medicine. As the industry continues to evolve, these innovations may pave the way for more inclusive and widely accepted mental health solutions, ultimately broadening access to the transformative benefits of psychedelic-assisted therapy.
Moving Forward: A Commitment To Innovation And Advocacy
The path forward for MDMA-assisted therapy and the broader psychedelic industry is clear: continue advocating for innovation, conduct rigorous research, and push for new regulatory frameworks that recognize the unique nature of these treatments. While the FDA’s rejection of MDMA-assisted therapy is undoubtedly a setback, it is seen by many in the field as just another step in the long journey toward revolutionizing mental healthcare.