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Psychedelic Community Reacts To FDA Committee’s Critique Of Lykos’ MDMA Studies

Guest Column | June 14, 2024

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As told to Abby Proch, executive editor of guest columns, Clinical LeaderClinical Trial Face

This past week, an FDA advisory committee voted 9-2 to reject the validity of therapy-assisted MDMA clinical trials conducted by Lykos Therapeutics for the treatment of PTSD. The FDA does not have to side with a committee, but it often does. To get a sense of the psychedelic drug development community’s reaction, we posed the following question to some of its leaders across pharmaceutical companies, healthcare providers, and mental health advocacy groups:

From your perspective, what does the committee’s vote mean for the pursuit of MDMA and other psychedelic therapies — those currently in clinical trials and those for which companies are preparing an IND?

Here’s what they think of the committee’s decision and how it will affect the future of psychedelic clinical research.

Sam Clark, MD, Ph.D., founder and CEO, Terran Biosciences

“I was disappointed with the vote as I felt that the points raised overlooked the large effect sizes observed in the trials as well as the dire need for better treatments for PTSD, a serious condition associated with high suicide risk.

The committee stated that additional safety lab data and more comprehensive documentation around future abuse liability should be provided. This feedback will certainly guide other companies developing psychedelic therapies in future clinical trial design, however, for MDMA this data could be obtained after FDA approval in a comprehensive REMS program and via careful post-marketing surveillance.

One of the major points discussed was functional unblinding, the idea that patients could identify that they had been given active drugs due to the effects they experienced. However, functional unblinding is a phenomenon that has occurred in other trials of FDA-approved neuropsychiatric drugs, including the antidepressant esketamine, and should not be used as a reason to delay the approval of MDMA. Future trials of psychedelics may attempt to address this through the inclusion of multiple dose strengths. Overall, I agree with Dr. Walter Dunn who voted that the drug was effective and that the benefits outweighed the risks.” 

Acacia Parks, advisory board member, Lindus Health

“Despite setbacks faced by Lykos Therapeutics, the rejection of their MDMA clinical trial findings should not undermine the promising potential of psychedelic drugs in treating conditions like PTSD, treatment-resistant depression, and opiate addiction. While concerns about research quality and ethics are paramount, it’s crucial to differentiate between issues with a specific drug program and the broader therapeutic efficacy of psychedelics. The challenges encountered by Lykos do not reflect shortcomings of MDMA as a therapy for PTSD, nor do they discredit the future of psychedelics in psychiatry. Our focus must remain on robustly demonstrating therapeutic benefits, ensuring that setbacks like these are understood not as failures of the drugs themselves, but rather as issues within the study protocols.”

Kristie Tse, founder, Uncover Mental Health Counseling

“The FDA advisers’ decision against MDMA trials underscores the ongoing skepticism about psychedelic-assisted therapies. This pause, however, should not deter the exploration of innovative treatments. Current data from Lykos’s trials indicate that, with the right safety protocols, MDMA could significantly help PTSD patients. As a psychotherapist dedicated to evidence-based practices, I stress the importance of continued research in this promising area. The therapeutic potential of psychedelics in controlled, supportive environments remains high. This decision highlights the necessity for rigorous clinical trials. To advance this field, we need interdisciplinary collaboration and dialogue with regulatory bodies. Aligning safety standards is critical for progress. Ensuring emerging treatments meet high efficacy and safety benchmarks is a priority. We must serve diverse populations with the best possible care.

Kathryn Walker, MSN-Anesthesia, MSN-Psychiatry, CEO and founder, Revitalist

”MDMA paired with psychedelic therapy is a unique class of drugs that has yet to be created under the pharmacologic lens of the FDA. While we seek to have these therapies accepted into traditional medicine, we must understand that the path has yet been paved. We cannot expect the FDA to accept a medication coupled with therapy as the FDA has not been created in that manner, therefore, we must advocate for the necessary regulations and standards to show efficacy in real-world data when medications are coupled with psychotherapy. Psychedelics are here to break the mold; we have to understand we have to create the mold around the psychedelic as the drug was not meant to function in the same realm as our traditionally broken system.”

Steve Elfrink, advisor, Webdelics

“I have reservations about MAPS’ MDMA studies. As a participant in an FDA psilocybin study, I witnessed participant bias firsthand. The pressure to contribute positively to the research skewed subjective questionnaires. Enthusiastic hype can compromise data integrity.

My primary concern with MAPS’ protocol is the limit of three MDMA sessions. While effective for single or recent traumas, it falls short for those with complex PTSD (C-PTSD) or pre-verbal trauma. Clients with C-PTSD often need more extensive therapy to address deep-seated issues. For example, a client of mine saw limited improvement with three MDMA sessions but achieved significant breakthroughs with additional somatic therapy and low-dose ketamine/cannabis.

Another issue is the lack of standardized psychotherapy protocols and insufficient support for destabilized participants. Some experience severe side effects like depersonalization, highlighting the need for better trauma understanding and dissociation management.

Despite these concerns, I support the legalization of MDMA, provided we improve data collection, protocols, and screening processes. We must balance enthusiasm with caution, ensuring safety and efficacy based on personal and professional experiences in the psychedelic space.”

Joseph Tucker, Ph.D., CEO, Enveric Biosciences

“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. These are difficult to separate from any therapy that induces hallucinations and/or requires psychotherapy in the treatment protocol but would likely be eliminated as concerns for the impending next generation of non-hallucinogenic neuroplastogens. Some speculate that these and other advantages of the non-hallucinogenic neuroplastogens could result in them displacing hallucinogenic psychedelics to become the predominant new entrant to neuropsychiatric medicine that emerges from the psychedelics field.”

Oded Kraft, co-founder and CEO, of GrayMatters Health

“In recent years, increased PTSD awareness has highlighted the need for innovative treatments, including MDMA. The FDA panel’s findings are a setback for psychedelic therapies, but they should not hinder progress on PTSD therapy innovation.

PTSD is personal for every patient and no single treatment works universally. FDA-cleared, drug-free, non-trauma-based therapies, such as self-neuromodulation technology, are available and can be immediately implemented while psychedelics are explored. Some patients prefer not to use drugs as part of treatment, so having a spectrum of treatments to select from is critical.

To give patients the best chance of treatment success, a holistic approach is needed. Expanding the PTSD treatment toolkit is therefore vital, ensuring both patients and clinicians are aware of and have access to all FDA-cleared therapeutic options.”

Janet Qi, CEO, PurMinds NeuroPharma

”The FDA advisory vote against MDMA-assisted therapy trials underscores the challenges facing psychedelic therapies. This decision stresses the need for rigorous, well-designed clinical trials to demonstrate safety and efficacy. Lykos, as the pioneer in psychedelic drug development, allowed the industry as a whole a critical learning experience. This will help the fast followers, such as PurMinds, in resolving many of the issues identified by FDA advisors.

At PurMinds, we are committed to advancing the scientific and clinical understanding of psychedelic compounds through meticulous research and innovative formulations, such as our proprietary psilocybin formulation and non-hallucinogenic novel chemical entities. Despite regulatory setbacks, we believe in the potential of psychedelics to revolutionize neurological care and remain steadfast in our pursuit of evidence-based therapies.”

Joe Perekupka, CEO, Freespira

“The recent FDA decision regarding MDMA raises valid concerns about potential abuse and side effects, highlighting the need for caution when exploring novel treatments for mental health disorders. However, it is crucial to recognize the importance of diversity in therapeutic approaches to address the complex nature of mental health conditions. As the healthcare community continues to explore various treatment options, it is essential to prioritize safe, evidence-based solutions that can provide effective relief to those in need. Non-invasive approaches that patients can use in the comfort of their own homes offer a promising avenue for addressing symptoms of conditions such as PTSD and panic disorder without the risks associated with pharmacologic treatments.

Robust clinical data should support any treatment option, demonstrating significant reductions in symptoms without adverse effects. By ensuring that solutions meet the highest safety standards and deliver sustainable, effective relief, we can better serve the needs of individuals struggling with mental health disorders.

While the development of novel treatments is essential, it is equally important to fully utilize the clinically-validated treatments currently available. By leveraging existing evidence-based solutions and exploring innovative approaches with caution and rigorous testing, we can work toward providing a comprehensive range of safe and effective mental health treatment options.”

Amber Capone, cofounder and CEO, VETS

“As an organization dedicated to providing military veterans with access to psychedelic-assisted therapies, VETS is deeply disappointed by the FDA panel’s decision not to recommend approval of MDMA-assisted therapy for PTSD. We have seen the profound impact this treatment can have on the lives of veterans struggling with the debilitating symptoms of PTSD, offering hope and healing where other treatments have failed. The high rates of veteran suicide and the limited effectiveness of currently approved PTSD treatments underscore the urgent need for innovative approaches like MDMA-assisted therapy.

While we acknowledge the panel’s concerns regarding the clinical trial design and potential risks, we believe these issues can and should be addressed through rigorous therapist training, patient monitoring, and ongoing research. VETS calls on the FDA to carefully consider the compelling testimony from PTSD sufferers who have found relief through MDMA-assisted therapy and to work collaboratively with researchers, therapists, and patient advocates to establish a safe and effective framework for this promising treatment.

Our veterans have sacrificed so much in service to our nation, and they deserve access to every possible avenue for healing and recovery. We will continue to fight for expanded research, funding, and regulatory support for psychedelic-assisted therapies until every veteran has the opportunity to reclaim their lives from the grip of PTSD.”

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