In this week’s Psychedelic News Roundup, we examine an ambitious new study planned by MAPS-Israel involving 400 survivors of the October 7th Hamas attacks. Other news includes the FDA acceptance of Lykos Therapeutic’s new drug application for MDMA, a potential cannabis-based cancer treatment, and the controversial rebranding and restructuring of MAPS PBC (now Lykos Therapeutics).

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MDMA Therapy for October 7 Attack Survivors: A New Horizon in PTSD Treatment

As detailed by the Intercept, MAPS Israel plans to initiate a groundbreaking study offering MDMA-assisted psychotherapy to 400 Israeli survivors of the October 7 Hamas attack. This diverse group, encompassing civilians, released hostages, and soldiers, will participate in what is set to be the most extensive study of its kind, marking a significant step toward integrating psychedelic medicine into mainstream healthcare. Dr. Keren Tzarfaty, CEO and co-founder of MAPS Israel, emphasized the universal application of this therapy model, aiming to demonstrate its safety and effectiveness for broader global adoption. This study not only seeks to address PTSD but also to foster open hearts and expanded minds among participants.

This initiative by MAPS Israel, an affiliate of the U.S.-based MAPS, is pioneering in its approach to group MDMA therapy, a novel concept in the realm of psychedelic research. The potential of MDMA, known for inducing empathic feelings, as a revolutionary treatment for mental health issues like PTSD is gaining recognition even from the U.S. government. With the FDA on the brink of approving MDMA for PTSD therapy and the Department of Veterans Affairs and Congress exploring psychedelic treatments, the landscape of mental healthcare is evolving. MAPS Israel’s study stands out by administering MDMA in small groups, a strategy believed to be beneficial for collective traumas and more cost-effective, addressing the urgent need for scalable PTSD treatments.

However, the study’s backdrop of ongoing conflict and its repercussions on Palestinian mental health raises critical questions about healthcare disparities and the broader impact of such therapies. The severe conditions in Gaza, wrought by the war, highlight a grave need for mental health support amidst impossible evaluation and treatment conditions. MAPS is making efforts to increase access to MDMA-assisted therapy for Palestinians, training facilitators, and planning studies for survivors of sexual abuse, reflect a commitment to bridging this gap. Yet, the challenge remains immense, with the healthcare disparity between Israelis and Palestinians under Israeli occupation starkly evident.

Amidst this complex scenario, the inclusion of festival goers from the Nova music event, many of whom experienced trauma while under the influence of psychedelics, introduces an additional layer of complexity to the study. This unique group’s response to psychedelic-assisted therapy could offer new insights into treating traumas experienced in altered states of consciousness. With over a thousand survivors already seeking help, the urgency for effective, scalable treatment solutions is palpable.

As the study progresses, with private funding nearly secured and partnerships with leading hospitals forged, the anticipation builds for its potential impact. The collaboration between Israeli and Palestinian therapists, the group therapy model, and the focus on collective trauma not only aim to heal individuals but also to contribute to societal transformation. In navigating the delicate balance between healing trauma and addressing the ongoing conflict’s complexities, this study could pave the way for a new era in mental health treatment, emphasizing the power of empathy and understanding in overcoming the deepest of divides.⁽¹⁾

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FDA Accelerates Review of MDMA Therapy for PTSD

An article published by Marijuana Moment explores how the Food and Drug Administration (FDA) has taken a pivotal step by agreeing to prioritize the review of MDMA-assisted therapy as a potential breakthrough treatment for Post-Traumatic Stress Disorder (PTSD). This announcement comes from Lykos Therapeutics, the psychedelics-focused drug development company spearheading this innovative approach. Just two months after the submission of the new drug application (NDA) for MDMA in conjunction with psychotherapy, the FDA has not only granted it priority review status but also set a target decision date for August 11.

Lykos Therapeutics, evolving from MAPS Public Benefit Corporation with a recent rebranding and investor inclusion, has presented extensive clinical trial data to the FDA, showcasing MDMA’s effectiveness in treating moderate to severe PTSD. This development follows the 2017 designation of MDMA as a “breakthrough therapy” by the FDA, acknowledging the promising results from earlier MAPS-sponsored trials. The application builds on findings from 18 Phase II and Phase III clinical trials, highlighting a significant milestone in the potential pharmaceutical approval of a psychedelic substance for therapeutic use.

Amy Emerson, CEO of Lykos, emphasized the urgency for innovative treatments in addressing PTSD and the company’s commitment to ensuring a controlled, quality launch pending FDA approval. The expedited review process, now slated for completion within six months, marks a critical phase in potentially making MDMA-assisted therapy available for those grappling with PTSD significantly sooner than the standard review timeline.

Rick Doblin, President of MAPS, has expressed hope that FDA approval of MDMA-assisted therapy for PTSD will pave the way for other psychedelic-assisted treatments to become prescription-available, celebrating the collective efforts of therapists, study participants, and the Lykos team in reaching this historical juncture.

As the psychedelic research field gains momentum, with the FDA drafting unique research guidelines and the American Medical Association implementing psychedelics-specific codes, the potential federal approval of MDMA for therapeutic use stands as a testament to the evolving recognition of psychedelics’ medical benefits. This initiative aligns with growing legislative and regulatory interest in the therapeutic potential of psychedelics, seen in actions by states like Colorado and Oregon, as well as countries like Australia, signaling a significant shift in the treatment landscape for PTSD and possibly other conditions.⁽²⁾

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Cannabis Extract Shows Potential Against Melanoma in Preliminary Research

An article in Science Alert examines how researchers are investigating a concentrated cannabis extract named PHEC-66, developed by MGC Pharmaceuticals in Australia, for its potential to combat melanoma, the most lethal form of skin cancer. Early laboratory studies have revealed that PHEC-66 can halt the proliferation of melanoma cells by inducing programmed cell death or apoptosis. “The damage to the melanoma cell prevents it from dividing into new cells and instead begins a programmed cell death,” says biomedical scientist Nazim Nassar from Charles Darwin University (CDU).

This promising discovery builds on a foundation of cannabis research that suggests certain cannabis compounds can target cancer cells without harming normal cells. Previous studies have shown the potential of cannabis in killing leukemia cells, and research in the US and Italy has found similar effects in non-melanoma skin cancer cells and pancreatic cancer. The recent findings on melanoma add to the growing body of evidence supporting the anticancer potential of cannabis extracts.

These results, however, are preliminary and confined to laboratory studies. “This is a growing area of important research because we need to understand cannabis extracts as much as possible, especially their potential to function as anticancer agents,” Nazar emphasized in Science Alert, highlighting the need for further studies to refine treatment techniques.

Further research, including animal studies, is necessary to determine the applicability of these findings to living organisms and to establish effective application methods and dosages. Only after these steps can clinical trials on humans be considered. With hundreds of cannabinoid compounds in the cannabis plant and their medicinal potential largely unexplored, the research on PHEC-66 represents a hopeful avenue for developing new treatments for challenging diseases like melanoma.⁽³⁾

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New Mexico Advances Psilocybin Research and Therapy Initiative

As covered by Marijuana Moment, a New Mexico Senate committee has unanimously passed a bipartisan resolution aimed at exploring the therapeutic potential of psilocybin, the psychoactive substance found in “magic mushrooms.” Spearheaded by Senate Minority Whip Craig Brandt (R) and Sen. Jeff Steinborn (D), the resolution seeks to engage the state Department of Health in researching the effectiveness of psilocybin for therapeutic treatments and contemplating the establishment of a psilocybin therapy program. This initiative, although not legally binding, signals a significant step toward formalizing the state’s interest in the medicinal benefits of psychedelics.

The proposal underscores a cooperative effort between political lines to enhance therapeutic options for New Mexico’s residents, reflecting a broader national trend of increased interest in the potential mental health benefits of psychedelics. The resolution positions New Mexico as an aspiring leader in psychedelic studies by suggesting a research partnership with the University of New Mexico Health Sciences Center. The bipartisan support for this measure illustrates a shared recognition of the urgency to address widespread mental health concerns with innovative treatments.

Across the United States, states are progressively pursuing legislation focused on the research and therapeutic application of psychedelics, with New Mexico’s resolution adding to the growing momentum. Legislative efforts in various states, including Alaska, California, and Arizona, aim to create regulatory frameworks for the supervised therapeutic use of substances like psilocybin, MDMA, mescaline, and DMT. These initiatives highlight a nationwide shift toward considering psychedelics as viable options for mental health treatment, underpinning the importance of state-level research and policy development.

The unanimous approval of the resolution by the New Mexico Senate committee not only demonstrates a bipartisan agreement on the potential of psychedelics but also aligns with actions taken by other states to reevaluate the role of these substances in therapeutic settings. As research continues to support the therapeutic benefits of psilocybin for conditions such as major depression and substance use disorder, the initiative by New Mexico could pave the way for the development of a state-level psilocybin program, enhancing access to alternative treatments for those in need.⁽⁴⁾

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Sources

Sources

1. Busby, M. (2024, February 14). Israeli Group to Study MDMA Therapy for October 7 Survivors With PTSD. The Intercept. https://theintercept.com/2024/02/14/gaza-israel-mdma-ptsd-study/

2. Jaeger, K. (2024, February 12). FDA Grants Priority Review Of MDMA-Assisted Therapy For PTSD, Psychedelics Drug Development Company Says. Marijuana Moment. https://www.marijuanamoment.net/fda-grants-priority-review-of-mdma-assisted-therapy-for-ptsd-psychedelics-drug-development-company-says/

3. Cassella, C. (2024, February 14). Cannabis Extract Triggers Death of Deadly Skin Cancer Cells. ScienceAlert. https://www.sciencealert.com/cannabis-extract-triggers-death-of-deadly-skin-cancer-cells

4. Walker, D. (2024, February 12). Lykos Therapeutics Highlights the Not-For-Profit to For-Profit Pipeline in Psychedelics. DoubleBlind Mag. https://doubleblindmag.com/lykos-therapeutics-maps/

5. Jaeger, K. (2024, February 13). New Mexico Senate Committee Unanimously Approves Psilocybin Therapy And Research Resolution. Marijuana Moment. https://www.marijuanamoment.net/new-mexico-senate-committee-unanimously-approves-psilocybin-therapy-and-research-resolution/