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FDA MDMA rejection ... what's next?

The FDA’s Rejection on MDMA-Assisted Therapy: What is Next for the...

The FDA's call for another phase 3 study of MDMA-Assisted Therapy delays approval, revealing biomedical reductionism, misunderstanding of therapeutic roles, and social prejudices against psychedelics. Despite setbacks, research continues to influence drug reform and public perception. Chacruna remains committed to safeguarding plant medicines, advocating for marginalized voices, and fostering cultural and scientific integration in the psychedelic movement.
MDMA FDA APPROVAL

Will MDMA win FDA Approval?

Recent advisory groups ICER and AdComm have recommended against FDA approval of MDMA for medical use, citing questionable efficacy and safety concerns in treating PTSD. This unexpected stance disrupted the anticipated swift approval, casting doubt on the potential of MDMA-assisted psychotherapy. Criticisms include methodological flaws, conflicts of interest, and reported ethical violations in trials. As the FDA decision nears, stakeholders are grappling with the mixed opinions, regulatory hurdles, and future of psychedelic medicine. Further research and rigorous oversight remain imperative.
psymposia MDMA MAPS

The Unbelievable Claims of Psymposia about MAPS and MDMA-Assisted Therapy

Geoff Bathje, initially supportive of Psymposia’s critiques within the psychedelic field, has grown skeptical of their recent approach. Bathje argues that Psymposia’s criticism of MAPS and Lykos lacks nuance and may perpetuate stigma and hinder drug policy reform. He believes Psymposia’s tactics and rigid views could harm efforts for a balanced, inclusive approach to psychedelic therapy.
FDA votes against MDMA assisted therapy

Psychedelic Assisted Therapy with MDMA Stumbles Over Pharmacological Dogma

On June 4, an FDA advisory committee overwhelmingly rejected MDMA-assisted therapy for PTSD, citing inadequate evidence and concerns over therapeutic methods. Despite this setback for Lykos Therapeutics, hope remains for conditional FDA approval in August. The outcome could significantly influence the integration of psychedelics into psychiatric treatment paradigms.
Scenes from Psychedelic Cultures 2024

The Perfect Flower of Psychedelic Culture: Chacruna Institute’s Conference Proposes Combining...

Marcelo Leite reflects on his experience at Chacruna's Psychedelic Culture 2024 conference in San Francisco. He notes the conference's goal to combine psychedelic science and Indigenous knowledge and highlights some of the notable moments at the event.
Ken Jordan, co-founder of Lucid News

Lucid News Co-Founder, Ken Jordan, Has Died

Lucid News co-founder, Ken Jordan, passed away on Sunday, May 12, 2024. Jordan was a leader in the psychedelic movement and passionately believed in the importance of accurate and accessible information about psychedelics.
Therapists, Trainers, and Researchers from Lykos’ Phase 3 MDMA-Assisted Therapy Studies Respond to Concerns in ICER’s Draft Evidence Report

Therapists, Trainers, and Researchers from Lykos’ Phase 3 MDMA-Assisted Therapy Studies...

The Institute for Clinical and Economic Review (ICER), is an independent non-profit research organization that evaluates the evidence on the clinical and economic value of prescription drugs, medical tests, devices, and health system delivery innovations.
Industry is trepid about psychedelics markets going into 2024.

2024 Begins with Trepidation in Psychedelic Medicine and Markets

In this article, Marcelo Leite outlines the major developments in psychedelic science and markets going into 2024 that are causing industry trepidation. The biggest news of January comes from MAPS and its business division, which has been rebranded as Lykos Therapeutics.
Chacruna Files Amicus Brief in Support of Iowaska Church of Healing

Chacruna Institute Files Amicus Brief in Support of Sacramental Churches’ Rights...

The Chacruna Institute and Sacred Plant Alliance filed this amicus brief on October 17, 2023 in support of the plaintiff church in the Iowaska Church of Healing v. United States case, to emphasize to the U.S. Court of Appeals for the D.C. Circuit why the decision in the lower court, the district court, was wrongly decided.
United Nations on Psychedelics. The World Drug Report 2023 and the Renewed Interest in Psychotropics Substances

United Nations on Psychedelics. The World Drug Report 2023 and the...

The United Nations has played a significant historical role in the control of psychedelic drugs worldwide. 2023's World Drug Report marks a renewed interest in psychotropic substances on the part of the international governing body.
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