In this breaking news episode of The Dales Report, we have big news to discuss in the world of psychedelics. Shadd Dales is joined by Numinus (NUMI) CEO, Payton Nyquvest to discuss the Multidisciplinary Association for Psychedelic Studies (MAPS), which has just submitted a new drug application (NDA) to the Food and Drug Administration.
In a huge stride towards revolutionizing mental health treatment with new therapy models, the MAPS Public Benefit Corporation (PBC) has submitted NDA to the FDA. The NDA submission is for a combination of psychological intervention and MDMA administered in the form of capsules for the treatment of PTSD.
This is great news not just for MAPS, but for the industry as a whole. Payton calls it “the biggest catalyst that we’ve seen in the space yet.” Psychedelic-assisted psychotherapy has been showing some intriguing possibilities, although the drug remains unauthorized by any regulatory agency, and safety and efficacy of psychedelic-assisted psychotherapy has not yet been firmly established by these early clinical trials.
Payton and Shadd discuss the significance and implications of this submission by MAPS to the FDA in detail. With over two decades of dedicated clinical studies, this submission marks not only a milestone for MAPS but also a groundbreaking moment as the first assisted therapy presented to the FDA for approval.
This NDA comes at a time of real need, particularly for veterans who have been struggling with mental health. We explore some of the obstacles that may stand in the way, but things are looking about as favorable as MAPS could hope for in positioning psychedelic assisted psychotherapy for approval. The upcoming election year also is expected to help.
The potential approval of this treatment offers a fresh perspective on mental health, especially in the context of Post-Traumatic Stress Disorder, where optimism is fueled by the drug’s Breakthrough Therapy status and growing cultural momentum.
Be sure to tune in for all of Payton and Shadd’s thoughts on MAPS’ NDA to the FDA.
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