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Andrew has been closely following the efforts of organizations like MAPS (Multidisciplinary Association for Psychedelic Studies) and Lykos Therapeutics as they pioneer the use of MDMA-assisted therapy for treating PTSD. Recently, the FDA delivered a surprising and disappointing decision, declining to approve MDMA-assisted therapy despite promising clinical data and asking the company to conduct an additional Phase 3 Study. This ruling has sent shockwaves through the field of psychedelic medicine, especially for those who had high hopes that MDMA would become the first federally regulated psychedelic treatment.
In our conversation today, Andrew will share his insights on the FDA's decision, the implications for Lykos Therapeutics, and what this means for the future of psychedelic therapies. We’ll delve into the challenges faced by Lykos, including the FDA’s request for an additional clinical trial, which could add years and significant costs to the approval process. We’ll also explore the broader context of this decision—how it affects the momentum of the psychedelic medicine movement, the reaction from supporters and critics alike, and the potential shifts in strategy as the industry continues to navigate regulatory hurdles.
For those interested in the intersection of health, science, and business, this discussion promises to be both timely and insightful. So, without further ado, let’s dive into our conversation with Andrew Jacobs.
Link to Andrew's New York Times bio: https://www.nytimes.com/by/andrew-jacobs
Social Media:
X: @AndrewJacobsNYT
Other Links/Mentions:
F.D.A. Declines to Approve MDMA Therapy, Seeking More Study
What Is MDMA Therapy and What Are Its Risks?
A Psychedelics Reporter With a Changing Perspective
Show Credits:
This episode was hosted by Lewis Goldberg and Anne Donohoe of KCSA Strategic Communications. Special thanks to our Program Director, Shea Gunther.
You can learn more about how KCSA can help your cannabis and psychedelic companies by visiting www.kcsa.com or emailing [email protected]. You can also connect with us via our social channels:
X: @KCSAPodcastLabs
Instagram: @KCSAPodcastLabs
LinkedIn: https://www.linkedin.com/company/kcsapodcastlabs/
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