As the first psychedelics near approval, several other factors warrant attention to ensure effective and safe implementation.

The cost and logistical complexities of delivering psychedelic-assisted therapy pose challenges for healthcare systems. Photo by: Yarphoto / iStock / Getty Images Plus via Getty Images.

Following decades of stagnant research, psychedelic-assisted therapy has been heralded as a potentially transformative approach amid a global mental health crisis.

According to World Health Organization (WHO) data published in August 2025, over one billion people live with mental health conditions worldwide. Despite substantial investment, psychedelic research has seen several setbacks. Most notably, the rejection of the MDMA (3,4-methyl​enedioxy​methamphetamine)-based therapy by Lykos Therapeutics, now known as Resilient Pharmaceuticals, by the FDA in 2024 exposed the inherent challenges psychedelic research faces, including the risk of functional unblinding and the difficulty in determining efficacy independent of psychotherapeutic support. Discover B2B Marketing That Performs

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