The FDA’s recent decision to reject MDMA-assisted therapy for market approval is undoubtedly disappointing, but not entirely surprising. This therapy, disruptive in both regulatory and clinical delivery perspectives, faced a rigorous review process, serving as a reality check for the challenges involved in approving groundbreaking drugs. Yet, this moment represents a crucial opportunity for the sector, one that will ultimately enhance research practices and advance scientific understanding.

Despite the widely recognised need for PTSD treatments and inspiring patient stories supporting MDMA-assisted therapy, an overwhelming majority of the FDA’s Advisory Committee found the efficacy data unsatisfactory and concluded that the benefits didn't outweigh the risks due to methodological and misconduct issues. Although the panel's rejection doesn't guarantee the FDA will disapprove this treatment, it clearly highlights what regulators will scrutinise when evaluating psychedelic therapies. For Lykos, the decision was disappointing, but for others, it has provided invaluable insights into what will be needed to bring psychedelic treatments to market. This article distils the key actionable lessons on designing and delivering psychedelic trials to meet regulatory standards.