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.

As a CRO specialising in psychedelics, we're currently engaged in nine trials encompassing a variety of drugs and therapy modalities, ranging from intensive therapy sessions to minimal psychological support. Broadly, these trials fall into two approaches: one aims to maximise efficacy by integrating therapy with the drug, while the other seeks to isolate the drug's effects by minimising therapy. Through these trials, we can discern what approaches yield favourable results and which do not.