This special issue of Neuropharmacology provides a comprehensive update on basic and clinical research on psychedelics since 2018, partly based on the NIH Psilocybin Research Speaker Series held from April to June 2021. The FDA has granted breakthrough therapy designations for psilocybin in treatment-resistant depression (2018) and major depressive disorder (2019), and for MDMA in post-traumatic stress disorder (2017). Clinical trials are ongoing for psilocybin in depression, cancer-related anxiety and depression, anorexia, PTSD, substance use disorders, and chronic pain. The collection aims to support the transition of psychedelics from bench to mainstream therapies, with global implications following potential FDA approvals.
Psychedelic and entactogen medicines like psilocybin and MDMA, when combined with psychosocial support, show potential for safe, rapid, and durable clinical improvements. Both have received Breakthrough Therapy designation from the US FDA and may gain full approval, with similar regulatory steps in other countries. Regulatory changes are also increasing access to legal or decriminalized psychedelic use outside medical settings. This review covers historical use, current evidence, and policy considerations around standards of practice, consumer protection, community engagement, equitable access, and data standards. It suggests a public-private partnership involving diverse stakeholders to co-create best practices and public policies supporting responsible, ethical use.