The FDA continues to signal openness to psychedelic-based therapies. Following its recent Breakthrough Therapy Designation (BTD) for a potential LSD-based anxiety treatment, the agency has extended the same status to Cybin Inc.‘s CYB003 for major depressive disorder (MDD). The move marks the first FDA Breakthrough Therapy Designation for an adjunctive, psychedelic-based Major Depressive Disorder treatment.…
Psychedelic therapy at a crossroads at the dawn of 2023
In several ways, psychedelic therapy continued to make strides toward legitimization in 2022. Michael Pollan’s best-selling psychedelic treatise “How to Change Your Mind” formed the basis for a popular Netflix series. Several celebrities declared that psychedelics had improved their lives. Decriminalization efforts gaining steam Colorado decriminalized psychedelic plants, as did the city of San Francisco.…
What is the role of preparation and integration in psychedelic therapy?
The organizations that have made the most progress in the clinical development of psychedelic agents — broadly defined — have tended to prioritize psychological support before and after drug administration. A position statement from the the American Psychiatric Association notes that, in preliminary research, psychedelics “have generally been combined with structured psychotherapy protocols proposed by…