In early December, our Editor Josh Hardman sat down with Javier Muniz, MD, who had recently left his post as Associate Director at the FDA’s Division of Psychiatry. There, he was at the heart of the agency’s psychedelics learning journey and helped formulate its view on thorny topics in psychedelic drug development like functional unblinding and the role of psychotherapy.
The interview was far-reaching, beginning on topics like FDA’s psychedelics-related trip of discovery, which includes Michael Pollan’s best-selling book but also standing-room-only presentations at conferences, before diving into some of the specific challenges that psychedelic drug developers face and how Muniz, and the FDA, might think about them. Those include managing functional unblinding, demonstrating durability of effect, understanding the role of psychotherapy, and more. We also had Muniz weigh in on whether the agency has a higher bar for psychedelic programmes, if he thinks Janssen’s esketamine nasal spray (Spravato) would be approved today, and why Lykos Therapeutics’ MDMA-assisted therapy new drug application (NDA) was not approved earlier this year.
Aside from these more regulatory-minded topics, we also discuss Muniz’s views on mystical experiences (and whether their intensity makes attempts to blind psychedelics studies futile), decriminalisation and legalisation efforts, what the incoming Trump administration might mean for the field, and much more.
The interview is extensive, and our longest one yet at well over 7,000 words.
Read: Pα+ Inside the FDA’s Psychedelics Journey: Javier Muniz, MD on Breakthroughs, Challenges, and the Future of the Field (December 5, 2024).