In our latest interview, Psychedelic Alpha’s Josh Hardman speaks with Javier Muniz, MD, who recently left his post as Associate Director at the FDA’s Division of Psychiatry. In that role, Muniz 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.
Muniz has been on our radar for quite some time as a leader within the agency on the topic of psychedelics, so we were pleased to speak with him now that he is able to discuss these matters more candidly. Since leaving the agency, Muniz has begun offering consultancy services via his firm PsyNova Solutions, and shortly after we conducted this interview he was appointed as VP of R&D at psychedelic drug developer MindMed. He very much intends, then, to continue engaging with the psychedelics field.
The interview itself is far-reaching. We begin by discussing the FDA’s psychedelics-related trip of discovery, which includes Michael Pollan’s best-selling book but also standing-room-only presentations at conferences and internal symposia that saw the agency bring in leading psychedelics researchers.
We then dive 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.
As you might have guessed, this interview is extensive. It’s our longest one yet at well over 7,000 words, so we have used subheadings, sometimes awkwardly, to help you navigate the discussion.
Without further ado, please enjoy Josh’s interview with Javier Muniz, MD…
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In this Interview
- Muniz’s Background, Initial Interest in Psychedelics
- The Weight and Responsibility Associated with FDA Approvals
- Stoking Early Interest in Psychedelics at the FDA
- Early Discussions with Psychedelic Drug Developers, Esketamine’s Precedent, and Engaging with the Field
- FDA’s Internal Psychedelics Symposia, Guidance
- Would Spravato Be Approved Today? Debate Over Durability of Effect
- Does the FDA Have A Higher Bar for Psychedelics?
- Psychotherapy in Psychedelic Trials
- MAPS/Lykos Therapeutics’ ‘Bold’ Approach to Psychotherapy
- The Upshot for Sponsors: Minimise or Characterise Psychotherapy? (Or, Simplify the Story?)
- Non-Study Psychotherapy; The Role of Mystical Experiences
- Are Attempts to Blind Psychedelic Trials Futile?
- Why Did Lykos’ NDA Fail?
- Will a New U.S. Government Catalyse Psychedelic Drug Development?
- Views on Decriminalisation and Legalisation
- Comps for Psychedelic Drug Development
- Motivations for Continuing to Work in Psychedelics
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Muniz’s Background, Initial Interest in Psychedelics
Josh Hardman, Psychedelic Alpha: Could you briefly sum up your interactions with psychedelic drug development at the agency?
Javier Muniz, MD: All my life has been a series of fortunate accidents. I ended up at the FDA about 11 years ago, starting in addiction and pain drugs. I loved it. I used to be a clinician in the military and taught psychopharmacology at the Uniformed Services University of the Health Sciences and Walter Reed. I had one student tell me: ‘You would be great at the FDA’ and I thought that it could be a great fit for me. When I got this job at the agency I thought it was amazing… people were paying me to learn stuff!
Then a friend of mine recruited me into the Division of Psychiatry because they were having significant turnover. Within a couple of months I started showing good work and having leadership potential, so they promoted me to Clinical Team Leader.
That’s when some of these psychedelic drugs started coming in more seriously, like MAPS (Lykos Therapeutics now, of course), then Compass Pathways and Usona Institute. I started getting really curious about it.
My initial draw to this field was more of an intellectual curiosity for trial design. I tend to immerse myself in reading whatever captures my interest, and when I began exploring the topic of psychedelics, it truly challenged my perspective. Until then, I had viewed psychedelics as relics of the past or simply grouped them with the notion that all drugs are inherently bad. I started exploring psychedelics and saw their potential, but I quickly encountered the issue of dramatic functional unblinding in trials. The key question is: how do we minimise these biases scientifically? So that’s what initially attracted me to this…
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