Welcome back to The Trip Report Podcast, a production of Beckley Waves, a Psychedelic Venture Studio.
Today, I am speaking with Rick Doblin, founder and President of the Multidisciplinary Association for Psychedelic Studies (MAPS).
December of last year was a milestone for Doblin and MAPS, as the organization submitted a New Drug Application for MDMA Assisted Therapy to the United States Food and Drug Administration.
Then, in the first week of January, the MAPS Public Benefit Corp announced its rebranding to Lykos Therapeutics and a $100 million Series A financing.
Needless to say, it has been a pivotal period in the organization’s history and a watershed moment for the revival of psychedelic medicine, science, and policy.
In February, the FDA accepted the application and granted a priority review, putting the decision timeline at August of this year.
That’s just around the corner.
And so much is still up in the air—of course the big question—will the FDA grant approval?
But also so many granular details that will have significant downstream effects on the commercial rollout, access, and cost.
What language will be on the drug label?
What will the Risk Evaluation and Mitigation Strategy entail?
How will patients be able to access the drug?
What will the FDA say about the role of therapy?
Among others.
So, I wanted to sit down with Rick to talk about it and get his perspective on the organization’s evolution, the path ahead, and, most importantly, the many uncertainties that hang in the balance.
In this conversation, we discuss:
The importance of therapy in conjunction with MDMA (and his loathing of the acronym MDMA-AT)
The many regulatory and bureaucratic details that go into the FDA’s decision and subsequent commercial rollout, including:
Drug labeling
Therapist credentialing
Risk Evaluation and Mitigation Strategies
The negotiations he’s led with the FDA over the last 20 years
Lykos’ goal of getting MDMA-Assisted Therapy FDA approved and MAPS’ goal of getting MDMA federally legalized
The role of therapist’s first-hand experience with MDMA and the regulatory battle of ensuring legal access to this group
His future humanitarian and scientific plans
And much more.
And now I bring you my conversation with Rick Doblin.
Listen to the episode on Substack, Spotify, Google or Apple.
Credits:
Hosted by Zach Haigney
Produced by Zach Haigney, Erin Greenhouse, and Katelin Jabbari
Find us at thetripreport.com
Theme music by MANCHO Sounds, Mixed and Mastered by Rollin Weary
#18 Rick Doblin: The Path to MDMA Approval and Beyond