Today, the FDA shared the rejection letter for Lykos Therapeutics’ MDMA therapy application alongside several other controversial drug decisions.
I’ve been tracking this issue for quite some time as I’ve been quite impressed with the efficacy and safety data on psychedelic therapy for treating mental health disorders such as treatment-resistant depression, smoking addiction, PTSD, and more. I’ve also tried MDMA therapy myself, including quite recently, and written about it at length.
Last year, I did two podcasts with Dr. Matt Johnson in response to the FDA’s advisory panel on MDMA therapy and the eventual rejection. Today, Matt and I examine the FDA’s stated reasons in the official letter sent to Lykos about safety and efficacy. Dr. Matt Johnson is one of the most esteemed psychedelic researchers on the planet and is a fairly sober-minded, rational thinker in the space (not always a given in this field) so I brought him back on to discuss the letter.
In summary: we’re not impressed with their reasons. We go through them step-by-step and examine their rationale.
Enjoy this episode paywalled for 24-48 hours (free 5 min preview) until we get the full edited version up on all platforms
