“Whiz” Buckley Explains Why FDA Rejected MDMA For PTSD
Looking at psychedelics in our latest Trade To Black podcast, Life Science Investor and Military Veteran Matthew “Whiz” Buckley, joins us again to shed light on the reasons behind the Food and Drug Administration’s (FDA) decision to decline approval of using MDMA as a treatment for PTSD last month. Whiz Buckley is a well-known psychedelic investor and also the founder of No Fallen Heroes, a support to the veteran community.
Lykos Therapeutics, formerly known to many as MAPS PBC, had submitted a new drug application (NDA) application to use midomafetamine (MDMA) capsules in conjunction with therapy as a novel treatment of post-traumatic stress disorder (PTSD) in adults. The application had been accepted for review by the FDA in February of this year. The response from the FDA came in August that more trial data is required before approval can be granted, and they requested that Lykos perform an additional phase 3 trial.
It was a devastating setback for proponents of psychedelic assisted therapy, as no other company is close to seeking approval for MDMA. And in the wake of the decision, Lykos announced major restructuring efforts to advance PTSD research and treatment.
In our discussion, we touch on various issues, including the trial’s design, execution, and the choice of MDMA as the first primary compound for FDA submission, rather than plant-based compounds like Ibogaine and others. Lykos’ trial garnered bipartisan support from 80 congressional members advocating for further studies on MDMA-assisted therapy for PTSD to accelerate access to treatment for veterans grappling with increasing suicide rates.
With the FDA determining that they require additional data, many investors in the industry are pondering what comes next in the short term. Was this response to be expected, and is it possible that Ibogaine would be more likely to become an accepted treatment, since it lacks the stigma of MDMA? It’s an interesting conversation that sheds light on what went wrong, and the lessons Lykos Therapeutics will be able to learn from it.
