What Can be Learned From the FDA Advisory Panel’s Meeting on MDMA?


Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, discusses how some of the concern’s raised by the panel can inform future psychedelic research.

The recent meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee wherein the panel voted against the use of MDMA to treat PTSD was a significant setback for proponents in the field of psychedelic medicine. The meeting was the first to review a psychedelic-assisted therapy in the United States, representing a historic moment for psychedelics.

During the meeting, panel members raised various concerns about 2 phase 3 studies used to support the new drug application from Lykos Therapeutics. Of the issues discussed, functional unblinding, safety data, and the potential for abuse were cited as key problems. The panel members also said that a case of documented patient abuse, which occurred in an earlier phase 2 trial, made it difficult to support a vote in favor of the treatment.

READ MORE: Discussing the FDA Panel’s Rejection of MDMA-Assisted Therapy for PTSD

Moving forward, how can psychedelic researchers take the panel’s criticisms and improve on future clinical trials?

Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, said that the panel did raise good points. In an interview with Drug Topics, Clark discussed how the different issues brought up by the panel can be resolved and why he think’s MDMA is approvable given the unmet need in patients with PTSD.

“I believe MDMA can be rolled out safely with a very strict REMS program,” Clark said. “You can add a lot of things to that REMS program. You can make sure how well the drug is tracked so that there is no potential for diversion. You can add in a number of requirements on therapists [and] that both therapists must be licensed instead of just 1. Therapy can be recorded. You can add many levels of restriction to make sure that abuse doesn’t occur and that drugs don’t get diverted. And the potential safety issues associated with MDMA can be followed up in post market surveillance.”


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