Q&A: How Will the FDA Panel's Decision on MDMA Impact the Future of Psychedelic Medicine?

The FDA’s Psychopharmacologic Drugs Advisory Committee voted against the use of MDMA to treat PTSD earlier this month, giving proponents of psychedelic treatments a disappointing setback. The panel, which raised various concerns about a new drug application from Lykos Therapeutics, was the first to review a psychedelic-assisted therapy in the United States. The panel’s decision has left many wondering what the future of psychedelic medicine now looks like.

How Will the FDA Panel's Decision on MDMA Impact the Future of Psychedelic Medicine? / CravenA - stock.adobe.com

Drug Topics sat down with Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, to discuss how the FDA advisory panel’s decision could impact the future of psychedelic medicine, if the decision could cause some health care professionals to view psychedelics negatively, and what the future looks like for psychedelic treatments.

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

Drug Topics: How do you think the FDA advisory panel’s decision on MDMA will impact the future of psychedelic medicine and do you think it could cause some health care professionals to have a negative view of psychedelics?

Sam Clark, MD, PhD: I think it will cause some delays, but it really depends on if the FDA approves MDMA or not in August. They don't have to listen to the panel decision, and it's possible that, based on the knowledge and the data they have from the Lykos submission, that they still approve it, although the chance is a lot lower, but it still might happen.

Now, the thing is that, how does it affect the field of psychedelics? Well, there were some panel recommendations that were good. The multiple dose arms and the need for safety labs and careful monitoring to prevent patient abuse, these are all critical things, and we hope that every psychedelic company developing psychedelics takes that into serious consideration and implements those, as that will improve on any deficiencies from the Lykos NDA package for future submissions, making it a bit easier.

However, will this [decision] potentially dissuade people? That gets back to [another] issue, which is at the panel, we saw harmful stereotypes of psychedelics as gateway drugs repeated. The idea that this would lead to left and right diversion to the black market, that it would be everywhere outside the clinic, and the statement that it would lead people to go home after the session and take alcohol and cocaine, repeats those harmful stereotypes and could lead to doctors, who don't know the data, assuming that those statements were backed up by some sort of research study, when in reality, they were not.

Drug Topics: Is there anything else that you wanted to add about the future of psychedelic medicine?

Clark: I think that psychedelics have a lot of promise. We've seen that with multiple phase 2 trials. We've seen phase 2 trials of LSD show amazing promise for anxiety without therapy at all. We've seen trials with psilocybin with only minimal assisted psychological support show great promise for treatment resistant depression, and it may have promise as well for PTSD. Although the trials are small, we've seen 5-MeO-DMT showing effects as well for depression. The mechanism is novel for these psychedelics, the effects seem to be rapid and patients really need access to these compounds.

We also have to remember that some of these compounds have been around for thousands of years and have been used by people before for medicinal purposes. Psilocybin mushrooms been around since as long as humans have been around. 5-MeO-DMT is also a thousands of year old compound. DMT itself from the plant, that's also a very old compound. In that sense, it's only recently that we're catching up in research. These drugs were incorrectly listed as having no medicinal purpose despite thousands of years of human use, and now we're seeing the potential for them being reexamined. The data is supportive, and patients desperately need treatments.

So, I think the future is bright. Issues the panel brought up can be addressed by other companies proactively. But I want to go on the record in that we hope this will not derail the immediate approval of MDMA for post-traumatic stress disorder. The effect size was massive in these trials, the patients were extremely sick going into these trials, and patients of that kind need therapies without delay. A treatment delayed is a treatment denied and we need to get new treatments to patients, quickly.

READ MORE: Mental and Behavioral Health Resource Center

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