Expert: MDMA Is Very Likely to Be FDA-Approved for PTSD by the End of 2023

Pharmacy Times interviewed Kelan Thomas, PharmD, MS, associate professor of clinical sciences at Touro University California College of Pharmacy, on his recent presentations at Insight 2021 and the virtual Sana Symposium on psychedelic adverse effects and drug-drug interactions.

Alana Hippensteele: At Insight 2021 and the virtual Sana Symposium, were there any common themes or key points you observed being raised of note in the field?

Kelan Thomas: Yeah, so I think the common themes that I'm seeing is people are starting to think about best practices. There's a lot of influence from psychology, so the biggest difference with these drugs is that these are in combination with psychotherapy, particularly MDMA and psilocybin; ketamine has a little bit of both.

So, the clinical trials for esketamine (Spravato; Janssen Pharmaceutical) approval had no psychotherapy component, but a lot of clinics are seeing a benefit when they add psychotherapy to sort of the days after it sort of loosens people's rumination and these fixed beliefs and it allows this reopening of social learning.

If we think of psychiatric disorders as a loss of connection to other people, relationships, etc, using it as a way to think of new patterns of behavior, there's a lot of themes around that of seeing these as a way to shift and modify new behaviors that are more adaptive and provide more resilience against anxiety, depression, substance use disorders.

So that's the major theme that I'm seeing is this whole new paradigm of adding psychotherapy comes with a lot more complexity than just a simple drug approval like just take the drug and you'll get the result. This has this added aspect of psychotherapy, and that's a whole very new concept in terms of the drug approval process is having studies that are looking at drug plus psychotherapy.

Alana Hippensteele: Do you think that might have an impact on the approach for other psychiatric medications that are maybe already approved or will be in the future, just in terms of this new approach?

Kelan Thomas: Yeah, I think this idea and this paradigm of showing these large effect sizes in terms of how effective they are—it does raise a reappraisal of: Are we optimizing psychotherapy, are we doing these other things that clearly have benefit?

There's certainly trials of mild cases of depression, mild anxiety where things like cognitive behavioral therapy or cognitive processing therapy in PTSD can have similar benefits to medication. So really thinking about how do we optimize and use both medication and psychotherapy to get the best health outcomes, I hope that that's a broader implication of this emerging research is that it allows mental health care systems to integrate and think about optimizing mental health through group therapy structures, working with one-on-one individual psychotherapy, all these other ways that we can promote mental health and resilience. I hope people will do more of that.

Alana Hippensteele: Right absolutely. Any closing thoughts?

Kelan Thomas: So the greatest update now, COVID-19 delayed a lot of clinical trials in the past year or 2, especially things that weren't related to treating COVID-19, but it seems like by about the end of 2023, MDMA is very likely to become FDA-approved for PTSD, and psilocybin will likely get approved for depression in the following year or so after that.

So, I would encourage pharmacists to start reading the literature, start looking at these articles and evaluating this because these things are coming soon, and they are quite different than the way that we've thought about other new therapeutics on the market. So, I think it's important for pharmacists to start thinking about what their role could be to facilitate this transition into a new paradigm of psychiatric treatment.

Alana Hippensteele: Right, absolutely on that potentially also a new opportunity for pharmacists to collaborate with psychiatrists or people in the field who maybe they wouldn't have had that close contact or close communication with just based on what you're talking about the psychotherapy component, which is fascinating.

Kelan Thomas: Yeah, I hope that it promotes more of an interdisciplinary team and multimodal approach which I think you always get the best outcomes the more ways you're trying to solve a problem in a team-based care approach.