Officials with the Food and Drug Administration (FDA) recently joined scientists at a public meeting on next steps for conducting research to develop psychedelic medicines.
During the two-day event hosted by the Reagan-Udall Foundation earlier this month, multiple FDA representatives discussed the agency’s work to promote clinical trials into the therapeutic potential of substances such as psilocybin and MDMA. Academics and psychedelics drug development professionals also participated in the sessions.
This comes months after FDA issued historic draft guidance on psychedelics studies, providing scientists with a framework to carry out research that could lead to the development of novel medicines.
Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research (CDER), delivered opening remarks during the first day, stating that while psychedelic medicines have not yet been approved for medical use, “we certainly recognize that there has been growing interest in the therapeutic potential of psychedelic drugs in recent years.”
“Psychedelics are being evaluated for use in the potential treatment of a number of conditions including depression, post-traumatic stress disorder and substance use disorder,” she said. “We also recognize that in the real world, many people are currently using psychedelics outside of clinical trials.”
“Given these realities, this workshop is an important opportunity to expand our knowledge about psychedelic clinical trial design, as well as to explore considerations for current use of psychedelics and potential future use of psychedelic drugs,” Cavazzoni said. “In the event that a psychedelic drug is approved as safe and effective, this type of exploratory conversation on potential future use will help prepare our key partners and the patients they serve for what comes next.”
Tiffany Farchione, who works in FDA’s division of psychiatry, gave an overview of the agency’s psychedelics clinical trials guidance.
“There’s a lot of excitement about the potential for psychedelics to transform the treatment of psychiatric and substance use disorders, or even just to improve overall wellbeing,” Farchione said, pointing a slide of recent news headlines including Marijuana Moment’s coverage of a California psychedelics bill. “And the general tenor of all of these articles tends to be one of inevitability. But you know, as anybody who’s ever heard me talk about psychedelics before knows, this is this is putting the cart before the horse from a treatment perspective.”
During the second-day event, Farchione also spoke on a panel titled “Overview of FDA Regulatory Authority,” where she explained the complications of assessing the effectiveness of drugs that require interventions outside of their direct administration. In the context of psychedelics, this complicating factor comes to play with the notion that the substances should be coupled with psychotherapy, for example.
“For us to be able to fully tease out the safety and efficacy contributions of psychotherapy in psychedelic trials, we would need well-done factorial studies. But these are big and expensive, and there’s an argument that if you don’t have the therapy that that’s unethical or problematic in some way,” she said. “We don’t actually know. I think that a factorial study would be highly informative and allow us to write a better label, but we just haven’t seen that done. So, for now, what we have is an assumption that the psychotherapy is necessary—but that assumption hasn’t been rigorously evaluated.”
Javier Muniz, another FDA official, similarly weighed in on the complexities of psychedelic drug approvals in a panel that examined the concept of “set and setting” for the unique therapeutics.
“I appreciate all the discussions that’s going on here, but I’m going to try to bring it back a little bit to us as regulators. At the end, and in the context of drug development, what is set and setting and how is that an important thing?” he said. “To me, at least, this issue of set and setting is very closely intertwined with the same issues that we see with the psychotherapeutic component.”
“In contrast to most drugs, we usually don’t pay any attention in a clinical trial in terms of where and how is the patient taking the drug,” he said. But for psychedelics, there has been a focus on how “the way this context is experienced is highly influenced by cultural and personal influences.”
“The problem for us as regulators is, well, it’s highly variable and also there’s a lack of a rigorous definition of what exactly is this set and setting,” Muniz said.
“We usually do not make a big deal about that. It is just not something that’s variable. Here, it’s a completely different approach where we have these preparatory sessions. We have in-treatment sessions, and then we have the post-integrative sessions. So this is an integral part of the psychotherapeutic experience with psychedelics. And how to tease that apart? And if you ask me, again, what is our priority? I think those well-done factorial studies are absolutely critical to understanding what those contributions are.”
Another panel during the first-day event featured international researchers, as well as FDA’s Bernard Fischer, who continued the conversation on how to most effectively carry out research into plant-based medicines, focusing on study designs and control conditions.
In the background, FDA recently accepted an application to review MDMA-assisted therapy as treatment option for post-traumatic stress disorder (PTSD), agreeing to carry out the analysis on an expedited basis.
The new drug application was submitted by Lykos Therapeutics (formerly MAPS Public Benefit Corporation). The chief scientific officer of Lykos separately participated in a panel at the Reagan-Udall Foundation event this month, alongside representatives of the psychedelics-focused research companies Compass Pathways and MindMed.
They served as speakers on the panel, which centered on dosing with entheogenic substances. The respondents were researchers at the University of Alabama, University of California, San Francisco and FDA’s Martine Solages.
FDA isn’t the only agency that’s looking into psychedelics research. For example, under the 2024 National Defense Authorization Act (NDAA) that President Joe Biden signed into law late last year, the Department of Defense (DOD) will be required to use $10 million in funding to study the therapeutic potential of psilocybin, MDMA, ibogaine and 5-MeO-DMT for the treatment of certain mental health conditions.
In another major milestone on the path to expanding access to psychedelic-assisted therapy among the nation’s military veterans, the Department of Veterans Affairs (VA) recently issued a request for applications to conduct in-depth research on the use of psychedelics to treat PTSD and depression.
Photo elements courtesy of carlosemmaskype and Apollo.
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