Psychedelic Science 2025: Lessons From MDMA Trials Could Strengthen Future Psychedelic Approvals

At the 2025 Psychedelic Science Conference in Denver, Colorado, the FDA’s advisory committee vote against MDMA-assisted therapy for post-traumatic stress disorder (PTSD) sparked intense debate across the psychedelic medicine community. While pivotal phase 3 trials demonstrated statistically significant reductions in PTSD symptoms with MDMA treatment, the FDA cited concerns about data reliability and trial oversight, ultimately issuing a complete response letter to Lykos Therapeutics in August 2024. This decision followed mounting scrutiny over ethical violations at one trial site, where misconduct by clinical investigators—later confirmed in a journal retraction—cast doubt on the integrity of the broader data set.

In this interview with Pharmacy Times®, Joel Stanley, CEO of Ajna Biosciences, a company developing novel psychedelic compounds, reflects on the regulatory and ethical implications of the MDMA program’s derailment and shares lessons for the next wave of psychedelic trials. He explores how future studies can better meet FDA expectations around blinding, safety, and objectivity, and underscores the need for standardized care models and infrastructure to support safe, multidisciplinary delivery of psychedelic-assisted therapies. Stanley also highlights the critical role pharmacists will play in ensuring clinical readiness and regulatory compliance as the field moves forward.

Pharmacy Times: What were your main takeaways from the discussions around the MDMA phase 3 trial setback at Psychedelic Science 2025?

Joel Stanley is CEO of Ajna Biosciences in Denver, Colorado.

Joel Stanley: The big takeaway is that MDMA showed substantial efficacy for PTSD, but the FDA pushed back because of concerns around trial objectivity, as well as placebo controls, which are difficult for a drug like MDMA. There was a sense that enthusiasm for the therapy may have compromised neutrality. Being the first psychedelic therapy to go this far, MDMA’s program gave the rest of the industry some direction.

For those of us advancing other compounds, especially as we look ahead to phase 2 and 3 trials, we now know how important it is to keep objectivity front and center. Passion around these therapies is natural, but we can’t let it bleed into the science. It's a tough, expensive lesson, but I don't think it’s the end for Lykos Therapeutics and MDMA. It’s still a powerful and promising drug. This is just a step back in an otherwise forward-moving journey.

Pharmacy Times: Following the FDA advisory committee’s vote against MDMA-assisted therapy, how might developers of psychedelic therapies better design future trials to meet FDA expectations around safety, blinding, ethical standards, and long-term outcomes?

Stanley: Designing truly blinded studies with highly psychoactive compounds is extremely difficult—everyone knows if they’ve been given the active drug. I think Lykos Therapeutics did the placebo control about as well as anyone could, and the industry should thank them for pioneering the issue. That said, when we get to our blinded trials, especially with our third and fourth drug candidates that are highly psychoactive, we’ll revisit everything Lykos Therapeutics did with a fine-tooth comb to ask: What would we do differently?

It’s less about fixing one glaring issue and more about learning from every nuance—how enthusiasm was managed, how objectivity was preserved, and how safety and outcomes were framed. The playbook is being written in real time.

Pharmacy Times: What impact do you foresee the MDMA regulatory setback having on other investigational psychedelic compounds currently in the clinical pipeline?

Stanley: The most significant immediate impact is on funding. There’s a public misperception that the MDMA program “failed,” when in reality it’s still in motion. That misunderstanding has made some investors nervous. But I think the FDA response to MDMA sets the stage for future compounds to succeed—because now we all know more about the FDA’s expectations. If anything, the next wave of trials has a better chance of approval because of what we’ve learned here.

Pharmacy Times: With psychedelic drugs often requiring a multidisciplinary care team, how might regulatory guidance beyond the FDA need to evolve to address not just the drug but also the delivery model?

Stanley: That’s a key issue. Right now, the FDA doesn’t regulate therapy protocols, so it’s up to the industry to standardize care. I think we’ll see something similar to how clinical trials evolve, where each new program builds off what the FDA accepted in earlier ones. If a previous therapy model worked and got through review, new trials may follow that boilerplate.

Groups such as Naropa University and Multidisciplinary Association for Psychedelic Studies (MAPS) are already developing training protocols for therapists, and that infrastructure will continue to grow. Whether a formal regulatory mechanism ever emerges to pair drug approval with therapy standards remains to be seen, but some version of that may well be needed in the future.

Pharmacy Times: Are there any emerging regulatory pathways, such as breakthrough therapy designation or regenerative medicine advanced therapy, that you think will be especially important for moving psychedelics forward in the next few years?

Colorful MDMA pills. Image Credit: © Sean - stock.adobe.com

Stanley: We’ve already seen psilocybin granted breakthrough therapy designation, which helped it fast-track into phase 2. That sets a strong precedent. I think we may see similar designations for compounds such as mescaline and others that are well understood by academia, and that have clear toxicity data in the existing literature.

More broadly, we’re seeing political and regulatory tailwinds. The new US Department of Health and Human Services Secretary Robert F. Kennedy, Jr, for example, has signaled support for moving psychedelic trials forward. So, especially for natural substances that are known, I think we’re looking at more of a superhighway—a more straightforward, faster route to pivotal trials. And if a company brings a well-designed phase 3 trial with strong safety and efficacy, that drug will get approved.

Pharmacy Times: What insights from Psychedelic Science do you think are most critical for pharmacists who are seeking to prepare for the integration of psychedelic therapies into certain aspects of clinical practice, such as palliative care?

Stanley: One of the biggest concerns raised, both at this year’s conference and in years past, is the shortage of trained therapists. Rick Doblin, the founder of MAPS, has spoken about this a lot. When these drugs get approved, we’re going to see high demand and not nearly enough qualified professionals to deliver the therapies safely.

The overall message is: We need to prepare the infrastructure—training, protocols, interdisciplinary collaboration—before the floodgates open.

Pharmacy Times: What role do you see pharmacists playing in the safe and effective delivery of psychedelic-assisted therapies once these products reach the market?

Stanley: Pharmacists will continue to play the critical role they’ve always had: Ensuring the correct formulation, dosage, labeling, and safety checks for drug interactions. While some psychedelic therapies require a multidisciplinary team, the pharmacist’s responsibility remains focused on the drug itself. They are essential in making sure patients receive these medicines safely and accurately, just as with any other regulated drug.