MDMA-Assisted Therapy Trial Participant Reacts to FDA’s Decision on Lykos’ NDA

Cristina Pearse

Credit: LinkedIn

Lykos Therapeutics’ announced Friday evening that the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for midomafetamine (MDMA) capsules for the treatment of post-traumatic stress disorder (PTSD).

This was upsetting news for many, including Cristina Pearse, founder of the Protea Foundation which advocates for innovative treatments to help treat survivors of sexual and domestic violence. Pearse participated in an MDMA-assisted therapy trial and experienced immense improvements in her PTSD symptoms.

In an interview with HCPLive, Pearse expressed disappointment in the FDA’s decision not to approve MDMA-assisted therapy, given her positive experience with this treatment.

HCPLive: What motivated you to participate in the MDMA-assisted therapy trial?

Pearse: What motivated me to participate in the trial was experiencing decades of a lack of success with other therapies to treat my PTSD. I did not realize that I had PTSD until my mid-40s, and I was absolutely confounded when I was prescribed the exact same medications as when I had been diagnosed previously with depression and anxiety.

I started to research other alternative therapies, emergent therapies and found this one. [I] had looked into ketamine as well but felt that this was a better one for me because of my circumstances, and so I then applied for the trial.

HCPLive: Did you have any specific concerns or reservations before enrolling in the trial?

Pearse: Naturally, [with] the uncertainty of taking what was considered a psychedelic drug. I'm MDMA naive, so I didn't know what to expect. I think, for me, I just really wanted the reassurance of exactly what I could expect or what I would anticipate from the experience. I wanted to be very clear about the risks. I wanted to understand the risk profile for the medication, especially for me being a sexual trauma survivor, wanting the reassurance that I would have agency throughout the treatment.

HCPLive: Could you describe the impact that MDMA-assisted therapy had on your PTSD symptoms, both immediately and over time?

Pearse: One of the reasons why I am such an advocate for this therapy is because of the profound positive changes in my own life. I have never experienced anything that unwound the traumas for me and shifted my perspective to the degree that I was actually able to address the actual trauma instead of just reacting and being more in a reactive state. It was a profound change for me to have the process of going through the MDMA and the therapy.

HCPLive: Were there any adverse events or challenges you encountered during the therapy sessions?

Pearse: As I understood from getting feedback from my therapists, I had very few side effects. Other people had more nausea; other people experienced other side effects. For me, I felt that, aside from the obvious things of having the increased heart rate… [I experienced] a sensation of warmth, maybe a little bit of jaw clenching.

Other than that, I well-tolerated the medication. I was very thankful for the lower dose in the initial experience, just to be able to understand how I would feel, and it gave me the confidence in the second and third experientials to tolerate it and anticipate its effects.

HCPLive: How did you feel about the FDA’s decision not to approve MDMA-assisted therapy, considering your personal experience?

Pearse: I am so disappointed because it's clear to me that this is something that can absolutely address complex trauma and trauma in general in a way that any existing medications can't touch. As a matter of fact, I feel like a lot of the SSRIs are actually dangerous. My experience was certainly that I became suicidal when I took an SSRI and other therapies actually brought me sort of closer to the edge, if you will.

I liked MDMA having the neurological repair that has to happen first before you can address trauma, the psychological and mental and cognitive aspects of it. To me, this was such a massive disappointment, because the amount of people that need this now who are in a life-and-death sort of equation, this is going to cost lives, and I think it is really important for us to keep in mind that this delay is denying people who are really grappling with suicidality. This is a really impactful delay.

HCPLive: Is there anything else you would like to highlight about this topic?

Pearse: In my own research, this MDMA therapy has been… well characterized. We understand what the clinical risks are. Again, it's just such a disappointment that this got mirrored down in the complexity of the therapy wrapper.

There are clearly bad actors at play in this, but I feel that they are having a really disproportionate impact on this decision, and so I just hope that we can get through the next steps in reassuring the clinical, medical, and research communities that this is, in fact, safe. It should at least be tested on [the] audience. But obviously, it's a major delay to have clinical trials reordered in this case, so I would just hope that we use our better heads to figure out a better path forward, other than demanding an entire clinical trial.