Awaiting FDA Decision on MDMA-Assisted Therapy, with Bessel van der Kolk, MD

The anticipated US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) meeting on Tuesday, June 4, will set the stage for the FDA’s eventual decision on Lykos Therapeutics’ New Drug Application (NDA) for midomafetamine (MDMA)-assisted therapy for the treatment of patients with PTSD.

The third-party committee’s votes for or against the clinical benefit of MDMA-assisted therapy—based on the company’s pivotal phase 3 data from the MAPP1 and MAPP2 clinical trials—as well as the FDA’s risk and evaluation mitigation strategy (REMS) for management of the procedure will likely influence the agency’s decision whether or not to approve the NDA later this summer.

With a new era of psychedelic therapy for psychiatric disease in reach, experts are giving their perspective on the best ways to effectively, safely and ethically administer potent, unique drugs like MDMA.

In the final segment of an interview with HCPLive, Bessel van der Kolk, MD, co-founder and chair of the Trauma Research Foundation, discussed the prospective rollout of MDMA-assisted therapy to patients with PTSD following an FDA decision. To van der Kolk, a prolific researcher and author in the field of clinical trauma care, there are 3 primary concerns.

The first is what he called the “non-scientific approach” to confining the treatment’s indication only to patients who meet DSM criteria for PTSD.

“What our study clearly shows is that MDMA does not affect ‘PTSD’,” van der Kolk said. “In fact, whoever created us did not create us having PTSD. PTSD is a function of a committee that put certain symptoms together.”

Next, van der Kolk said it may be logistically unrealistic and costly to replicate the MAPP trial design, wherein 2 therapists monitored the patient at a time during the lengthy in-person, self-administered dose sessions. That said, he called it “terribly important” to ensure a patient is adequately monitored and provided care outside of the coinciding psychotherapy session.

With that thought, van der Kolk said his final concern is whether his colleagues are knowledgeable enough on the psychoactive effects of MDMA; he believes it would be appropriate and beneficial for patients to be treated by psychiatrists who have experienced the effects of the drug as well—though of course, this is not a requirement the FDA could warrant.

“On MDMA, your trauma does come back, and all kinds of stuff that you may have forgotten tends to come up,” van der Kolk said. “So they tend to be quite harrowing experiences. And having somebody be with you—who really knows you well, who you can trust—is terribly important.”

While these points and more will likely be thoroughly reviewed by experts in the advisory committee meeting Tuesday, van der Kolk’s strongest sentiment remains his endorsement of the clinical trial data as validity of MDMA-assisted therapy’s benefit for patients with PTSD.

“I’ve done this work now for 50 years,” he said. “I have devoted my career to exploring treatments and found many things that work. But I must say that this is the most revolutionary thing that I've seen happen in psychiatry in the 50 years that I've been part of it.”