Reagan Udall Foundation for FDA Facilitates Discussion on Urgent Needs in PTSD Therapy

Reagan Udall Foundation for the US Food and Drug Administration (FDA), a non-profit organization created by Congress, hosted the hybrid public meeting “Advancing Treatments for Post-Traumatic Stress Disorder” on September 6, 2024.

Individuals with post-traumatic stress disorder (PTSD), experts, and federal partners convened to voice their thoughts on the unmet need in the PTSD space and how we should proceed in advancing PTSD treatments.

Bernard A. Fischer, MD, a psychiatrist and the Deputy Director of the Division of Psychiatry in the Office of New Drugs in the FDA, presented the opening remarks with his presentation, starting with how PTSD was not recognized as a mental health disorder until the 1980s.

Until then, PTSD was brushed off as simply “nostalgia” or “soldier’s heart” or “shellshock.” Even though PTSD was not recognized as a mental disorder into the ‘80s, PTSD symptoms were depicted in Greek tragedies and Shakespeare, with symptoms of isolation, decreased libido, physical symptoms, insomnia, startle response, depressed mood, and nightmares.

Many people experience PTSD. In any given year, 4% of men and 10% of women in the US battle this psychiatric condition. Although psychotherapies are effective at reducing the perceived threat, it is not only time-consuming but difficult for patients to talk about their trauma. The approved PTSD treatments—sertaline and paroxetine—only have symptomatic relief and does not work for everyone.

Fischer said the FDA recognizes the unmet need for safe and effective PTSD treatments. On behalf of the FDA, he advised clinical trials to have a representative sample, informed by knowledge of the brain/body, and informed by studies of resilience or by people who do not get PTSD.

Federal partners shared many PTSD resources, including SAMHSA, a crisis lifeline, mental health block plans and grants, and programs to fight PTSD in children. Moreover, speaker Miriam J. Smyth, PhD, the acting director of the Clinical Science Research & Development Service explained how many clinical trials are evaluating treatment options for PTSD.

Psychopharmacology trials began in 2017 and currently have 14 active trials with the first one ending later this year. The military veteran program has a large study with 1 million and 43 thousand veterans assessing how genes, lifestyle, military experiences, and exposures affect a veteran’s well-being. Smyth ended by mentioning trials on psychedelic-assisted therapy—particularly, Lykos Therapeutics’ MDMA-assisted therapy trials. More participants will likely be recruited for a new MDMA trial in the fall.

The stakeholder comment segment of the meeting allowed people with PTSD and experts to talk about the current PTSD treatment landscape and how trauma impacts lives. Repeatedly, people brought up the FDA’s decision on MDMA-assisted therapy for PTSD.

Robert M. Grant, MD, MPH, professor of Medicine at the University of California-San Francesco, began his public comment with, “I am a friend of the FDA.”

Before he had trained in MDMA psychotherapy, he was on the FDA advisory committee. Although he had previously sat on the committee, he believes this current committee failed its recent review of MDMA.

“The FDA failed to provide consistent guidance to the industry, failed to stand by guidance they had previously given, and failed to provide essential context for their external advisors,” Grant said.

Despite the FDA issuing a complete response letter for MDMA-assisted therapy, Leith J. States, MD, MPH, MBA, FACPM, the assistant secretary for Health at the US Department of Health and Human Services (HHS), believes advancing PTSD treatments “…doesn’t happen in a vacuum.”

“There’s a lot of nasty stuff in there, but at the end of the day, we’re moving forward, and although we may want to see different speeds happen… it’s been really encouraging to see and work alongside a lot from the faces I see in this room,” States said. “The actual Holy Grail here for me is restoration, which I think is in reach with appropriate leveraging of what’s on the horizon.”

Before MDMA-assisted therapy, Mary Armstrong faced generational trauma and traumatic experiences throughout her childhood. By 21 years old, she was considered morbidly obese and went into surgery.

It was after the operation she started facing suicidal ideation. She tried all the drugs and treatments she could but had no luck—until MDMA-assisted therapy. The treatment allowed her to hold her memories and reframe a lifetime of trauma.

“Maybe there were flaws in that study, but I didn’t have time to find out. I had no time left. I was going to end up at the bottom of a bay if I didn’t make a decision to do something wild and crazy that I’ve only done in a clinical setting,” Armstrong said. “This can make all of the difference in whether someone lives or does not.”