Crisis Point: Psychiatry at a Crossroad Following FDA Decision on MDMA-Assisted Therapy

This is Crisis Point.

Our mini-docuseries has returned, taking a comprehensive look at public health crises affecting the United States today, with global implications tomorrow. If the crisis point is the moment where a crisis will worsen or begin to get better, the question remains: where are we now?

This episode captures reactions following the US Food and Drug Administration’s (FDA) decision on MDMA-assisted therapy for PTSD.

What could have been a monumental moment in medicine left many people disappointed, as the FDA decided to issue a Complete Response Letter (CRL) for midomafetamine (MDMA) capsules to treat post-traumatic stress disorder (PTSD).

Lykos Therapeutics announced the FDA’s decision on Friday, August 9, 2024. Despite the extensive positive evidence Lykos Therapeutics gathered on MDMA-assisted therapy for PTSD, the decision did not look as promising after FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) cited concerns about safety, cardiovascular risks, and issues related to functional unblinding in trial settings at their meeting on June 4, 2024.

Not only is there an unmet need for PTSD treatment, as expressed by many experts, but conducting another phase 3 trial will be both expensive and time-consuming. A former investigator of the MAPs-sponsored trial was surprised the CRL required Lykos Therapeutics to conduct another phase 3 trial since the pivotal data was well-supported.

We spoke to PTSD experts and a participant in Lykos’ trials, and all 3 voiced concerns of this decision:

• Casey A. Paleos, MD, adult psychiatrist in a New York-based private practice and the Chief Medical Officer of InnerMost PBC. Principal investigator for the MAPS-sponsored MDMA-Assisted Therapy for PTSD Phase 3 Clinical Trials (2018-2023)
• Jerrold Rosenbaum, MD, director of the Center for the Neuroscience of Psychedelics at Massachusetts General Hospital and psychiatry professor at Harvard Medical School
• Cristina Pearse, founder of the Protea Foundation and participant in the MDMA trial

Although MDMA-assisted therapy will not be approved any time soon, experts remain hopeful this treatment option will be available later down the road.

“It’s a question of when and not if,” Paleos told HCPLive.

References

^{Derman, C. FDA Rejects Application for MDMA-Assisted Therapy in PTSD, Calls for Additional Trial. HCPLive. August 9, 2024. https://www.hcplive.com/view/fda-rejects-application-for-mdma-assisted-therapy-in-ptsd-calls-for-additional-trial. Accessed August 15, 2024.}