Interpreting Trial Data for MDMA-Assisted Therapy, with Gus Alva, MD

EP: 1.Current Options and Unmet Need in PTSD, with Gus Alva, MD

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EP: 2.Interpreting Trial Data for MDMA-Assisted Therapy, with Gus Alva, MD

EP: 3.Addressing Stigma Surrounding MDMA and Psychedelic Therapies, with Gus Alva, MD

EP: 4.Future Research Priorities for MDMA-Assisted Therapy in PTSD, with Gus Alva, MD

EP: 5.Prospect of Psychedelic Therapies in Psychiatry, with Gus Alva, MD

As August 11, 2024 approaches, the psychiatric community, and public health as a whole, wait with anticipation surrounding the US Food and Drug Administration’s decision on 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy in the management of posttraumatic stress disorder (PTSD).

A subject mired in controversy as a result of decades-old stigma, MDMA-assisted therapy has, with extensive research efforts and clinical trial data, proven its potential. Beyond MDMA-assisted therapies, clinical programs and trials for other psychedelic agents, including psilocybin, ketamine, and other compounds, have furthered discussions around the roles of these therapeutic options in psychiatric care.

Backed by positive data from the phase 3, randomized, double-blind, placebo-controlled MAPP1 and MAPP2 trials, the application for MDMA-assisted therapy PTSD seemed poise to usher in a new era in management.

However, the road to a potential approval has seemingly turned into an even greater uphill battle in the wake of an FDA Psychopharmacologic Advisory Committee on June 4, 2024, which saw the committee vote 2-9 against supporting the effectiveness of MDMA in the treatment of adult patients with PTSD followed by a subsequent 1 to 10 vote against the notion that the benefits of MDMA in combination with the FDA’s proposed risk evaluation and mitigation strategy (REMS) outweigh its risks for the treatment of patients with PTSD.

Despite this, leading researchers, psychiatrists, as well as patients and advocacy organizations, have vocalized their concerns surrounding the unmet need in PTSD management and the need to research further the use of psychedelic therapies for use in psychiatric conditions.

In this 5-part video series, we spotlight the perspective of leading subject matter expert Gus Alva, MD, a psychiatrist and medical director of ATP Clinical Research, on the subject, with segments dedicated to:

1. Current Options and Unmet Needs in PTSD
2. Interpreting Trial Data for MDMA-Assisted Therapy
3. Addressing Stigma Surrounding MDMA and Psychedelic Therapies
4. Prospect of Psychedelic Therapies
5. Future Research Priorities for MDMA-Assisted Therapy

In this segment, Alva examines the growing body of evidence supporting the efficacy of MDMA-assisted psychotherapy in the treatment of PTSD. Despite some criticism regarding study design issues, the data consistently demonstrate that MDMA significantly enhances the therapeutic process. The discussion addresses common concerns, including the potential for abuse and misuse of MDMA, often highlighted by its association with recreational use at events like raves. However, Alva emphasizes the critical differences between controlled clinical use and recreational abuse. In a therapeutic setting, MDMA is administered in a controlled environment, with precise dosing and constant supervision by 2 therapists, ensuring patient safety and maximizing therapeutic benefit. The segment also touches on the FDA's cautious approach to this novel treatment modality, noting that while some skepticism remains, the established efficacy of MDMA-assisted psychotherapy is promising.

Relevant disclosures for Alva include Teva Pharmaceuticals, Otsuka America Pharmaceuticals, AbbVie Inc., Axsome Therapeutics, Janssen Pharmaceuticals, and more.

References:

1. Mitchell JM, Ot'alora G M, van der Kolk B, et al. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med. 2023;29(10):2473-2480. doi:10.1038/s41591-023-02565-4
2. Kunzmann K. FDA Psychopharmacologic Advisory Committee votes against supporting effectiveness of MDMA FOR PTSD. HCP Live. June 4, 2024. Accessed July 26, 2024. https://www.hcplive.com/view/live-updates-fda-psychopharmacologic-advisory-committee-meeting-mdma-ptsd.
3. Campbell P. First Study of Psilocybin in PTSD shows promise, safety of treatment approach. HCP Live. May 9, 2024. Accessed July 26, 2024. https://www.hcplive.com/view/first-study-of-psilocybin-in-ptsd-shows-promise-safety-of-treatment-approach.