FDA Advisory Committee to Meet Soon to Discuss MDMA-Assisted PTSD Treatment

The FDA’s Psychopharmacologic Drugs Advisory Committee will meet June 4 to review a new drug application (NDA) from Lykos Therapeutics for midomafetamine (MDMA)-assisted therapy to treat post-traumatic stress disorder (PTSD) .¹

FDA advisory committee to meet soon to discuss MDMA-assisted therapy for PTSD / Tada Images – stock.adobe.com

FDA Advisory Committee to Meet Soon to Discuss MDMA-Assisted PTSD Treatment

What is the problem?

The committee meeting will be the first to examine psychedelic-assisted therapy in the United States, as well as the first in 25 years to examine a potential new treatment for PTSD.

Lykos’ NDA was accepted for priority review by the FDA on February 9, 2024. It was assigned a Prescription Drug User Fee Act (PDUFA) date of August 11, 2024.
If approved by the FDA, it would be the first MDMA-assisted therapy and the first psychedelic-assisted therapy in the country.
MDMA (3,4-methylenedioxy-methamphetamine), more commonly known as ecstasy, is an entactogen, a type of psychoactive compound characterized by its ability to increase self-awareness. It is classified by the Drug Enforcement Agency as a Schedule I drug of the Controlled Substances Act.

READ MORE: Psychedelic Pharmacy: A Paradigm Shift in Mental Health Treatment

Why is this important

Since the Controlled Substances Act was passed in 1970 and federal drug schedules were established, most psychedelic substances have been placed on Schedule I and considered to have no medical benefit. Not only would the approval of MDMA represent a historic shift in psychedelic medicine, it could also “open the door to a potentially powerful new path to recovery” for PTSD patients, according to Bessel van der Kolk, MD.²

PTSD, which develops after exposure to a potentially traumatic event, affected 3.6% of adults in the United States last year. The disease has a lifetime prevalence of 6.8%.³
Patients with PTSD may experience persistent, frightening thoughts and memories, problems sleeping, feel detached or numb, or be easily startled. Severe forms can impair the ability to function at work, at home and socially.³
Research has shown that more than 30% of general population PTSD patients are resistant to treatment, highlighting the critical need for new forms of therapy.⁴

Expert commentary

“This will be the first MDMA-assisted therapy and psychedelic-assisted therapy to be reviewed by the Psychopharmacologic Drugs Advisory Committee, a milestone in the field of psychedelic medicine, the result of decades of clinical research and advocacy.” , Amy Emerson, CEO of Lykos Therapeutics, said in a statement.¹ “We look forward to the opportunity to discuss the full body of data on investigational MDMA and how, if approved, it can be used as a prescription treatment in combination with psychological intervention in adults suffering PTSD.”
“MDMA is an experiential therapy and therefore requires an appropriate package and framework to truly guide change and recovery,” Jennifer Mitchell, PhD, said in a statement.² “Although many forms of therapy for PTSD involve recalling past trauma, MDMA’s unique ability to elicit compassion and understanding while alleviating fear is likely what allows it to be so effective. “
“Thirty-eight years ago, one of my primary motivations for founding MAPS was to chart a path for psychedelic-assisted therapies to become FDA-approved treatments,” Rick Doblin, founder and president of the Multidisciplinary Association for Psychedelic Studies (MAPS), said in a statement.⁵ “We hope that the FDA’s potential approval of MDMA-assisted therapy for PTSD is only the first of many psychedelic-assisted therapies that are becoming available by prescription.”

In-depth information

The FDA’s acceptance of Lykos’ NDA was based on data from 2 phase 3 clinical trials: MAPP1 (NCT03537014) and MAPP2 (NCT04077437).

Randomized, double-blind, placebo-controlled trials evaluated the effectiveness and safety of MDMA used in combination with psychological intervention compared to placebo in patients diagnosed with severe or moderate-to-severe PTSD.
MAPP1 included 90 participants randomly assigned to receive manual therapy with MDMA or placebo, combined with 3 sessions of preparative therapy and 9 sessions of integrative therapy. The study found that MDMA induced significant and robust attenuation of PTSD symptoms.⁶
MAPP2 included 104 participants who were randomly assigned to MDMA-assisted treatment or placebo with treatment. The study found that average changes in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score were -23.7 for MDMA, compared to -14.8 for placebo.⁷

FDA Advisory Committee to Meet Soon to Discuss MDMA-Assisted PTSD Treatment

What is the problem?

Why is this important

Expert commentary

In-depth information

Further reading

Reference

3. Post-traumatic stress disorder (PTSD). Report. National Institute of Mental Health. Accessed May 7, 2024. https://www.nimh.nih.gov/health/statistics/post-traumatic-stress-disorder-ptsd

5. MAPS congratulates Lykos Therapeutics on the acceptance of the New Drug Application for the treatment of MDMA-assisted PTSD. Press release. PLANS. February 9, 2024. Accessed February 12, 2024. https://maps.org/2024/02/09/maps-congratulates-lykos-on-acceptance-of-new-drug-application/

6. Mitchell, J.M., Bogenschutz, M., Lilienstein, A. et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med 27, 1025-1033 (2021). https://doi.org/10.1038/s41591-021-01336-3

7. 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 29, 2473-2480 (2023). https://doi.org/10.1038/s41591-023-02565-4