When will MDMA be FDA approved?

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Short answer:
  • Phase three of the therapeutic effects of MDMA is presently underway.
  • Clinical research has established MDMA's safety and effectiveness.
  • It has paved the way for MDMA's medical use for PTSD and an anticipated FDA approval in 2023.

In addition to the stimulant effects, the synthetic substance MDMA also produces hallucinogenic effects. MDMA's impact on the body is stimulating; time and perception get distorted, and sensory pleasure gets amplified.

Chemical structures of both MDMA enantiomers
Chemical structures of both MDMA enantiomers. , Public domain, via Wikimedia Commons

It's been called an entactogen, a medication that boosts introspection and compassion.

MDMA is proven to have medical applications. There are several ways it may assist patients with specific psychological issues.[1]

Patients who have been resistant to therapy for post-traumatic stress disorder respond better to MDMA assisted therapy[edit]

Hundreds of millions worldwide are affected by post-traumatic stress disorder (PTSD), a prevalent and devastating ailment with enormous social and economic repercussions.

PTSD has several causes, both environmental and biological, and is linked to a variety of co-occurring disorders that may negatively impact treatment success, such as :

  • Childhood trauma
  • Alcohol and substance use disorders,
  • Depression,
  • Suicidal ideation
  • Dissociation.[2]

The promising results of phase 2 trials led to the phase 3 trial of the drug[edit]

The drug 3,4-methylenedioxymethamphetamine (MDMA), a substituted amphetamine, causes serotonin to be released by binding to presynaptic serotonin transporters.

In animal models, MDMA helps eliminate fear memories, change how they get re-solidified (possibly through an oxytocin-dependent mechanism), and improve social behavior.

The results of a collated analysis of MDMA-assisted therapy for PTSD from multiple Phase 2 trials show that it is safe and works well.[3]

The compassionate usage of MDMA as a treatment for PTSD granted by the FDA[edit]

Compassionate use or Expanded access allows a patient with a severe or life-threatening illness or condition to obtain an experimental medical product (drug, biologic, or medical device) outside of clinical trials when no comparable or adequate alternative therapeutic choices are available.

The FDA has approved MDMA-assisted psychotherapy for PTSD for Expanded Access. It allows some patients access to MDMA-assisted therapy before it is fully approved. This is an essential step in the development of the treatment.

Ten treatment centers in the United States are ready to start giving the therapy. Phase 3 trials are underway, and full approval will likely come through by the end of 2023.[4]

The initial phase 3 results of MDMA are positive and in the queue for FDA approval[edit]

The data show that therapy works, even for people who are hard to help, like those with drug or alcohol use disorders.

MDMA has interesting applications as an empathogen. It makes the brain release oxytocin, which makes people feel open and trusting, which can be very helpful in a therapeutic setting.

In the initial phase 3, a randomized, double-blind, placebo-controlled study of MDMA-assisted therapy for treating PTSD, 90 people with severe PTSD, which is marked by memory loss, nightmares, and flashbacks related to a traumatic event in the past, took part.[5]

Second phase 3 trials of MDMA are currently under consideration, before the FDA approval comes through for PTSD[edit]

Researchers are currently looking for people to take part in a second phase 3 trial. If the results are the same, they think the FDA could approve MDMA-assisted therapy for PTSD by the end of 2023.[6]

A study was also just finished to see if MDMA-assisted therapy could help people with PTSD who haven't been helped by traditional treatments like SSRIs or therapy alone.

It seems to work just as well for people who are usually hard to treat. MDMA-assisted therapy is anticipated to be most effective treatment for this hard-to-reach group.[7]

Even though the early results are promising, the drug can't be considered a magic bullet for treating PTSD and other disorders. Instead, when combined with therapy, it becomes a powerful tool for treatment because it changes people's minds in ways that make them more open to the benefits of therapy.


  1. Gilman, Greg (2022-03-11). "Psychedelic Business Spotlight- March 11". Psychedelic Spotlight. Retrieved 2022-11-12.
  2. Mitchell, Jennifer M.; Bogenschutz, Michael; Lilienstein, Alia; Harrison, Charlotte; Kleiman, Sarah; Parker-Guilbert, Kelly; Ot’alora G., Marcela; Garas, Wael; Paleos, Casey; Gorman, Ingmar; Nicholas, Christopher (2021-06). "MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study". Nature Medicine. 27 (6): 1025–1033. doi:10.1038/s41591-021-01336-3. ISSN 1546-170X. PMC 8205851 Check |pmc= value (help). PMID 33972795 Check |pmid= value (help). Check date values in: |date= (help)
  3. Multidisciplinary Association for Psychedelic Studies (2022-01-27). "A Phase 2, Open Label Study of the Safety and Effectiveness of MDMA-assisted Therapy for Participants With Posttraumatic Stress Disorder". Cite journal requires |journal= (help)
  4. "FDA gives expanded access to MDMA as a treatment for PTSD". WUNC. 2022-05-12. Retrieved 2022-11-12.
  5. "First Phase 3 trial data for MDMA therapy sets path for approval". New Atlas. 2021-05-03. Retrieved 2022-11-12.
  6. "Expert: MDMA Is Very Likely to Be FDA-Approved for PTSD by the End of 2023". Pharmacy Times. Retrieved 2022-11-12.
  7. Staff, ScienceAlert (2022-03-22). "MDMA Shows Promising Results in Phase 3 Clinical Trial For PTSD Treatment". ScienceAlert. Retrieved 2022-11-12.