Key TakeawaysThe FDA declined to approve MDMA as a treatment for PTSD, requesting further clinical trials to address safety concerns and data integrity.Despite promising results from previous studies, the FDA’s advisory panel cited issues with trial design and misconduct.Advocates of MDMA-assisted therapy say the FDA’s decision was disappointing for people with PTSD, who have limited treatment options.

Key Takeaways

The FDA declined to approve MDMA as a treatment for PTSD, requesting further clinical trials to address safety concerns and data integrity.Despite promising results from previous studies, the FDA’s advisory panel cited issues with trial design and misconduct.Advocates of MDMA-assisted therapy say the FDA’s decision was disappointing for people with PTSD, who have limited treatment options.

The effort to get federal approval for psychedelics to be used in health care hit a roadblock when the Food and Drug Administration (FDA) declined to approve MDMA as a treatment forpost-traumatic stress disorder (PTSD)last week.

The FDA’s decision comes two months after an advisory panelvoted overwhelmingly against approving the use of MDMA-assisted therapy. Two phase 3 clinical trials provided compelling evidence that treatment was effective at resolving PTSD symptoms for many participants. However, the panelists voiced concerns about patient safety and data integrity.

The drug sponsor, Lykos Therapeutics, said the FDA denied its application based on the data submitted and asked the company to conduct another phase 3 trial to study the safety and efficacy of MDMA. The company said it would ask the FDA to reconsider that decision.

“Our heart breaks for the millions of military veterans, first responders, victims of sexual and domestic abuse, and countless others suffering from PTSD who may now face more years without access to new treatment options. We intend to work tirelessly and use all available regulatory pathways to find a reasonable and expeditious path forward for patients who deserve access to midomafetamine-assisted therapy for PTSD,” Emerson added.

The decision is a setback for some psychedelics researchers and advocates for people with PTSD, including veterans groups. Though there are several psychotherapies and pharmacologic treatments for the disorder, as many as half of people with PTSD don’t respond to any of the approved options.No new PTSD treatment has been approved in nearly 25 years.

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The Rocky Road to an FDA Decision

For decades, the pharmaceutical industry and psychedelics researchers have been interested in how mind-altering psychedelics could be used to support mental health care. After researchers started testing MDMA in humans, they found promising results. In the last few months, however, regulators have raised concerns about instances of misconduct and shoddy data collection.

In 2017, Lykos met with the FDA for recommendations on designing a clinical trial for MDMA-assisted therapy that could provide data strong enough for approval. That same year, the FDA designated MDMA as a “breakthrough therapy” and signed off on Lykos’ study design.

In two randomized control clinical trials, participants had three treatment sessions, spaced at least weeks apart. In each session, participants received two doses of MDMA and at least eight hours of therapy from two healthcare providers, at least one of whom had to be licensed.

Those trials found that 67% and 71% of people who received MDMA-assisted therapy no longer met the criteria for PTSD, compared to 32% and 48% of people in the placebo group, respectively.

Despite those favorable results, the Institute for Clinical and Economic Reviewpublished a reporttwo weeks before the FDA advisory panel meeting, citing concerns about the validity of the data presented in the clinical trial and potential safety issues for patients receiving the therapy.

The FDA advisory panel voted 9-2 against recommending the approval of the therapy. A major concern was the difficulty in ensuring that both participants and therapists remained unaware of whether someone took MDMA or a placebo, which could introduce bias into the study.

Some panelists also raised concerns that up to 40% of participants had tried MDMA before enrolling, so they likely had a familiarity and comfort with the drug that the general population may lack.

Lykos said the FDA was aware of the participants’ backgrounds before the trial started and never raised a red flag. The company also said the advisory panel included too few experts on psychedelics-assisted therapy and that the conversation “at times veered beyond the scientific content in the briefing documents.”

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Misconduct During the Trials

Lykos said the research in those papers was from early phase studies and was not used in the application to the FDA and that the oversight could have been addressed in a correction.

Acitizens’ petitionto the FDA advisory panel from participants in the MAPS trial said that investigators were sometimes discouraged from reporting suicide attempts and ideation. The FDA advisors raised concerns that the dataset may not reflect the true outcomes of trial participants.

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A Setback in the Decades-Long Effort to Bring Psychedelics to Market

MDMA is a synthetic compound that works as a stimulant and hallucinogen. But it can also work as an “empathogen,” a drug that can increase feelings of trust, empathy, and connectedness to others. In the 1960s, psychiatrists in the U.S. began to study how the drug can improve therapy outcomes.

In 1985, the Drug Enforcement Agency classified MDMA as a Schedule I drug, making its use illegal.Since then, psychedelics researchers have sought to legalize the medical use of MDMA for PTSD and other mental health conditions.

Proponents of psychedelic-assisted therapy argue it’s a promising treatment for a population that desperately needs new options, including many combat veterans who say MDMA has allowed them to overcome debilitating PTSD symptoms for the first time.

Ahead of the FDA’s decision, 61 bipartisan members of the House of Representativessent a letterto President Biden, and 19 senators wrote to the FDA Commissioner Robert Califf, emphasizing high suicide rates and other consequences of untreated PTSD for U.S. veterans.

Veterans advocacy organizations like Veterans Exploring Treatment Solutions (VETS) and the Heroic Hearts Project provide resources for veterans living with PTSD to get access to psychedelic-assisted therapy in other countries where the treatment is legal or unregulated.

“The potential of MDMA-assisted therapy to help veterans heal from post-traumatic stress disorder (PTSD) remains paramount. We will not allow bureaucratic processes to deter us from advocating for approval of this transformative treatment,” a VETS statement said.

A statement from the Heroic Hearts Project said, “We will continue to push for progress, collaborate with stakeholders, and fight persistently until MDMA-AT is available to every Veteran who desperately needs and deserves it.”

Psychedelics researchers say that MDMA may benefit several mental health conditions. According toClinicalTrials.gov, more than 30 MDMA studies are now underway.More than half of those studies are investigating MDMA treatment for PTSD, while others focus on the drug’s effects for conditions such as liver impairment, eating disorders, social anxiety, and obsessive-compulsive disorder.

The psychedelics research movement extends beyond MDMA. Two companies are conducting phase 3 trials to test psilocybin in people with treatment-resistant depression.

“Lykos and MAPS were first-movers. They were an organization, then a company, that were moving first through this door. It’s disappointing, but understandable, that the FDA wants to set a very, very strong standard for psychedelic therapies,” saidIngmar Gorman, PhD, chief executive officer and co-founder at Fluence, a psychedelic education company for mental health providers.

“There is a wave of other companies that will follow in Lykos’ footsteps,” Gorman said.

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What This Means For YouMDMA remains a Schedule 1 substance, meaning federal regulators have not approved any medical use for it. While MDMA-assisted therapy shows potential for treating PTSD, it may not be available in the U.S. for several more years until Lykos or another company can provide robust enough data for the FDA.

What This Means For You

MDMA remains a Schedule 1 substance, meaning federal regulators have not approved any medical use for it. While MDMA-assisted therapy shows potential for treating PTSD, it may not be available in the U.S. for several more years until Lykos or another company can provide robust enough data for the FDA.

6 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Brady F, Warnock-Parkes E, Barker C, et al.Early in-session predictors of response to trauma-focused cognitive therapy for posttraumatic stress disorder.Behav Res Ther.2015;75:40-47. doi:10.1016/j.brat.2015.10.001Mitchell JM, Bogenschutz M, Lilienstein A, et al.MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.Nat Med. 2021:27;1025–1033. doi:10.1038/s41591-021-01336-3Mitchell JM, Ot’alora GM, 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;2473–2480. doi:10.1038/s41591-023-02565-4Food and Drug Administration Center for Drug Evaluation and Research.Final summary minutes of the Psychopharmacologic Drugs Advisory Committee meeting, June 4, 2024.CBC.Drug policy group condemns psychedelic research association for response to B.C. sex assault claims.Passie T, Benzenhöfer U.The history of MDMA as an underground drug in the United States, 1960-1979.J Psychoactive Drugs. 2016;48(2):67-75. doi:10.1080/02791072.2015.1128580

6 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Brady F, Warnock-Parkes E, Barker C, et al.Early in-session predictors of response to trauma-focused cognitive therapy for posttraumatic stress disorder.Behav Res Ther.2015;75:40-47. doi:10.1016/j.brat.2015.10.001Mitchell JM, Bogenschutz M, Lilienstein A, et al.MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.Nat Med. 2021:27;1025–1033. doi:10.1038/s41591-021-01336-3Mitchell JM, Ot’alora GM, 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;2473–2480. doi:10.1038/s41591-023-02565-4Food and Drug Administration Center for Drug Evaluation and Research.Final summary minutes of the Psychopharmacologic Drugs Advisory Committee meeting, June 4, 2024.CBC.Drug policy group condemns psychedelic research association for response to B.C. sex assault claims.Passie T, Benzenhöfer U.The history of MDMA as an underground drug in the United States, 1960-1979.J Psychoactive Drugs. 2016;48(2):67-75. doi:10.1080/02791072.2015.1128580

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Brady F, Warnock-Parkes E, Barker C, et al.Early in-session predictors of response to trauma-focused cognitive therapy for posttraumatic stress disorder.Behav Res Ther.2015;75:40-47. doi:10.1016/j.brat.2015.10.001Mitchell JM, Bogenschutz M, Lilienstein A, et al.MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.Nat Med. 2021:27;1025–1033. doi:10.1038/s41591-021-01336-3Mitchell JM, Ot’alora GM, 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;2473–2480. doi:10.1038/s41591-023-02565-4Food and Drug Administration Center for Drug Evaluation and Research.Final summary minutes of the Psychopharmacologic Drugs Advisory Committee meeting, June 4, 2024.CBC.Drug policy group condemns psychedelic research association for response to B.C. sex assault claims.Passie T, Benzenhöfer U.The history of MDMA as an underground drug in the United States, 1960-1979.J Psychoactive Drugs. 2016;48(2):67-75. doi:10.1080/02791072.2015.1128580

Brady F, Warnock-Parkes E, Barker C, et al.Early in-session predictors of response to trauma-focused cognitive therapy for posttraumatic stress disorder.Behav Res Ther.2015;75:40-47. doi:10.1016/j.brat.2015.10.001

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

Mitchell JM, Ot’alora GM, 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;2473–2480. doi:10.1038/s41591-023-02565-4

Food and Drug Administration Center for Drug Evaluation and Research.Final summary minutes of the Psychopharmacologic Drugs Advisory Committee meeting, June 4, 2024.

CBC.Drug policy group condemns psychedelic research association for response to B.C. sex assault claims.

Passie T, Benzenhöfer U.The history of MDMA as an underground drug in the United States, 1960-1979.J Psychoactive Drugs. 2016;48(2):67-75. doi:10.1080/02791072.2015.1128580

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