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FDA Advisory Committee Rejects MDMA-Assisted Therapy for PTSD: Awaiting FDA's Final Decision

The FDA is expected to decide by early August whether MDMA can be approved to treat Post Traumatic Stress Disorder (PTSD). Clinical trials have shown promising results, with participants describing the treatment as 'transformational'. However, concerns have emerged that threaten the drug's approval. The Institute for Clinical and Economic Review, a nonprofit that evaluates clinical trials, identified "substantial concerns about the validity of the results" of the MDMA trials. Additionally, a citizen petition to the FDA alleges possible misconduct and ethical violations. In response, the FDA held a public advisory committee meeting on June 4th to address these issues.

FDA Advisory Committee Review and Key Discussions

The FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) convened to review Lykos Therapeutics’ MDMA-assisted therapy for PTSD. The meeting featured presentations from the FDA and Lykos, public comments, and committee discussions.

Tiffany Farchione of the FDA highlighted the complexity and significance of the application, noting positive short-term study results, but raising concerns about unblinding, potential bias, and long-term study issues. She emphasized the need for a Risk Evaluation and Mitigation Strategy (REMS) due to safety concerns like cardiac risk and abuse potential.

Concerns About Psychotherapy and Misconduct Allegations

The committee discussed the role of psychotherapy in ensuring safety and efficacy, with Lykos stating that it contributes to use safety. Allegations of misconduct and study design flaws were also scrutinized. The panel debated the sufficiency of the available data, expressing concerns about patient impairment and the integrity of psychotherapy methods.

FDA staff and committee members also highlighted issues with the clinical research, citing a lack of evidence supporting the psychological approach used in the therapy sessions and potential bias from "functional unblinding." This occurs when participants and therapists can tell who received the experimental drug, potentially skewing the results. With psychedelic medicines, this aspect can be difficult to avoid.

Public Opinion and Committee Vote

Public comments included both support and criticism of MDMA-assisted therapy, with some highlighting the need for more rigorous oversight and better training for therapists. Ultimately, the committee voted 9-2 against MDMA therapy, citing insufficient data to demonstrate its effectiveness for PTSD treatment, and 10-1 that the available evidence doesn’t show that the drug’s benefits outweigh its risks.

Key Findings and Implications

Lykos emphasized the positive findings from two randomized controlled trials, noting that 67% of participants in the MDMA treatment arm no longer met the diagnostic criteria for PTSD after three sessions, compared to 32% in the placebo group. Despite this, the committee focused on shortcomings in the data, including concerns about the long-term durability of the treatment and the potential for abuse.

Issues with long-term follow-up data were also noted, including a 25% dropout rate and the use of illicit drugs by some participants. There were also allegations of unreported adverse events, including a case of inappropriate contact between therapists and a participant during a Phase 2 trial.


While the advisory recommendations and votes are not final, they may suggest the likely outcome of the FDA's decision on MDMA-assisted therapy ahead of the August 11th deadline. This outcome represents a significant setback for the potential approval and use of MDMA-assisted therapy in mental health care. Currently, there are only two FDA-approved treatments for PTSD (sertraline and paroxetine), and the approval of MDMA would signify the first new option in decades, marking a significant milestone and offering renewed hope for PTSD patients.

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