Yesterday evening, Lykos Therapeutics announced that the US Food and Drug Administration (FDA) has issued a negative opinion on its new drug application for the treatment of PTSD. The FDA has requested additional Phase 3 studies to further evaluate the safety and efficacy of the intervention.

 

This decision follows the June meeting of the FDA Psychopharmacologic Drugs Advisory Committee, which made a non-binding recommendation against approving MDMA-assisted therapy, citing concerns about the design of some studies among other issues.

 

PAREA regrets this negative decision by the FDA. The Lykos clinical trials had marked a turning point for a field that had seen stagnation in innovation for decades.

 

A Phase 3 study by Lykos, published in Nature Medicine in 2023, revealed that two-thirds of participants in the treatment group no longer qualified for a PTSD diagnosis, with results sustained for over six months. The study demonstrated that MDMA-enhanced therapy is nearly twice as effective as therapy without the drug. This finding was recognized as one of Science magazine’s ten breakthroughs of 2021, alongside advances in Covid-19 and nuclear fusion.

 

People living with PTSD and other mental health conditions, as well as their families, had high hopes and expectations for the introduction of this new treatment option. Although this decision pertains to the US and there is no current market application for this treatment in Europe, we are concerned that the regulatory expectations could set a precedent that might slow down progress in mental health innovation worldwide.

 

The unmet needs of the PTSD patient population are profound: PTSD affects approximately 13 million Americans each year and 8 million in Europe. There has been no new PTSD drug approved for more than two decades, making MDMA-assisted therapy the best hope for people who are currently struggling and not being helped by existing treatments.

 

To illustrate the real-life impact of this therapy, you can watch a testimonial from a patient at a PAREA event who benefited from MDMA-assisted therapy for Alcohol Use Disorder related to PTSD.

 

In a July statement, scientists and clinicians with expertise in drug-assisted psychotherapy argued that the concerns about study design aren’t significant enough to “call the main clinical trial findings into question,” noting that “serious adverse events are rare,” and that “MDMA is now approvable for use with therapy in the treatment of PTSD.”

 

To address the key concerns raised by the FDA and its advisory committee, PAREA, in collaboration with Drug Science and Mind Medicine Australia, has recently published an extensive position statement. This document addresses issues such as regulating a treatment that combines MDMA and psychotherapy, blinding and expectation, misuse risks of MDMA, training of therapists, risks of therapist misconduct and boundary violations, uncertain long-term benefits, and the negative benefit-risk ratio.

 

MDMA-assisted therapy represents an entirely new model of care. Over 12 weeks, this approach combines outpatient psychotherapy with three, day-long, MDMA-assisted sessions. This approach moves away from a purely biologically deterministic model that views mental health challenges as unbalanced brain chemistry requiring daily medication. Instead, it is grounded in a relationship-centred approach that views mental health through a biopsychosocial lens. Unfortunately, the FDA and its advisory committee are not accustomed to including psychotherapy as a variable in assessing the effectiveness and risks of a medicine.

 

PAREA remains committed to a holistic approach to mental health care, where innovative psychedelic treatments are integrated with psychological support and eventually incorporated into community-based health and social care services. The broader psychosocial context is crucial for understanding and alleviating mental health issues.

 

Despite this setback, PAREA remains encouraged by the ongoing investment in research and development of new psychedelic treatments, with 29 clinical trials currently underway in the EU alone. We reiterate our call for continued EU and EU member states funded research in this area and advocate for the establishment of a European Hub for Mental Health R&D.