Drug Science and UCL to tackle FDA concerns on therapy component of MDMA treatment

After 30 years of research and eight clinical trials by the Multidisciplinary Association for Psychedelic Studies (MAPS [now Lykos Therapeutics]), MDMA therapy for PTSD was granted Breakthrough Therapy Status due to positive results.

However, in June, the FDA rejected the treatment, citing concerns about blinding, potential misuse, risk of unethical conduct, long-term benefits, training challenges, and an unfavourable benefit-risk ratio. Another major issue is the regulation of combination therapy, as the FDA does not have jurisdiction over psychotherapy, making regulation a considerable challenge.

Experts argue that this therapy component is essential for the long-term success of MDMA-assisted psychotherapy.

In a recent position statement published by Drug Science, a UK non-profit advocating for evidence-based drug policy, Mind Medicine Australia, a psychedelic therapy organisation, and PAREA, a European advocacy group, the organisations highlight that: “The Lykos submission is the first instance where a combination of drug plus psychotherapy has been submitted to the FDA for regulatory approval…

“This scenario creates uncertainty for regulators as they have no direct precedent and lack the authority to adjudicate on the psychotherapy component.”

Similarly, Drug Science emphasises that the interaction between MDMA treatment and its therapeutic component is poorly understood.

They suggest that a “refined understanding of this interaction may require a shift away from the traditional methods of evaluation typically used in neuroscience and psychopharmacology.”

To address these concerns over MDMA’s therapy component, Drug Science’s new collaboration with UCL aims to explore different therapeutic modalities to assess their compatibility with MDMA and to identify the key features of the psychotherapeutic model that are crucial to its effectiveness.

Professor David Nutt, Founder of Drug Science, commented in a press statement: “MDMA-assisted therapy has shown great promise, but the recent decision by the FDA highlights the necessity for further research.

“Our collaboration with UCL aims to address the specific concerns raised, particularly around the regulation of combination therapy and therapist training.

“This partnership is crucial for developing a more refined and evidence-based understanding of MDMA’s therapeutic potential.”

Drug Science and UCL say they will be taking a bold and alternative approach to understanding how MDMA works.

In the press statement, Prof Sunjeev Kamboj, Professor of Translational Clinical Psychology at UCL stated: “Modern neuroscience and pharmacological experiments have been pivotal in driving our understanding of MDMA and psychedelics. But we’re now at an impasse in understanding of how these drugs work at a high level.

“This is why we are taking an unusual, more qualitative approach to tackling this issue by testing the effects of MDMA in psychotherapists who have a strong foundation in theories of psychopathology.

“We think this will be a critical step in advancing our understanding of the psychological, rather than neurobiological, mechanisms of action of MDMA”.

The collaboration aims to produce a set of practical understandings that can be directly implemented in a standardised way to help advance the treatment’s safety and efficacy. Recruitment for study participants will begin in 2025.