The FDA’s recent decision to reject MDMA-assisted therapy for market approval is undoubtedly disappointing, but not entirely surprising. This therapy, disruptive in both regulatory and clinical delivery perspectives, faced a rigorous review process, serving as a reality check for the challenges involved in approving groundbreaking drugs. Yet, this moment represents a crucial opportunity for the sector, one that will ultimately enhance research practices and advance scientific understanding.

Despite the widely recognised need for PTSD treatments and inspiring patient stories supporting MDMA-assisted therapy, an overwhelming majority of the FDA’s Advisory Committee found the efficacy data unsatisfactory and concluded that the benefits didn't outweigh the risks due to methodological and misconduct issues. Although the panel's rejection doesn't guarantee the FDA will disapprove this treatment, it clearly highlights what regulators will scrutinise when evaluating psychedelic therapies. For Lykos, the decision was disappointing, but for others, it has provided invaluable insights into what will be needed to bring psychedelic treatments to market. This article distils the key actionable lessons on designing and delivering psychedelic trials to meet regulatory standards.

As a CRO specialising in psychedelics, we're currently engaged in nine trials encompassing a variety of drugs and therapy modalities, ranging from intensive therapy sessions to minimal psychological support. Broadly, these trials fall into two approaches: one aims to maximise efficacy by integrating therapy with the drug, while the other seeks to isolate the drug's effects by minimising therapy. Through these trials, we can discern what approaches yield favourable results and which do not.

Discover the latest strides in the realm of Treatment Resistant Depression (TRD) research in our latest blog. Join Dr. Iain Jordan, our Clinical Director, as he provides a comprehensive overview, delving into discussions on current treatments and unveiling the cutting-edge clinical research underway at Clerkenwell Health.

In recent years, significant strides have been made in the medical field regarding treatments for post-traumatic stress disorder (PTSD), notably in the use of entactogens like MDMA (commonly known as ecstasy) and methylone to aid therapy. For individuals whose lives have been profoundly impacted by PTSD, these advancements offer additional options, especially when traditional treatments like psychotherapy and medication are not enough.   

In most countries, clinical trials are the only way to receive psychedelic therapy in a medical setting. If you’re interested in participating in one but not sure how, this guide will walk you through what you need to know.