New highs for psychedelics in the clinic

Psychedelic compounds have long been experimented with for their mind-altering properties, but in recent years, this theme of research has taken on a much more serious demeanour.  It may be that taking a “trip” to the doctors could soon acquire an additional meaning.

First ever FDA new drug application for psychedelics 

The Multidisciplinary Association for Psychedelic Studies (MAPS) is at the forefront of this area. MAPS recently released Phase III clinical trial results showing a significant impact of the use of MDMA (also known as ecstasy) in the treatment of patients with post-traumatic stress disorder (PTSD). 

Part of the appeal of using psychedelics to treat difficult psychological conditions like PTSD is that they allow a patient to enter an altered state of consciousness. MDMA is thought to soften responses to emotionally challenging and fearful stimuli and therefore to enhance the ability of individuals with PTSD to benefit from psychotherapy by reducing sensations of fear, threat and negative emotions.

In the MAPS clinical trial, patients in the treatment arm received a dose of 120 to 180 mg of MDMA alongside psychotherapy conducted by trained personnel and they underwent three treatments spaced apart by approximately one month. This intervention was found to lead to a statistically significant reduction in a diagnostic score for assessment of PTSD severity compared to placebo.

MAPS’s positive trial results have culminated in the first ever new drug application to the US Food and Drug Administration (FDA) for a psychedelic-assisted therapy.  Moreover, as PTSD is a serious condition with few good treatment options there is a good chance that MAPS’s submission to the FDA will be granted accelerated review as a “breakthrough” therapy.  This could mean that a decision on approval could be as early as Summer 2024.

… And other drugs

Aside from the advance in MDMA related therapies, other psychedelics are also deep into the clinical study phase. Indeed, in the last 5 years or so, there has been a huge uptick in the number of registered clinical trials which relate to a psychedelic pharmacological intervention.  

For example, lysergide d-tartrate (more commonly known as LSD) is part way though clinical trials looking into the treatment of generalised anxiety disorder and has shown potential positive benefits at a dose of 100 µg. Mindmed, the company that ran the trial are analysing the data further before considering whether to continue with a Phase III trial. Psilocybin (the active compound in magic mushrooms) has also been shown to have a significant impact for patients with treatment-resistant depression in a phase II study. 

Interestingly, many of the currently ongoing trials are directed towards chronically underserved and difficult to treat conditions such as anorexia, substance abuse, psychosis, OCD, and autism.

Hurdles and high-jump

It is worth noting that one of the difficulties in the clinical study of psychedelics is “blinding” the treatment and placebo arms to reduce bias in the results. Due to the nature of the therapy many subjects are able to correctly guess which arm of the study they are in. This could potentially cause some hesitancy for regulatory bodies like the FDA.

Nevertheless, if MAPS is successful in obtaining FDA approval for their MDMA adjunctive therapy, then it is highly likely that this upward trend in psychedelics research will continue and perhaps even accelerate.