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MDMA therapy for PTSD granted innovation passport by UK

World-leading MDMA research organisation MAPS has been granted the passport under the UK’s new scheme.



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The Multidisciplinary Association for Psychedelic Studies (MAPS) has been granted the Innovation Passport for MDMA as an adjunct to therapy for post-traumatic stress disorder (PTSD).

Patients in the UK may see early access to MDMA as a therapy for PTSD. MDMA, administered as an adjunct to-trauma-focused therapy for PTSD, is currently being investigated through trials sponsored by MAPS and MAPS Europe B.V., with support from MAPS Public Benefit Corporation (MAPS PBC). 

The passport has been granted under the UK’s new Innovative Licensing and Access Pathway (ILAP) scheme which aims to accelerate the approval timelines for medicines.

This will enable MAPS PBC to co-ordinate its clinical trial design with the Medicines and Healthcare products Regulatory Agency (MHRA), creating a road map for early patient access to the therapy.

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Chief medical officer of MAPS PBC, Corine de Boer, M.D., Ph.D., commented: “In the last two years, we have all lost so much—an experience reflected in increasing rates of symptoms of serious mental health conditions. 

“For many people who live with PTSD, an already-urgent need has been exacerbated by strains on healthcare systems, isolation, and loss of a sense of security. 

“Despite the profoundly devastating effects of PTSD, few effective treatments are available. We commend the MHRA for recognising the seriousness of PTSD, a life-threatening condition with a profoundly unmet public health need, and the potential of MDMA-assisted therapy to be part of the solution.”

The scheme was launched in January 2021 in a bid to reduce the time to market for innovative medicines. As part of the scheme, the innovation passport enables successful applicants access to support at all stages of the design, development and approvals process, and the chance to gain regulatory and stakeholder input – although this does not guarantee approval by MHRA.

PTSD in the UK

There are currently limited treatment options for PTSD, meaning there is a desperate need for new ones.

In the UK in 2015 it is estimated that 3 per cent of people were living with PTSD – a condition which can be caused by traumatic events from military and combat service, to abuse, neglect and natural disasters. Symptoms include hypervigilance, insomnia, intense feelings of guilt or shame, apathy and avoidance responses, which can exacerbate isolation. 

Left untreated, these symptoms can cause an increase in susceptibility to mood, anxiety and substance use disorders; suicidal ideation or attempts; autoimmune disorders such as arthritis and asthma; congestive heart disease and hypertension; ulcers; and epilepsy or neurologic disorders.

MDMA releases oxytocin, vasopressin, and prolactin – neurohormones linked with trust and bonding – and decreases activity in the amygdala, the region of the brain corresponding with fear and traumatic memories. 

These unique effects are thought to contribute to MDMA’s effectiveness as a catalyst to therapy for people living with PTSD. No drug is without risks, so clinical trials have included careful investigation of possible adverse effects. Thus far, no serious unexpected safety signals have emerged and side effects have been found to be temporary and manageable in a clinical setting.

Early patient access to MDMA therapy

Any medicine granted an innovation passport under the new scheme must meet a number of criteria including being developed for a life-threatening or debilitating condition; having significant patient or public health need; and, having potential benefits to patients, for example. 

Key partners of the scheme include MHRA, National Institute for Health and Care Excellence (NICE), the All Wales Therapeutics and Toxicology Centre and the Scottish Medicines Consortium (SMC). NHS England and NHS Improvement, Health Research Authority (HRA) and the National Institute for Health Research (NIHR) are also additional supporting partners.

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The ILAP designation, authorised by a steering group of representatives from the key partners, has acknowledged that adjunct MDMA therapy may have unique potential as a safe and effective treatment for PTSD.

“This innovative approach to innovative treatments aligns key regulatory and healthcare systems across the UK to ensure all of the stakeholders who will be involved in making a treatment accessible are represented,” stated Berra Yazar-Klosinski, Ph.D., chief scientific officer at MAPS PBC.

“Our promising Phase III results lead us to apply for the Innovation Passport.

“The ILAP Innovation Passport will ensure MDMA as an adjunct to therapy can be made widely available, as rapidly as possible, for the UK PTSD patients who need it.”

As part of the adjunct MDMA therapy, preparatory and integration sessions are combined with three MDMA sessions, spaced a month or more apart – all administered by specially trained clinicians. 

The treatment takes up to three months to complete and does not require ongoing medication. In the Phase III trial conducted in the United States, Canada, and Israel, 88 per cent of participants who received MDMA experienced a clinically significant reduction in symptoms, and 67 per cent no longer qualified for a PTSD diagnosis.

A total of 71 application have been submitted for the scheme so far, and MAPS is one of only 41 applications to have been successful.

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Integrating metaphysics into psychedelic therapy



Integrating metaphysics into psychedelic therapy

Dr Peter Sjöstedt-Hughes, Lecturer at Exeter University, has proposed incorporating metaphysical philosophy into psychedelic therapy to help improve therapeutic outcomes.

Sjöstedt-Hughes suggests that psychedelic therapy may gain more advantage by extending its scope into metaphysics, helping patients better integrate and understand psychedelic-induced metaphysical experiences.

Such improved outcomes may be seen if patients undergoing this therapy “are provided with an optional, additional, and intelligible schema and discussion of metaphysical options at the integrative phase of the therapy.” 

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In the paper, Sjöstedt-Hughes puts forward this schema as the “Metaphysics Matrix” and an accompanying “Metaphysics Matrix Questionnaire (MMQ)” which can be utilised by therapists and researchers as a tool for the quantitative measurement of a psychedelic experience.

The paper ‘On the need for metaphysics in psychedelic therapy and research’ has been published in Frontiers in Psychology.

What is metaphysics?

While mysticism deals with understanding the universe through direct experience, such as revelation, metaphysics is a branch of philosophy that deals with understanding the fundamental nature of reality through logic/argument.

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Sjöstedt-Hughes writes that “metaphysics is not mysticism” but there is overlap: “[…] metaphysics is broader and its positions can be logically deliberated — as such metaphysics can encompass mystical experiences induced by psychedelic intake yet metaphysics can also ground those experiences in a manner that can be more intelligible, comprehensive, viable, and acceptable to participants than that which the framework of mysticism alone can offer.”  

The Metaphysics Matrix

A number of clinical trials investigating psychedelic-assisted psychotherapy for the treatment of mental health conditions, such as anxiety and depression, report that participants who undergo a “mystical experience” during a psychedelic session often have higher levels of sustained therapeutic outcomes.

In clinical trials, mystical experiences are measured by different scales including the Mystical Experience Questionnaire (MEQ), the Hood Mysticism Scale (HMS), the Hallucinogen Rating Scale (HRS), the Five Dimensions Altered State of Consciousness Questionnaires (5D-ASC) and Eleven Dimensions Altered State of Consciousness Questionnaires (11D-ASC).

Sjöstedt-Hughes writes: “Data derived in this manner is obviously limited and abstract not only because psychedelic experience need not be “mystical,” but also because the definition of “mystical” could be expanded to include other criteria [

“With regard to psychedelic-assisted psychotherapy […] speaking about mystical experience per se will not be sufficient to provide a meaningful explanation of the significance of such experience to a person, for the simple reason that mystical experience is the phenomenon to be explained — mystical experience is the explanandum rather than the explanation. 

“It is metaphysics that is the means of explanation, the explanans of the mystical explanandum.”

The Metaphysics Matrix has been designed to provide a “menu” of metaphysical options that may help people to “frame, make sense of, and give significance to, their experiences”, and would be another tool in the belt of therapists to better understand these experiences.

Image provided by Dr Peter Sjöstedt-Hughes.

Such experiences could be understood through metaphysical systems such as Neutral Monism, Pantheism, Panpsychism, Animism, Substance Dualism, and Idealism, says Sjöstedt-Hughes. 

Some examples provided include the common experience of the Universe being God – which can be understood in the context of Pantheism – or of all matter having a basic form of sentience – such as plants having a basic drive or process – which can be understood in the context of Panpsychism. 

Image provided by Dr Peter Sjöstedt-Hughes.

Additionally, enabling people who have had these experiences to understand them within these frameworks may make them less likely to dismiss the experiences as delusional, says Sjöstedt-Hughes.

“ […] Relatedly, that the worldview hitherto adopted by the participant is but one metaphysical position amongst others,” he writes. 

Sjöstedt-Hughes commented: “This is a conjecture that hasn’t been tested but can be tested – offering a patient an additional and optional discussion in the integrative phase of psychedelic-assisted psychotherapy. 

“Giving them this Metaphysics Menu for integration may extend the long-term benefits of psychedelic therapy and beyond because there’s a number of studies that seem to show that certain peak psychedelic experiences have the longest and most beneficial health outputs results.

“If in the integrative phase [of therapy] one looks at that experience and starts to frame it intelligibly, then the conjecture is that the participant will not in a few weeks after that, think it must have been a delusion – they will say that we don’t know what reality is. 

“Therefore, we can’t dismiss something as a delusion necessarily. By doing that it might extend the significance of that experience for the person.

“When we use Mysticism Scales, by definition, mystery can’t explain itself. Metaphysics, however, incorporates those experiences and offers an explanation to what they mean. For example, the relation between oneself and the universe.”

Sjöstedt-Hughes points out that in practice, one of the immediate issues is the practical issue of implementation of Metaphysics Integration, suggesting this could be supported through resources such as a handbook or practitioner training.

He further concludes the integration would need to be “further bridged by the therapist to the participant’s life, concerns, values, aims, and outlook.”

The Metaphysics Schema is already being utilised in studies taking place at Ohio State University, US, and Exeter University, UK.

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Ketamine nasal spray for anxiety and PTSD advances



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Silo Pharma has announced it has advanced the formulation development for its therapeutic drug, SPC-15, which utilises ketamine.

The liquid nasal formulation will be used in SPC-15’s novel protocol that aims to treat and prevent anxiety, post-traumatic stress disorder (PTSD), and other stress-related disorders. 

Chief Executive Officer of Silo Pharma, Eric Weisblum, stated: “The progress of our feasibility study investigating dose strengths of SPC-15 is a significant advancement in our development work with this pipeline candidate.

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“Results of the feasibility study will determine our selection of the manufacturing processes, and we are currently in discussions with potential delivery partners.

“We may also use the feasibility data for upcoming studies related to our SPC-14 therapeutic targeting Alzheimer’s disease.”

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The company has stated that the formulation development was in accordance with its sponsored research agreement and option with Columbia University, and that linearity, accuracy, and repeatability were achieved in the feasibility study.

In May 2023, Silo Pharma was awarded a U.S. Patent titled “Biomarkers for Efficacy of Prophylactic Treatments Against Stress-Induced Affective Disorders,” with claims protecting the key technology behind SPC-15 and further drug discovery.

The company is also carrying out a Sponsored Research Agreement with the University of California, San Francisco (UCSF) – Effect of Psilocybin on Inflammation in the Blood – which is investigating psilocybin’s effect on inflammatory activity in humans, with plans to accelerate its implementation as a potential treatment for Parkinson’s, chronic pain and bipolar disorder.

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How psychedelics could help those living with alcohol use disorders



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Alcohol use disorders (AUD) are estimated to affect around 237 million people across the globe, with 3 million deaths each year attributed to the harmful use of alcohol.

Despite this prevalence, there is a lack of effective treatment options and relapse rates remain high, but hope is on the horizon in the form of clinical research that is starting to show the therapeutic potential of psychedelic compounds for problematic drinking.

AUD affects millions of people around the world. In fact, approximately one in every 20 deaths globally are in some way related to alcohol, be it through disease, injury, or accident. There are over 600,000 dependent drinkers in England alone, and, in the US, roughly a third of people meet the criteria for AUD on a lifetime basis. Sadly though, only 21.9% of patients across the globe receive treatment for AUD and many struggle with relapse. 

Why is this? Well, put simply, the treatment landscape for AUD is incredibly complex and there are many barriers throughout the treatment pipeline. Whether it’s the mental barrier of actually wanting to stop drinking, physical dependence, fear of withdrawal symptoms, the lack of awareness of what support is actually available, or the cost of treatment, it can be difficult for people living with AUD to know what to do.  

And even if they are screened by a healthcare professional, the treatments available may not be effective for them. There may be undesired side effects and up to 70% of people taking pharmacological treatments for AUD find no positive outcomes. This means there is a huge unmet need for better, more effective and more accessible treatments – and this is where psychedelics come in. 

How psychedelics are offering hope to those that struggle most

Thanks to a growing body of research, psychedelics have become a new medicine of interest for those looking to ease the burden substance use disorders have on individuals, families and healthcare systems. Psychedelics are believed to work by inducing a ‘window of neuroplasticity’ in the brain, which opens up the possibility for new behaviours or patterns of thinking to be developed. It is this ability that makes psychedelics so interesting in the case of treating conditions like AUD where addiction-related habits and emotions play a huge part.

The science is promising. In the U.S, a recent study led by the New York University Grossman School of Medicine showed that psilocybin treatment improved drinking outcomes in patients with AUD relative to outcomes observed with a placebo medication. Specifically, the study found that two doses of psilocybin, when combined with psychotherapy, reduced heavy drinking by 83%. Another study found that ibogaine, a psychedelic derived from the roots of a West African shrub, when used in conjunction with psychotherapy, could increase periods of abstinence in those with alcohol and other substance addictions. 

At Beckley Psytech, we’re exploring the potential of our synthetic formulation of 5-MeO-DMT, BPL-003, for AUD in a Phase IIa study. Phase I healthy volunteer data has already shown that BPL-003 is well-tolerated and can reliably induce profound subjective experiences (a correlate of positive clinical outcomes) with a rapid onset and timely offset of perceptual effects. The Phase IIa study will explore the safety, efficacy and pharmacokinetics of BPL-003 alongside an abstinence-oriented cognitive behavioural programme in patients diagnosed with AUD. Topline results are expected later this year.

Collaboration is critical

It is, of course, still early days but the science seems to be indicating that psychedelics, when administered in the right context and with the right support, can help those who are suffering from a range of mental health conditions. With clinical studies progressing, and approval for other psychedelic treatments expected in the next few years, now is the time to develop the infrastructure that will allow us to actually deliver these interventions to people living with AUD. This involves us all: patients, regulators, investors, healthcare professionals and drug developers.

At Beckley Psytech, we are always looking to hear from others in the space so please head over to to learn more about our work in AUD and how to get in touch.

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