Fuente: Prohibición Partners Lugar: General Contents

Report Overview
The Medicines (Deep Dives)
Consumer Attitudes
Health & Science
Legal Landscape
Industry Voices





Introduction



Stephen Murphy, Managing Director, Prohibition Partners



PSYCH, by Prohibition Partners, is proud to bring you the second edition of PSYCH: The Psychedelics as Medicine Report, profiling all major psychedelic drugs, both naturally derived plant-based varieties (entheogens) such as psilocybin, ibogaine, ayahuasca and mescaline, along with those synthetically manufactured in laboratory settings, such as LSD (lysergic acid diethylamide), ketamine and MDMA (Methylenedioxymethamphetamine).



Still in the midst of the threat of COVID-19, it feels for many of us as though the world has changed immeasurably since Prohibition Partners first launched PSYCH in early March. It may be some time before the wider impact of this pandemic is fully understood, but one thing is certain: the need for novel and effective therapies for the treatment of mental health conditions such as depression, anxiety and PTSD is greater now than ever before.



Psychedelics may provide the solution many patients are looking for. Once the darling of the medical community, psychedelics fell out of favour when they were adopted by the ‘hippie’ counterculture of the 1960s. Their status as illicit substances was then codified in the Convention on Psychotropic Substances of 1971. In 2020, however, psychedelics are experiencing a radical renaissance.



Our fully updated report identifies the changing legal and regulatory frameworks within which psychedelics are currently controlled. It provides expert analysis of the overwhelming evidence from advanced clinical trials, which supports the potential of each of the psychedelics profiled to disrupt conventional treatments for a wide array of debilitating mental health conditions, affecting hundreds of millions of people worldwide.



Finally, it offers key insights into the extraordinary opportunities that psychedelics will present to early movers in this nascent industry, including interviews with pioneering experts already operating in the therapeutic psychedelics space.



Executive Summary



In the 1950s and 1960s certain psychedelics, such as psilocybin and LSD, showed early promise in the treatment of a variety of mental health disorders. However, psychedelics soon fell out of favour with the medical research community when they were adopted by the ‘hippie’ counterculture of the time. The majority were classified as controlled substance (Schedule 1) drugs under the Convention on Psychotropic Substances, 1971.



Despite this, and perhaps as a result of the normalising influence of cannabis in medicine, psychedelics are currently experiencing a ‘renaissance’ as their potential to treat a wide variety of health conditions is recognised. In fact, psychedelics are already on course to become the next major innovation in treating the global mental health pandemic.



This report examines five psychedelic substances in depth. These are: psilocybin (‘magic’ mushroom), LSD, ketamine, MDMA and ibogaine.



Key Findings on Substances:




Psilocybin: The psychoactive substance in so-called ‘magic’ mushrooms has shown promise, along with other psychological supports (such as talk therapies) in the treatment of treatment-resistant depression or TRD (depression that does not respond to conventional antidepressants and that is estimated to affect more than 100 million people worldwide). Two separate providers, COMPASS Pathways and the Usona Institute, have received breakthrough therapy designation (BTD) from the US federal FDA for synthetic substances derived from psilocybin for use as part of psychedelic assisted psychotherapy for TRD and major depressive disorders respectively.



LSD: Has shown tremendous early potential in the treatment of depression, anxiety, schizophrenia and, most recently, Alzheimer’s disease, among others.



Ketamine: The only psychedelic profiled in this report that features on the World Health Organization (WHO) list of essential medicines. Ketamine is widely available as a general anaesthetic. It can also be used ‘off label’ (for purposes other than anaesthesia, which have not been approved) for the treatment of conditions as varied as depression, anxiety, suicide ideation, chronic pain and fibromyalgia, available in ketamine infusion clinics throughout the US and is being tested in the UK and Ireland. Esketamine, one half of the ketamine molecule is the only FDA and European Medicines Agency (EMA) approved psychedelic medicine for the treatment of TRD.



MDMA-assisted psychotherapy: Is showing incredible promise for the treatment of PTSD. So much so that it is expected to receive FDA approval by 2022, having received breakthrough therapy designation in 2017. The therapy has been so effective that a small study conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS) found that two thirds of the study participants who completed a course of MDMA-assisted psychotherapy no longer met the criteria for a PTSD diagnosis up to 12 months after treatment.



Ibogaine: Originates from West Africa and has been used in the treatment of SUDs in countries such as Mexico for decades26. Ibogaine has shown potential to decrease a patient’s misuse of stimulants, opiates and alcohol, and to reduce symptoms of withdrawal (from opiates) after the administration of a single dose27.




The Market Context



There are inevitable parallels and similarities between psychedelics and cannabis—both are naturally derived and plant based, with most psychedelics classified as Schedule 1/Class A drugs, as is cannabis28. However, psychedelics as a category have the upper hand on cannabis in relation to treatment potential29.



The psychedelics industry is a fledgling market that is set to expand exponentially in the next number of years, albeit from a low starting base30. With depression on the rise, increasing awareness of the detrimental impact of mental health disorders, and the emergence of new treatment therapies, the global market for alternatives to conventional antidepressants is sizable31.



Prohibition Partners estimates that psychedelic-assisted therapies could provide relief in costs to society in the region of US$150 billion in relation to SUDs (opioid, alcohol and nicotine), almost above US$150 billion in relation to depression and US$12.4 billion in relation to PTSD, for just the US and EU32.






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