Psychedelics were used for medicinal purposes throughout history before being classified as illegal drugs in the 1960s. But that’s changing now, with psychedelics gaining widespread attention as rigorous clinical studies have shown their potential as a treatment for unmet mental health needs. What explains this renaissance, how soon will we see psychedelics on the market, and most importantly, where does Big Pharma stand on this? let’s find out
The US Food and Drug Administration (US FDA) and European Medicines Agency (EMA) approved Johnson & Johnson’s Spravato (esketamine) for treatment-resistant depression in 2019, the first approval of a psychedelic treatment for a psychiatric disorder in both the United States and in the US European Union. Esketamine is derived from the anesthetic ketamine. This opened the floodgates to interest in psychedelic space. To date, two psilocybin-based drugs have received breakthrough designation from the FDA – the UK’s COMPASS Pathways for treatment-resistant depression and the US’ Usona Institute for major depressive disorders.
This, coupled with the fact that mental health disorders have grown exponentially, but the development of novel drugs has not kept pace. Drugs such as MDMA (3,4-methylenedioxymethamphetamine), psilocybin and LSD (lysergic acid diethylamide) have traditionally been considered recreational drugs but are increasingly being used in medical research.
A report by Research And Markets states that the market size for psychedelic drugs is expected to reach US$10.75 billion by 2027, up from US$4.75 billion in 2020, with a CAGR of 12.36 percent during 2021 -2027.
“The whole field is advancing in industry and science, and many new groups in neuropsychopharmacology around the world are developing and using techniques from animal models to human studies with MRI to map neural networks to better understand the mechanisms of action. Add to this the psychotherapeutic research and training to better use these methods in combination with psychoactive compounds to achieve results beyond the use of the drug alone. I think that R&D is reaching a critical mass and really impactful innovations are not that far away,” said Dr. Nathan Bryson, Chief Scientific Officer at Field Trip Health Canada.
Unleashing the potential of psychedelics
Research and development in psychedelic medicine and therapies has enjoyed a renaissance in recent years, resulting in key data proving its potential to treat a wide range of mental health indications, including cancer-related distress, depression, anxiety, addiction and more.
“People often forget that there has already been more than five decades of psychedelic research. This research was conducted by world-class institutions including Johns Hopkins in the US, NYU, King’s College in the UK, the University of Toronto in Canada, and Imperial College in the UK. Recently, research in this area has received increased attention for several reasons. First, the mental health problem — which was already a major concern — is now at epidemic levels, exacerbated by the impact of COVID-19. Second, attitudes towards mental health have evolved and matured to the point that it is now “okay not to be ok.” More and more people are seeking treatment and are interested in alternatives to traditional medicines – whether because they are concerned about side effects of medicines such as weight gain or sexual dysfunction, addiction or other undesirable consequences. A third driver is the development of public order in this area. We are seeing a push to decriminalize certain restricted connections in various jurisdictions. We see a demand for more compassionate use – particularly in relation to end-of-life exceptions for psychedelic assisted therapies. We’re even seeing the Drug Enforcement Administration in the US increasing the limits on the amount of these compounds researchers can hold. These forces have led to the “Shroom Boom,” with many new companies pursuing a variety of indications, including anxiety, depression, post-traumatic stress disorder (PTSD), and substance abuse. These companies have attracted investors and new capital has flowed into the psychedelics research business, leading to an acceleration in the number of ongoing studies,” said Tim Moore, CEO of HAVN Life, Canada.
HAVN Life Sciences is a biotechnology company aiming for standardized extraction of psychedelic compounds to produce API.
Over the last several decades, psychedelics have been the subject of decades of research conducted by select academic researchers and a small number of non-profit groups, with the goal of establishing the safety of psychedelics, along with some preliminary efficacy data demonstrating their potential to treat neuropsychiatric and mood disorders.
“In recent years, investment capital has begun to flow into for-profit ventures established with the goal of developing psychedelics into approved therapeutics by advancing them along established regulatory pathways. These efforts have focused primarily on formulations of known psychedelic drugs that are in the public domain. Based on this research effort, MDMA and psilocybin have made significant strides toward FDA approval for use in the treatment of post-traumatic stress and treatment-resistant depression,” said James Lanthier, Chief Executive Officer (CEO) of Mindset Pharma, Canada.
Mindset Pharma was founded to discover and develop “next generation” psychedelics that are chemically novel and optimized to address some of the shortcomings of “first generation” psychedelics. In January 2022, Mindset partnered with Otsuka Pharmaceuticals of Japan, marking the first entry by a global pharmaceutical company into the emerging field of psychedelic medicines.
The most advanced programs are the American Non-Profit Multidisciplinary Association for Psychedelic Studies (MAPS) successful Phase III trial of MDMA in post-traumatic stress disorder and the UK Compass Pathways COMP360 (psilocybin) with a positive Phase 2b in treatment-resistant depression.
“We expect MDMA to be approved for the treatment of PTSD by 2023 and for the treatment of addiction by 2025,” said Anthony Tennyson, CEO of Awakn Life Sciences, Canada, a biotechnology company exploring psychedelic therapeutics to better treat addiction. develops and delivers.
Apart from that, 13 other candidates are in phase II studies and 12 in the initial phase of the study (I). Most of these compounds are being researched to treat different categories of depression.
Where is Big Pharma?
In January 2022, Japanese company Otsuka Pharmaceutical signed a deal with Canadian company Mindset Pharma to support the development of psychedelic drugs. This is the first-ever deal by a major pharmaceutical company in this space. While Big Pharma has invested fully in the cannabis sector of late, it hasn’t shown the same interest or investment in psychedelics.
“The ‘big pharma’ industry is currently evaluating the merits of biology, science and quality of ongoing research at academic centres, non-profit and commercial organisations. A number of advanced programs are currently leading the way to demonstrate significant benefits for patients and value for investors. Most psychedelics companies are unable to generate any revenue as they participate in clinical trials to prove the compounds work for specific diseases. Once positive data is generated, big pharmaceutical companies are expected to take notice, followed by investment actions, which was recently the case for Tokyo-based Otsuka Pharmaceutical,” said Dr. Bob Dagher, Chief Medical Officer at Enveric Biosciences, USA.
Enveric Biosciences is developing next-generation mental health and oncology supportive treatments and a clinical discovery platform utilizing psychedelics-derived molecules for the mind and synthetic cannabinoids for the body.
While the cannabis sector had a head start, both the healthcare industry and the general population are now embracing psychedelics as the next generation of mental health treatment, with growing acceptance and changing public perception.
“In 2020, Oregon, United States, passed Measure 109 — a vote allowing for the regulated use of psilocybin in a therapeutic setting. This was a milestone for psychedelic medicine as it paved the way for safe and legal treatment in this area. That being said, it is clear that there is interest from the big pharmaceutical companies, however we should expect a gradual acceptance as new and positive research results are published”, said Dr. dagher
Despite the promising early research on psychedelics, their regulatory status has meant that large pharmaceutical companies have had few incentives to conduct the research necessary to develop psychedelics into medicines. This coupled with the fact that the most clinically advanced molecules like psilocybin are not patentable.
“That makes these compounds less attractive to big pharmaceutical companies. Typically, big pharmaceutical companies wait for clinical evidence before entering into a partnership. The second-generation patent-protected molecules, like ours at Bright Minds, have yet to meet these milestones. Big Pharma, however, is on the sidelines and has begun to meddle. Expect this to accelerate as more clinical data comes in,” said Josh Blacher, vice president, corporate development, Bright Minds Biosciences, a Canadian biotech company dedicated to developing serotonergic therapeutics to treat mental disorders.
“I think there’s still a little too much risk in delivery and economics,” said Dr. bryson
He added: “Today, therapy is a modern version of traditional shamanic practices, with guided sessions to achieve drug-induced introspection, a catalyst for therapy sessions. This delivery model is still in its infancy. In addition, very durable results seem to be achievable with “generic” molecules (psilocybin and MDMA are not patentable). Therefore, it is difficult to understand the pharmacoeconomic model that leads to profitability. I think it will be the arrival of more tailored NCE molecules, designed for purpose, with safety and efficacy, convenience and most importantly patent exclusivity, and ultimately priced to have a positive ROI that will will draw attention from Big Pharma.”
The regulatory system for psychedelics is still patchy and most of these compounds are use-restricted and classified as controlled substances, but the USFDA and other regulatory agencies around the world are working to create a strong regulatory network.
Psychedelic drugs offer a promising new treatment paradigm and will open a new frontier in mental health treatment.