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Deregulating Psychedelics To Propel Clinical Research

Pink and yellow psychedelic sun pattern.
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The following article is an opinion piece written by Colin Callaghan, Hugo Geerts and Patrick Loebs. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official position of Technology Networks.

When lawmakers who hold diametrically opposing viewpoints on most issues come together to sponsor a piece of legislation, it signals that the proposed law holds significant potential for tangible public benefit. That’s why when US Senators Cory Booker (D-N.J.) and Rand Paul (R-KY) introduced the Breakthrough Therapies Act, it made news.


If passed, the legislation would allow the deregulation of designated breakthrough therapies. Schedule I controlled substances such as MDMA and psilocybin (more commonly known as ecstasy and magic mushrooms, respectively) would be reclassified to Schedule II, a category with fewer restrictions that permits medical use. This, alongside other provisions in the bill, would remove burdensome federal regulations that impede the research and development of treatments using psychedelic drugs.


Legislation that lowers barriers for the use of psychedelics in medical research surprised many observers. But, because of the potential benefits of these drugs, deregulation of psychedelics has taken place recently in Australia and Canada. Regulatory and legislative bodies around the world are moving toward deregulation for research purposes, and we believe that should happen quickly.


Psychedelics are in the spotlight once again

Though they have long been regarded in North America and Europe as harmful, psychedelics could become an alternative to traditional therapies used historically to treat depression, anxiety and post-traumatic stress disorder (PTSD) that don’t work for everyone and have untoward side effects.

Research shows psychedelics to be efficacious, safe alternatives to existing antidepressant and anti-anxiety medications that hold promise for treating those who are treatment-resistant or non-responsive to current therapies. Many of these individuals are part of the ex-military population dealing with the debilitating effects of PTSD, which has a direct impact on the high incidence of suicide among veterans.

In addition, and more recently, COVID-19 has affected the mental health of millions, creating isolation and exacerbating certain mental health conditions. Psychedelics could help.


There are other reasons for the renewed interest. Psychedelics have been used as sacramental tools in many religions and cultures for thousands of years. Decades of anecdotal information and published research show that these natural substances are generally safe, despite how they are viewed in popular culture.

Modern research shows acceptable tolerability, particularly at the doses that are being evaluated clinically. In real-world use, cases of severe toxic effects of psilocybin or LSD are extremely uncommon, a very rare example in drug development. Nevertheless, rigorous, adjudicated clinical research is needed to determine safety and provide a scientific basis for advising and treating patients.


In addition, there are increasing biological insights on the impact psychedelics may have on the brain’s neuroplasticity that are highly encouraging. Early evidence suggests that psychedelics can fundamentally change neural pathways, neural growth and connections in the brain in a positive way; by combining psychedelic-based pharmacotherapy with behavioral therapy, it could bring about long-lasting changes in how the brain functions.


The first steps towards a clinical revolution

Modeling and simulation studies conducted for interventions in Cognitive Impairment Associated with Schizophrenia (CIAS) showed a synergistic effect when behavioral therapy was combined with pharmaceuticals, allowing the opening of new neural pathways to fight the condition and improving brain plasticity.

Some companies are developing AI-based, digital therapeutics to durably retrain neural pathways to address mental and behavioral health conditions; it is possible that psychedelic-based pharmaceutical treatments could be an effective part of this emerging treatment paradigm.


What must happen next to bring forward the benefits of psychedelics to address unmet patient need is already underway and needs to continue. The generation of scientifically sound, high-quality data, whether submitted to regulators or published freely, will move the needle. Deregulation of psychedelics scheduling will accelerate the gathering of that data and enable more researchers to be involved in drug development.


The mounting pressure on regulatory and policymaking bodies to address the unmet needs of patients afflicted with major depression, anxiety, PTSD and other conditions that too frequently lead to suicide is driving forward movement.

In June 2023, the US Food and Drug Administration (FDA) issued the draft guidance Psychedelic Drugs: Considerations for Clinical Investigations for public comment, signaling a trend of renewed interest in the therapeutic benefit that these drugs can offer. In July, the Therapeutic Goods Administration, Australia’s drug regulatory agency, permitted prescription, under certain conditions, of MDMA and psilocybin for PTSD and treatment-resistant depression, respectively - the first time a country has allowed the prescribing of psychedelics.

Similar efforts are underway in Canada and under consideration in the EU. If the US passes the Breakthrough Therapies Act, a major shift in psychedelic therapeutic development will occur.

More than 80 companies are developing psychedelic-based drugs now to treat difficult-to-treat diseases like major depressive disorder and substance use disorder. Currently, it's cost-prohibitive for most startups to move to clinical research, but with the approval of this legislation, that will quickly change.

One company, MAPS-PBC, submitted the first NDA for any psychedelic-assisted therapy, in this case for MDMA to treat PTSD, recently in December 2023. Another company, Compass Pathways, is currently in phase 3 development investigating the use of psilocybin to address treatment-resistant depression. How the FDA responds to their data and what kind of post-marketing requirements they set will create precedents in this relatively uncharted area.


An uncertain future

Despite this forward movement, psychedelic drug developers are fighting against persistent headwinds, including the legacy of legislation from the early 70s when all scientific investigation into these compounds was stopped and they were moved to Schedule I, a classification that was globally adopted by the UN.


With that stigma, exacerbated by the language of the war on drugs, viewing psychedelics as legitimate treatment options will be a hard turn for many. But thought leaders in the pharmaceutical industry, academia, governments and healthcare are speaking up, supported by current, scientifically sound, high-quality data.


Psychedelics may seem like a departure from the more traditional mental health therapies, but there’s more that’s the same in their emergence as is in the development of any other drug. Rigorous regulations and approval criteria from the FDA dictate that psychedelics must be tested, and proven to be safe and effective, just like any other drug candidate.


Finally, the testimonials from patients, many of whom are unresponsive to other treatments, are very compelling. With psychedelic therapy, patients struggling with PTSD, substance abuse disorder, depression and suicidal ideation are finding relief from their symptoms and are able to enjoy life.

Making psychedelics available for research is not only about staving off the mortality associated with suicide, but also about restoring quality of life, improving people's outlook and increasing their ability to productively and happily function.


We need to change the narrative about psychedelics, and the Breakthrough Therapies Act must be passed. It would enable the US Drug Enforcement Administration to reclassify psychedelics from Schedule I to Schedule II for clinical research purposes. That would be the impetus for drug developers to move forward with research that may result in therapeutics that can treat those who are suffering and for whom the current standard of care isn’t working. It is clear that multiple stakeholders across private and public institutions have one thing in common: they want to champion psychedelics to save lives.

About the authors: 


Colin Callaghan has over 30 years of experience in both biotechnology and pharmaceutical companies with an emphasis on treatments for mental illnesses. He is a senior director of R&D Program Leadership in Certara’s Integrated Drug Development Solutions practice area.


Hugo Geerts is co-founder of In Silico Biosciences (ISB), which integrated mechanistic quantitative systems pharmacology modeling with computational neurosciences to support R&D projects in Alzheimer’s and Parkinson’s disease and in schizophrenia. He is head of Neuroscience Quantitative Systems Pharmacology at Certara, and worked for 17 years at the Janssen Research Foundation, where he identified galantamine for Alzheimer’s Disease and supported its successful clinical development.


Patrick Loebs has over 35 years of product development experience in the pharmaceutical, CRO, biotech and academic space and is a director at Certara. He has held positions in regulatory affairs, regulatory operations, medical writing, clinical operations and program management. Most recently, he managed the development of two transgenic recombinant products that treat blood disorders.