Major breakthrough in the Canadian market for psychedelic-assisted psychotherapies

By James Moore


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There has been a major development in the Canadian market for psychedelic-assisted psychotherapies.

Just last week, Health Canada granted a legal exemption to its drug laws, known as a Section 56 exemption, to four terminal cancer patients, allowing them to use psilocybin-assisted psychotherapy in an effort to relieve their end-of-life anxiety and distress.

This is a watershed moment for the sector, potentially opening a pathway to a multi-billion dollar market opportunity.

The importance of what has happened cannot be understated.

It is the first solid sign from Canadian authorities that official endorsement for psychedelic-assisted psychotherapies is coming.

Evidence-based research, including research approved by Health Canada, is already showing great promise for these ground-breaking therapies to treat a wide range of mental health and addictive disorders.

Psilocybin, in particular, has attracted a great deal of research interest.

An increasing number of studies have shown that this compound, which is found in over 200 species of mushrooms, may deliver truly exceptional results.

For example, researchers from Johns Hopkins University in the United States found that psilocybin produced substantial and sustained decreases in depression and anxiety in patients with a life-threatening cancer diagnosis.

Yet, despite its enormous healing potential, this psychedelic compound remains a controlled substance under Canadian Law, having been banned in 1974.

With such strict restrictions on psilocybin’s supply and use in place, it is extremely significant that Canada’s Minister of Health, Patty Hajdu, approved the Section 56 request.

This clearly marks a thawing in the regulatory stance towards psychedelic compounds and an acknowledgement of the evidence they can be used as legitimate treatments.

This is incredible news for Numinus Wellness Inc. (TSX-V:NUMI, which welcomed August’s news shortly after it was announced:

Numinus is excited about all approaches that can enable safe and evidence-based access prior to psychedelic-assisted psychotherapies being fully integrated into the health care system in canada and beyond.

“We are confident that this week’s announcement by health canada marks the beginning of a shift towards psychedelic-assisted psychotherapies in safe, controlled environments as accepted treatment options. This is no longer a question of if – only when.”

There is very good reason for this.

Numinus (TSX-V:NUMI), just recently, quickly closed the books on a $4 million fundraise with proceeds earmarked for its ‘Compassionate Access’ protocol for developing treatments based on psilocybin and MDMA.

Its goal is to create an ecosystem of health solutions to treat mental health conditions, centred on developing and supporting the safe, evidence-based use of psychedelic-assisted psychotherapies.

Already established as one of the leading pioneers in this exciting new field, Numinus (TSX-V:NUMI) had positioned itself in anticipation of a development like this.

Perhaps it has come about quicker than expected, but now that the Canadian authorities have leapfrogged their U.S. counterparts, where psychedelic therapies are similarly gaining growing acceptance by regulators, Numinus (TSX-V:NUMI) is on course to become one of the big winners in the psychedelic market.


Compassionate Access protocols – the key to Numinus’ (TSX-V:NUMI) long-term success

To appreciate how significant Health Canada’s Section 56 ruling is for Numinus (TSX-V:NUMI), it would help to understand a little of what has happened recently in the United States.

“Expanded Access” is a program operated by the Food & Drug Administration (“FDA”) that provides patients suffering from life-threatening conditions with access to investigational drugs prior to their formal approval as legitimate medicines.

The idea is to allow access to promising medications that have not yet been through final phase 3 trials when all other treatments have failed.

Expanded Access programs thereby allow for limited patient access while also aiming to collect outcome and safety data that can be placed along clinical trial data and inform ultimate formal approval processes.

It is under the umbrella of Expanded Access that the non-profit Multidisciplinary Association for Psychedelic Studies (“MAPS”) successfully applied in January for an expanded access program to run alongside its ongoing Phase 3 clinical trials into the use of MDMA to treat post-traumatic stress disorder (“PTSD”).

Allowing access to psychedelic medicine outside of a formal clinical trial, especially in the U.S., was a momentous breakthrough for advocates of psychedelic-assisted psychotherapies, providing further mainstream acceptance of their promise in an area where most existing therapies provide limited benefit.

Not wishing to be left behind by their American counterparts, it now seems the Canadian authorities have entered the race to relax the regulatory environment and allow trailblazing firms the opportunity to evaluate how to best deliver tomorrow’s blockbuster treatments.

The Canadian equivalent to Expanded Access is called the Special Access Program, but it has historically been limited by precluding access to certain substances, including psychedelics. Here, when a new drug is under development, Health Canada has encouraged Compassionate Access trials whereby patients may access treatment in a controlled setting that is positioned to provide outcome and safety data to regulatory authorities. 

Significantly, research projects run through Compassionate Access may be the lowest cost and fastest ways to create legal, for profit psychedelic-assisted psychotherapy models in Canada.

Run by an expert team of researchers in this field, Numinus (TSX-V:NUMIrecognized that a strategy to maximize its long-term position as a leading provider of psychedelic-assisted psychotherapies would be to pursue implementation science research through the implementation of Compassionate Access protocols.

The company was already considerably advanced in developing protocols, so the timing of the Health Canada Section 56 award could not be any better.

With its $4 million funding nearly in place, Numinus (TSX-V:NUMIcan confidently accelerate its plans and secure for itself a market-leading position in what is likely to become a multi-billion dollar industry.

READ OUR SPECIAL REPORT – To discover how Numinus’ (TSX-V:NUMI) expert team is at the forefront of developing healing treatments for the mind

Backed by $4 million, how Numinus (TSX-V:NUMI) plans to become one of the big winners in psychedelic-assisted psychotherapies

The prize on offer for developing effective psychedelic-assisted psychotherapies is colossal.

As many as one in two Canadians suffer from some form of mental health condition by the time they are 40.

Mental illness costs the Canadian economy as much as $51 billion, with as many as 500,000 citizens unable to work due to mental health problems.

These sorts of numbers provide huge incentive to find genuine, long-term solutions to such acute challenges.

Numinus (TSX-V:NUMI) was founded to meet this crisis head on and help solve it.

Developing strategies for the safe and evidence-based real world delivery of  psilocybin and MDMA-assisted psychotherapy through their evaluation in Compassionate Access protocols will provide Numinus (TSX-V:NUMI) with a unique competitive advantage.

The company will be among the first to develop clinical spaces and to collaborate with internationally leading organizations to implement best practices and training standards for the effective delivery of these therapies once they are finally approved for use.

It will develop wider treatment programmes that wrap-around psychedelic-assisted psychotherapies and promote wellness, healing, and long-term recovery. By rolling out these end-to-end care models into a network of wellness centres, Numinus’ (TSX-V:NUMI) goal is to help individuals heal, connect, and grow.

In taking the first-steps in these ground-breaking areas, Numinus (TSX-V:NUMI) will secure its position to become a market leader.

The gauntlet has now been thrown down for the movement of psychedelic-assisted psychotherapies into Canada’s mainstream healthcare system.

When this happens, Numinus (TSX-V:NUMI) will be remembered as one of the firms that opened the door to this revolutionary new wave of treatments.



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In this article:


Author: James Moore

This article does not provide any financial advice and is not a recommendation to deal in any securities or product. Investments may fall in value and an investor may lose some or all of their investment. Past performance is not an indicator of future performance.

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