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Psychedelics company progresses with Health Canada licence

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Psychedelics company progresses with Health Canada licence

Nirvana Life Sciences has announced it is making progress with its Health Canada Dealer’s licence application and its facility development.

Nirvana Life Sciences is researching and developing non-addictive pain management and relapse prevention products. Using naturally sourced psychedelics in novel formulations the company states it will be able to deliver solutions that are effective in managing pain and addiction.

The Canadian applied for a Dealer’s Licence from Health Canada in July 2021 which would permit research and development, manufacturing, import and export, sale to qualified investigators as well as sale to other Licensed Dealers in Canada for 29 different controlled substances.

See also  Health Canada approves low-dose psilocybin mental health clinical trial  

The substances include novel compounds, consisting of different tryptamines, phenethylamines, ergolines and aryl cyclohexylamines. 

Vice president of operations, Michael McCune, commented: “We are pleased with the steady progress that our team is making on licensing. The application for the 29 different controlled substances will support all the projects that Nirvana’s researchers have in the development pipeline.

See also  MDMA, LSD and psychedelic research gets Health Canada exemption

“Our team’s focus on designing to the facility to the highest standard will ensure that our research and development projects meet the rigorous standards of Health Canada.”

As part of its review, Health Canada has requested further detail on volumes of materials to be handled and produced within the facility.

So far, the company has engaged three leading firms to support the projects development. These include CannDelta, a scientific and regulatory consulting company based in Toronto, Ontario; Stratus Designs, a control systems specialist based in BC; and Orion GMP Solutions, a pharmaceutical process engineering specialist based in Rochester, Michigan.

Nirvana has stated its team will develop therapies that have the potential of freeing millions from addiction and saving society billions of dollars annually.

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Small Pharma receives patent grant for DMT injectable formulation

The patent will also protect novel injectable formulations of other known psychedelic compounds.

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Small Pharma receives patent grant for DMT injectable formulation

UK-based Small Pharma has announced that its DMT patent strategy has been strengthened with a new US patent protection on injectable DMT delivery in its lead programmes SPL026 and SPL028.

Small Pharma has received Issue Notification from the United States Patent and Trademark Office that its patent application will be granted on 9 August, 2022 in the US.

The patent is for novel injectable formulations of N, N-dimethyltryptamine (“DMT”) based compounds, and includes novel injectable formulations of other psychedelic compounds, including 5-MeO-DMT and psilocybin.

See also  World’s first DMT-assisted therapy trial successfully completes first phase

Chief Innovation and Intellectual Property Officer of Small Pharma, Peter Rands, said: “Our focus is on developing novel and scalable mental health treatments for patients who are under-served by current medicines. 

“This means diligent assessment of both clinical and commercial potential, and requires a strong patent approach to protect our formulations. We believe that this patent, covering our two most advanced DMT programmes, SPL026 and SPL028, will provide protection of those assets until August 2041. 

“We have focused on protecting our pipeline assets through novel chemistry and, in this case, optimized finished dosage forms.”

The patent represents Small Pharma’s ninth issued patent, and will be the first US patent grant within the company’s psychedelic portfolio, which includes over 70 pending applications, and includes formulations of DMT, the active ingredient in SPL026, and of deuterium-substituted DMT, including the active ingredient in SPL028. 

George Tziras, Chief Executive Officer, added: “This US patent represents a major milestone in our development strategy. It is also timely, as we anticipate dosing completion in our SPL026 Phase IIa trial in patients with Major Depressive Disorder, and prepare for a Phase I study of SPL028 in healthy volunteers in the second half of this year. 

“For Small Pharma’s longer-term vision, the  U.S. will be an important market for DMT-assisted therapies as we look to shape the future of mental health treatments.”

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Psychedelic therapeutics market projected to hit $8.31bn by 2028

A new report suggests the market will grow at CAGR of 13.2 per cent from 2022 to 2028.

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Psychedelic therapeutics market projected to hit $8.31bn by 2028

InsightAce Analytic has projected that the global psychedelic therapeutics market, valued at US$3.61bn in 2021, is expected to reach US$8.31bn (~£6.92bn) by 2028.

With a growing number of people across the globe experiencing poor mental health, not all of which respond to traditional treatments, there is an increasing need for innovative therapies. A growing body of research is now demonstrating that psychedelics could hold promise as treatments for a number of mental health indications.

The new report from InsightAce Analytic suggests that this rise in poor mental health, compounded by the Covid-19 pandemic, along with changed lifestyles and quality of living are fuelling the growth of the psychedelic medicine market.

See also  Advancing psychedelic therapy across Europe

It also highlights that increasing research and development initiatives and the introduction of breakthrough medications that have exhibited efficiency in patients with severe psychological disorders are expected to generate considerable opportunities in the market. 

In 2021, North America dominated the market, and is anticipated to retain its dominance through to 2028 due to the increasing incidence of depression and mental disorders, improved mental health awareness and a rise in research and development efforts. In addition, the increase in mental health-related activity in the healthcare industry to create innovative therapies bolstered regional growth.

As well as including key players in the market, the report explores significant developments that have spurred its growth.

It highlights that, in March 2022, COMPASS Pathways plc entered into a long-term strategic agreement to establish The Centre for Mental Health Research and Innovation to boost psychedelic research and create new mental health treatment modes in the UK. The partnership will speed research into developing psychedelic treatments, promote therapist training and certification, analyse real-world evidence and prototype digital tools to facilitate personalised, predictive and preventative care models.

Other key developments include Mind Medicine announcing the initiation of Project Angie in 2021. The project is aiming to promote the research and development of psychedelics, including LSD, as pain treatments.

Despite positive progression for the market, however, the report also highlights that the wider acceptance of non-therapeutics therapies over allopathic therapies, along with stringent regulations imposed by various governments to commercialise psychedelic medicines, may restrain the market’s growth.

To read the full report please click here.

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Provisional patent filed for psilocybin-based compound

The compound has been designed to treat mental health disorders. 

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Provisional patent filed for psilocybin-based compound

PsiloTec Health Solutions Inc., operating as Zylorion Health, has filed its third provisional patent application with the United States Patent and Trademark Office (USPTO).

Zylorion Health is focused on precision mental health care and psychedelic therapy. The provisional patent application covers the composition of matter of Zylorion’s novel psilocybin-based compound, ZYL-314.

The compound will be used for the treatment of mental health disorders and other central nervous system conditions and cognitive disorders.

See also  Brain activity in depressed people increases following psilocybin use

CEO, Dr Peter Silverstone, commented: “Our clinical team has been working tirelessly with our research partners on the development of novel second generation and industry leading compounds, and we are extremely excited about this discovery.

“ZYL-314 is truly unique and achieving this milestone demonstrates Zylorion’s commitment to bringing innovative new therapies to market and creating long-term shareholder value through a strong portfolio of intellectual property assets.”

The company continues to gather the necessary data and evidence to support the claims and conversion of the composition of matter provisional patent and anticipates filing an application under the PCT (Patent Cooperation Treaty) within the next twelve months.

Zylorion is currently engaged in the development and delivery of integrated precision mental health therapies to address psychological and neurological mental health conditions. 

It is focussing on the research, development and commercialisation of psychedelic-based compounds coupled with novel therapeutic treatment programmes targeting a continuum of mental health conditions, such as major depressive disorder, treatment resistant depression, post-traumatic stress disorder, general depression, anxiety disorders, and a number of addictive tendencies. 

Zylorion has stated that it aims to leverage leading technologies to support the scalability and accessibility of its integrated therapy programmes in its mission to enable those experiencing mental health challenges to thrive.

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Psychedelic Health is a journalist-led news site. Any views expressed by interviewees or commentators do not reflect our own. We do not provide medical advice or promote the personal use of psychedelic compounds. Please seek professional medical advice if you are concerned about any of the issues raised.

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