psilocybin Archives - Green Market Report

StaffJune 3, 2021
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Silo Wellness Inc. (CSE: SILO) has signed a letter of intent with Canadian-based mushroom company Mushe Inc. to create the first legal functional and psychedelic mushroom retail outlet based in Jamaica. Silo Wellness currently cultivates psilocybin mushrooms, conducts psychedelic wellness retreats, and is testing a proof-of-concept patent-pending nasal spray.

“As a company, we are very bullish about the high-potential functional mushroom category and the psychedelics sector as a whole. We continue to invest in and expand our operations in Jamaica, the only country where the cultivation, extraction, and sale of psilocybin mushrooms is permissible,” said Douglas K. Gordon, Chief Executive Officer of Silo Wellness. “Consumers are increasingly interested in incorporating mushrooms into their wellness routines. Through our propagation operations, psychedelic wellness retreats, and upcoming retail location, it’s our aim to make mushroom-based products, experiences, and education accessible at a time when so many people are struggling with mental health and other issues.”

According to the company statement, Silo Wellness and Mushe Inc. will build out and operate a “smart shop” retail establishment specializing in the sale of functional and psychoactive mushroom products such as tinctures, capsules, topicals, and edibles, as well as boutique literature and accessories. Earlier this year, Silo Wellness announced a multi-year license agreement with the family of legendary musician Bob Marley for the exclusive worldwide rights to brand, market, and sell a distinct product line of functional and psychedelic mushrooms, which will be sold at the store upon launch.

“In Silo Wellness, we’ve found a partner aligned with our mission to educate consumers about the healing powers of psychedelics and make mushroom-based wellness products and experiences more available,” added Jonathan Rakic, COO of Mushe Inc.  “We look forward to introducing Jamaican residents and tourists to the wide-ranging health and wellness benefits of functional and psychedelic mushrooms – one smart shop at a time.”

While most people associate Jamaica with cannabis and Rastafarians, the country is also considered the epicenter of the psychedelic mushroom movement in the Western Hemisphere, where “magic mushrooms” are openly and legally grown and sold, positioning the island nation to directly benefit from wellness tourism as well as sales of psychedelic mushrooms. The global functional mushroom market size was valued at $46.1 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 9.5% from 2021 to 2028, reports Grand View Research.

 

 


Debra BorchardtJanuary 26, 2021
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As the race to own the psilocybin market heats up, MagicMed Industries Inc. (CSE: MGIC reserved)  announced that it has completed the establishment of the psilocybin-derivatives patent portfolio of the Psybrary and the launch of the Candidate Selection program.  The company said that Psybrary is a proprietary physical and knowledgebase collection of novel psychedelic-derivative drug candidates, manufacturing methods, pharmacological data, and patent filings that protect all of the above.

MagicMed’s Chief Scientific Officer, Dr. Peter Facchini said, “Our psilocybin-derivatives portfolio, which also captures dimethyltryptamine (DMT) derivatives, now includes 12 filed patent applications directed to 9 different chemical compound categories covering over 125 million individual molecules.  While we certainly don’t expect to synthesize all of these molecules during the development of new drug candidates, I am pleased to announce that, as of today’s launch of the Candidate Selection program, we have already synthesized more than 100 distinct psilocybin-derivative drug candidates in our state-of-the-art research and development facilities”.

MagicMed’s Intellectual Property Advisor, Dr. Harm Deckers added, “Filing this broad portfolio of patent applications is an important moment for the Company.  Now that these patent applications claiming composition, manufacture, and methods of use are on file with the U.S. Patent and Trademark Office, international patent treaties prevent worldwide the issuance of claims to other parties, should any file patent applications in the future on any of these 125 million molecules”. The mission of MagicMed is to develop the Psybrary to deliver such much needed improved drug candidates to its biotechnology and pharmaceutical partners.

In December MagicMed closed on an upsized and oversubscribed private placement that brought the company roughly approximately $8.1 million. The offering had been upsized from the previously announced $2.5 million following significant investor interest. The Conscious Fund, a leading global early-stage venture fund investing in psychedelic medicine companies, has made a significant contribution to the round. Founding Partner, Henri Sant-Cassia, commented, “We are very proud to be joining President and CEO Dr. Joseph Tucker and his team on this important journey, as MagicMed is one of the few next generation innovators in the space”.

MagicMed intends to file a non-offering prospectus with certain Canadian securities regulatory authorities and apply to list on the CSE. MagicMed has reserved the ticker symbol “MGIC.”


StaffDecember 23, 2020
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Editors Note: This is a guest post.

Binge drinking has a significant negative influence on the lifestyle of a person. When the drinking pattern starts causing trouble in your life, it’s the onset of alcohol use disorder (AUD). As per recent facts, AUD hits 16 million people in the United States. The common signs of addiction can be light, average, or critical, depending on the various traits that appear. Common signs include:

  • Helpless in controlling alcohol consumption.
  • Not able to quit.
  • A desperate desire to drink.

The excessive drinking of alcohol can affect the liver and brain. This is where the role of psychedelics comes into the picture. Psychedelic substances like Psilocybin affect the brain, helping heal many mental and physical disorders, including AUD symptoms. Let’s first understand how CBD and Psilocybin work.

The Mechanism:

CBD is one of the main components present in Cannabis plants, whereas Psilocybin is the component present in magic mushrooms. These naturally occurring plant-based elements have been discussed for a very long time. Both have been used for centuries for recreational purposes. Various states have legalized both substances and permit their usage to treat some specific conditions. 

Consuming CBD  has a positive impression on the body without any psychedelic effects, whereas mild use of Psilocybin can produce positive effects with some mind-altering experiences. 

The endocannabinoid system (ECS) of the body performs an imperative role in controlling mood, thought, appetite, and pain sensation. It controls neurological processes like stroke, seizures, dementia, and alcoholism. The consumption of these substances can support the ECS by combining with the endocannabinoids to enhance their functionality. 

Drinking liquor can produce intoxicating forces on the brain, creating liver and brain damage, whereas consuming either CBD or magic mushrooms can positively impact the brain, like relieving anxiety and depression. 

Below we will discuss how these naturally occurring compounds can help fight AUD and how to use them for the right results.

CBD and AUD

Cannabidiol (CBD) combines with the endocannabinoid receptors present in the brain and body to manage distress and inflammation. According to reports, CBD’s extended usage in the right dosage reduces cravings for cocaine and withdrawal symptoms. It can improve psychological indications and cognitive abilities. Cannabidiol’s antioxidant properties help strengthen the immune system’s efficacy and repair AUD’s destruction like depression and self-destructive thoughts. 

The research also revealed the consequence of cannabidiol on alcohol-impaired liver inflammation. Researchers discovered that the livers of mice injected with CBD before being fed with ethanol were less impaired than those with no CBD. It reduces oxidative stress, controls inflammation, and kills the cells that cause massive scar tissues. Animal studies suggest that CBD can metabolize lipids, which help decrease the alcohol effect on the liver.

As per another journal, CBD reduced the chances of ethanol resumption in addictive mice, which gradually decreased when researchers increased CBD dosage. 

Thus, these studies explain how CBD can play a crucial role in fighting alcoholism and withdrawal symptoms. Patients with AUD can use CBD in different forms.

Ways to use CBD:

 

  1. CBD oil: A person with alcoholism can add CBD oil to their food or drink. One can also consume CBD oil orally by placing a few drops under the tongue.
  2. Edibles: the huge selection of CBD edibles like chocolates, energy bars, gummies, and cannabis-infused drinks are different ways of consuming CBD.
  3. CBD Pills and capsules: These are the perfect way of taking CBD in small doses. After a meal, taking CBD tablets will help slow the release of its effect that lasts for a long time.

Psilocybin and AUD:

 There are different species of magic mushrooms, of which one is Psilocybe Cyanescens. The psilocybin and psilocin compound present in this species makes it highly psychedelic. Psilocybin can play a crucial role in fighting alcoholism. A journal reports that consuming a high-dose of Psilocybin offers magical effects leading to lower alcohol intake and associated anxiety. People who took Psilocybin say that the mystical event produced by it made them feel great. Psilocybin supported them to ease tension, sadness, and bipolar ailments, which are common alcoholism symptoms. People exhibited enhanced appreciation and connectedness to their surroundings post psilocybin intake.

Another article that took a survey of 343 people who consumed Psilocybin to fight alcoholism found that almost 80 percent of them were free from alcoholism. The rest 35 percent of people said their urge to drink alcohol, reduced after taking a higher psilocybin dose. 

Researchers conducted another experiment to study the effect of Psilocybin, wherein they gave a small dose of Psilocybin to ten members addicted to liquor and with mental dysfunction. The result showed that this small dosage of Psilocybin is enough to ignite alcohol addiction’s healing process. The experiment also gathered the following results:

 

  • Participants who took Psilocybin were less inclined towards drinking alcohol.
  • Patients with alcoholism, desired to make healthy changes by creating a positive mindset. The motivation to shift from addictive behaviors begins due to the Psilocybin’s anti-addictive properties that improve a person’s self-belief in managing alcohol misuse.
  • Psilocybin reduced the dysphoric events of distress, fear, and anxiety produced due to alcohol use disorder.

 

Ways to use Psilocybin:

There are many ways of using Psilocybin to enjoy a psychedelic trip while fighting AUD:

  1. Chew and Swallow: In this method, you must thoroughly chew the shrooms to let the juices come out. When your saliva and the mushroom juices mix, it enters your bloodstream to start working.
  2. Brew: Take magic mushrooms in dried form and brew them and drink as a tea. 
  3. Capsules: This is the easiest method of including Psilocybin in your diet. This way of using Psilocybin allows you to know the right dosage. 
  4. Edibles: Like CBD, one can use Psilocybin to make various food and beverages. You can easily add Microdose Shrooms to your recipes like chocolate truffles, pasta, or honey.

Conclusion:

So, the above mentioned are the ways CBD and Psilocybin can effectively fight alcohol use disorder. The regular consumption of alcohol can increase the risk of physical and mental health problems. Starting with these natural herbs can help in reducing the desire to drink regularly. Along with CBD and Psilocybin, it can be beneficial to visit a therapist who can guide you with the right dosage and other therapies.

 


StaffSeptember 10, 2020
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Havn Life Sciences announced that, on August 31, 2020, its wholly-owned subsidiary, HAVN Research Inc., was granted a Section 56 exemption by Health Canada, meaning it now has the ability to possess certain amounts of pure psilocybin for scientific purposes, specifically for the research and development of quality control methods.

Havn Life said it plans to immediately begin work on experiments with the objective of developing a set of methods for the safe, standardized, quality-controlled production of medical compounds extracted from the Psilocybe spp. mushroom.
“We are thrilled to be among the first to receive permission from the Canadian government to begin work with psilocybin”, stated Tim Moore, Co-CEO of Havn Life. “This important milestone will enable Havn to begin working toward creating method-validation and analytical chemistry to standardize methods for quality control and testing of these substances.”
“Having access to compounds is essential in order to further research in the medical field. This is the start of our journey into developing standardized protocols to ensure that as this industry grows, we understand efficient new methodology”, stated Susan Chapelle, Havn Life Co-CEO, noting the advent of new technology and variables in extraction have changed significantly in the last decade.

Havn recently began trading on the Canadian Securities Exchange using the ticker symbol “HAVN”. Havn Life said it is focused on the standardized, quality-controlled extraction of psychoactive compounds from plants and fungi to develop products for use in research. Havn Life is also developing natural healthcare products designed to unlock human potential, containing novel and natural psychoactive compounds. The company has no revenue as of yet.

“Listing on the Canadian Securities Exchange is an important step in Havn Life’s growth within the emerging global psychedelic space,” says Tim Moore, Havn Life Co-CEO. “There is a tremendous opportunity to transform and enhance the healthcare and wellness space with psychedelic medicine, and the time is now to lay the foundations for what is likely to be a significant industry. Our multidisciplinary team is focused on laying the groundwork by developing quality controls and methodology for research and the medical supply chain.”

Moore was the only employee of Havn when the prospectus was published. Havn Research has a staff of seven, comprising seven consultants and no fulltime employees. Havn Research said it has the qualified personnel required to operate its facility and to develop research protocols and formulate drug compounds

Psilocybin Research

According to the company’s prospectus, Havn Research plans to undertake research to develop the research protocols to cover the production of Psilocybe spp. mushrooms in sterile conditions, the extraction and purification of psilocybin, psilocin, baeocystin, and other compounds found in the genus, and quality control and testing necessary for safety and formulation protocols with Psilocybe spp. and/or constituents. Havn Research said it plans to develop a compound library designed to support the science of safe, quality-controlled psychoactive compounds for the formulation to supply researchers with compounds for clinical trials.
Havn Research said it expects that it will take one year to complete the development of research protocols, after which
approximately an additional four months will be required for the protocols to be published. Havn Research’s research is expected to be split into two 17-week phases and one 18-week phase. The company said it plans to build a dedicated lab facility for its research, formulation, extraction, and pilot-scale manufacturing purposes.
The phase 1 lab build-out is anticipated to cost $300,000 and to be completed by the beginning of the third quarter of 2020. Phase 1 will be designed to meet the requirements to operate under the Health Canada section 56 research exemption. The Corporation also plans to complete a phase 2 lab build-out designed to satisfy the requirements necessary for a Dealer’s License, which it aims to complete by the first quarter of 2021. The phase 2 lab build-out is anticipated to cost $500,000. Havn said it expects it will take an additional four months for the protocol to be published.
HAVN Research aims to have natural health products (NHP) ready for the market in early 2021. HAVN Research said it expects to market its proprietary NHP products under the HAVN brand through a direct to consumer market model and through third party point of sale locations of NHP products.

“We are currently working on a variety of projects including product formulation of effective microdosing of novel psychoactive compounds as well as the development of a state-of-the-art mycology lab for extraction,” said Susan Chapelle, Co-CEO of Havn Life.


Debra BorchardtSeptember 1, 2020
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The UK-based mental health company known for its psychedelic treatments, Compass Pathways has filed to go public this week. The company said it plans to list its American depositary shares on the Nasdaq under the ticker “CMPS”. The company reported total net losses of $13.2 million, $19.6 million and $24.8 million, respectively, for the fiscal years ended December 31, 2018 and December 31, 2019 and the six months ended June 30, 2020.

The company has raised $116 million so far. As of June 30, 2020, it had an accumulated deficit of $62.4 million. Its largest shareholder is Atai Life Sciences, which owns 29% of the stock. Other large shareholders include founders George Goldsmith and Ekaterina Malievskaia each with 16.5% of the company. Entities affiliated with Peter Thiel own 7.5%.

Psilocybin Treatments

The company is known for its pioneering the development of a new model of psilocybin therapy, in which psilocybin is administered in conjunction with psychological support. “Our initial focus is on treatment-resistant depression, or TRD, a subset of major depressive disorder, or MDD, comprising patients who are inadequately served by the current treatment paradigm. The company noted in its filing that early signals from academic studies, using formulations of psilocybin not developed by us, have shown that psilocybin therapy may have the potential to improve outcomes for patients suffering with depression, with rapid reductions in depression symptoms and effects lasting up to six months, after administration of a single high dose.” The company noted that the depression market is seen as a $200 billion market.

“We have developed a proprietary, high-purity polymorphic crystalline formulation of psilocybin, COMP360. In 2019, we completed a Phase I clinical trial administering COMP360, along with psychological support, to 89 healthy volunteers, the largest randomized controlled clinical trial with psilocybin therapy to date. In this trial, we observed that COMP360 was generally well-tolerated. We are currently evaluating COMP360 in conjunction with psychological support in a Phase IIb trial and we plan to report data from this trial in late 2021.”

Use Of Proceeds

The company said it will use the proceeds raised to fund clinical trials, therapist training and other activities to support the development of its investigational COMP360 psilocybin therapy through completion of all ongoing trials through the end of Phase II meetings with the FDA. Compass will also fund research and clinical development activities related to its investigational COMP360 psilocybin therapy to support the progression of COMP360 as a therapy for other neuropsychiatric indications and further our mechanistic understanding of psilocybin. In addition, the money will be used to fund general business development activities, including strategic investments.

Phase 2 trials

Compass is currently conducting a randomized controlled Phase IIb clinical trial in 216 patients suffering with TRD, in 20 sites across North America and Europe. This dose-finding trial is investigating the safety and efficacy of COMP360 combined with psychological support, for the treatment of TRD, and aims to determine the optimal dose of COMP360, with three doses (1mg, 10mg, 25mg) being explored. The primary endpoint of this clinical trial is to evaluate the efficacy of COMP360, as assessed by the change in the Montgomery-Åsberg depression rating scale, or MADRS, a widely accepted scale for depression that has been used as a primary endpoint in pivotal trials of other depression treatments. This trial has been designed to capture a statistically significant reduction in MADRS. Compass plans to report data from this trial in late 2021.
“We are using digital technology in this Phase IIb trial, including an online portal to help patients prepare for their psilocybin experience, and a web-based “shared knowledge” interactive platform to complement therapist training. We are also collecting digital phenotyping information through the measurement of human-smartphone interactions. After the trial, these data will be compared with information collected from validated psychiatric scales, such as MADRS, to develop potential digital applications to help anticipate relapse of depression. In the future, we plan to expand our research into additional digital technologies to complement and augment our therapies.”
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Debra BorchardtJuly 7, 2020
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Despite the continuing opportunities for the cannabis industry, many companies have decided that they don’t want to miss out on the emergence of the mushroom industry. The latest entry to the psilocybin race is CannaGlobal Wellness.

This company is a combination of CannaGlobal, Sansero Life Sciences, and Rise Wellness. The new company said it will focus on psilocybin and other natural compounds to promote emotional, mental, and physical wellness. The company believes that its assembled team of cannabis executives will prove to be a winner in the increasingly crowded space for psilocybin, which is still an illegal substance.

The Team

The company listed the following executives for CannaGlobal Wellness: Lorne Gertner, co-founder of Tokyo Smoke, Cannasat Therapeutics (now Cynapsus Therapeutics), and PharmaCan Capital (now The Cronos Group), will serve as Chairman. Leveraging his vast experience and extensive network in the global cannabis and wellness industries, he founded CannaGlobal to pursue the advancement of cannabis and global wellbeing. Steve Sadoff, co-founder of Sansero, will serve as CEO. Mr. Sadoff has 15 years of experience developing, launching, and growing brands and products within highly regulated environments including nutraceuticals, natural health, and cannabis.

Irie Selkirk will continue to lead Rise Wellness, leveraging her extensive experience as a retailer, patient support expert, and as an educator, facilitator, and leader in the cannabis and psychedelics industries. Dr. Darryl Hudson, Ph.D. Molecular Biology and Genetics, will take on the role of Chief Science Officer, bringing with him a deep understanding and unparalleled expertise in the areas of plant molecular biology, neuroscience, and genetics in cannabis and psychedelics.

“This is a major step forward for mental health in Canada and around the world,” said Gertner. “Psilocybin is proven to have real benefits for treating serious conditions that affect millions of people, and we are excited to be on the cutting edge of helping people improve their lives and making the world a better place, which I am passionate about and have spent the majority of my life pursuing.”

CannaGlobal Strategy

CannaGlobal Wellness said it will bring together Sansero’s science team and capabilities in the development of novel formulations and intellectual property in psilocybin-based treatments, Rise Wellness’ delivery of immersive healing experiences, and CannaGlobal’s network of natural wellness pioneers. The synergies created by this merger will enable the company to offer an extensive and scalable menu of wellness solutions in the short term, while also accelerating the development and commercialization of psilocybin-based neurotherapeutics.

“Three hundred million people worldwide suffer from depression, and one out of 13 people have an anxiety disorder,” Sadoff said. “Without effective treatment, these illnesses can be debilitating, and even life-threatening. But current treatments aren’t universally tolerated and always effective. Our formulations have indicated that psilocybin when combined with natural molecules and world-class immersive healing environments, offers a superior alternative to single-molecule drugs that merely suppress symptoms. This merger gives us the infrastructure and network to bring new, game-changing, neurotherapies to market with maximum efficiency.”


StaffJuly 2, 2020
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A Florida based biotechnology company specializing in the clinical development of psychedelics and analogs is the latest to jump into the quickly growing plant-based medicine field. Psilera Bioscience was launched this month by co-founders Drs. Jackie Salm and Chris Witowski who have 20+ years of combined experience in natural product drug discovery, novel formulations, and are distinguished researchers within the cannabis industry.

“Problems relating to mental health are a growing concern, and the hardships created by COVID-19 have only exacerbated issues with depression, anxiety, and substance abuse,” said Dr. Chris Witowski, CEO of Psilera. “Therapeutic innovations have stagnated in these areas while cognitive disorders such as Alzheimer’s disease also lack effective treatment options. We are only scratching the surface of the medical potential for psychedelics and Psilera’s model of compassion-driven science will enable groundbreaking research to provide new therapies for patients in need.”

Psilera joins a slew of other new companies that have launched in the past couple of years as the excitement over psychoactive mushrooms grows. Psilocybin, the psychoactive ingredient found in some mushroom species, is seen as a treatment for drug-resistant depression. Only a few doses are needed for long-term benefits according to the anecdotal evidence. Psilera said it has accelerated research and development efforts and submitted a provisional patent covering new chemical entities and delivery methods relating to psychedelics.

“Psilera was built with the common goal to create mindful medicine with inspirations from nature and a foundation of innovative science,” said Dr. Jackie Salm, CSO of Psilera. “Our goal is to pave the way for a new era in psychedelics research and truly recognize the potential of these compounds as medicines. This requires detailed assessment of structure-activity relationships and novel ways of delivery. We hope to increase awareness and shift the paradigm to a place of knowledge rather than fear.”


Debra BorchardtJuly 2, 2020
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The star of the quickly growing plant-based medicine field is currently the mushroom – specifically, the psilocybin mushroom. It’s being touted as a treatment for drug-resistant depression and addiction. Clinics are being discussed as places to administer doses of psilocybin, but it seems the non-medical use has been brushed under the rug. A new study explores the case for non-medical psilocybin.

The results published by Psychopharmacology (2020) and led by Carbonaro, T.M., Johnson, M.W. & Griffiths, R.R. studied the subjective features of the psilocybin experience that may account for its self-administration by humans. The test was a double-blind comparison of psilocybin and dextromethorphan (DXM).

Study Results

The researchers were determined to figure out why people wanted to take psilocybin for non-medical uses more than they wanted to take DXM. The study consisted of a single, acute oral dose of psilocybin (10, 20, 30 mg/70 kg), DXM (400 mg/70 kg), and placebo were administered under double-blind conditions to 20 healthy participants with histories of hallucinogen use.

According to the researchers, high doses of both drugs produced similar time courses and increases in participant ratings of peak overall drug effect strength. Nine subjective effect domains are proposed to be related to the reinforcing effects of psilocybin: liking, visual effects, positive mood, insight, positive social effects, increased awareness of beauty (both visual and music), awe/amazement, meaningfulness, and mystical experience.

For most ratings, (1) psilocybin and DXM both produced effects significantly greater than placebo; (2) psilocybin showed dose-related increases; 3, DXM was never significantly higher than psilocybin; (4) the two highest psilocybin doses were significantly greater than DXM. These differences were consistent with two measures of desire to take the drug condition again.

Supported By Other Mystical Measurements

The nine subjective effect domains that psilocybin users experience has been supported by other studies. It was validated in an article published in 2015 by Johns Hopkins Researchers. The researchers took a 30-item revised Mystical Experience Questionnaire (MEQ30) that was previously developed within an online survey of mystical-type experiences occasioned by psilocybin-containing mushrooms. The rated experiences occurred on average eight years before completion of the questionnaire. Their work validates the MEQ30 using data from experimental studies with controlled doses of psilocybin.

The article read as follows: Data were pooled and analyzed from five laboratory experiments in which participants (n=184) received a moderate to high oral dose of psilocybin (at least 20 mg/70 kg). Results of confirmatory factor analysis demonstrate the reliability and internal validity of the MEQ30. Structural equation models demonstrate the external and convergent validity of the MEQ30 by showing that latent variable scores on the MEQ30 positively predict persisting change in attitudes, behavior, and well-being attributed to experiences with psilocybin while controlling for the contribution of the participant-rated intensity of drug effects.

These findings support the use of the MEQ30 as an efficient measure of individual mystical experiences. A method to score a “complete mystical experience” that was used in previous versions of the mystical experience questionnaire is validated in the MEQ30, and a stand-alone version of the MEQ30 is provided for use in future research.

Final Thoughts

Like marijuana legalization, the case for medical use will no doubt push forward the argument for decriminalization and legalization. It is far easier to convince lawmakers of a medical case for legislation versus a mystical experience argument. However, the industry would be remiss to dismiss the non-medical use for psilocybin.


Debra BorchardtApril 29, 2020
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Specialty life science company Revive Therapeutics Ltd. (CSE: RVV) has said that it will investigate novel oral dosage forms of psilocybin, such as oral dissolvable thin films or tablets, based on its wholly-owned patent-pending psilocybin formulations and its exclusive licensed drug delivery technology from the Wisconsin Alumni Research Foundation.

“We are expanding our psilocybin-based pharmaceutical portfolio with unique oral dosage and drug delivery forms that will target and have the potential to treat diseases and disorders currently not investigated with psychedelic compounds,” said Michael Frank, Revive’s, Chief Executive Officer. “We are combining our robust intellectual property portfolio in both psychedelic formulations and our drug delivery technology which is unique within the industry, and leveraging our research partnership with the University of Wisconsin-Madison to establish a specialty portfolio of psilocybin-based pharmaceuticals that we can advance to clinical trials and partnerships with other life sciences companies.”

The company said in a statement that through initial evaluations with its research team, it has found there are several unique parallels between the company’s intellectual property portfolio of psilocybin-based formulations and delivery mechanism and the drug delivery technology, which is comprised of tannin-chitosan composites that have been studied with cannabidiol in the past.  Revive said it intends to research both delivery mechanisms in parallel as each provides its own unique qualities such as the potential of rapid onset of action and time-release compositions.

New Interest in Psilocybin

Psilocybin is being viewed as a treatment for several conditions including drug-resistant depression. Studies have been performed to illustrate the efficacy of psilocybin for this specific purpose. One completed study found that psilocybin produced substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer. The study was published in 2016, and wrote that “At 6-month follow-up, these changes were sustained, with about 80% of participants continuing to show clinically significant decreases in depressed mood and anxiety. Participants attributed improvements in attitudes about life/self, mood, relationships, and spirituality to the high-dose experience, with >80% endorsing moderately or greater increased well-being/life satisfaction.”

According to the World Health Organization, almost 350 million people worldwide were affected by depression in 2016. Common antidepressant drugs help maintain the balance of various hormones and chemicals in the brain, which assists in the treatment of depression.

The Center for Disease Control and Prevention (CDC), reported that the percentage of people above the age of 12 years using antidepressants in the U.S. rose to 12.7% in 2011-2014. According to MedGadget, the antidepressant drug market was valued at $13.69 billion in 2018 and is expected to reach $15.88 billion by 2025. The CDC said that in the U.S., antidepressants were the most commonly prescribed drugs in 2013 and from over 16 million long term users, around 70% are female.

Psilocin Acquisition

In March, Revive completed its acquisition of Psilocin Pharma Corp., a specialty psychedelic sciences company focused on the development of Psilocybin-based therapeutics for significant unmet medical needs including rare and orphan indications. Psilocin developed patent-pending formulation and production solutions for the active compound Psilocybin.  The process encompassed with its intellectual property cover methods of production of Psilocybin-based formulations.

In a statement, the company noted that Psilocin has also developed formulations to date which include the Hydroxy Line.  The line will include PSY-0.1 -Capsules- PSY-0.2 -Sublingual Spray- PSY-0.3 -Gel Cap- PSY-0.4/0.5 -Effervescent Tablets-and PSY-0.6 -Breath Strips.  The precisely dosed formulations will work with both natural and synthetically derived Psilocybin which will be targeted for clinical research and subject to U.S. Food and Drug Administration (“FDA”) approval in the treatment of depression, anxiety, bi-polar disorder, bulimia and anorexia nervosa, and a number of other diseases.  Psilocin’s range of products have been engineered to work synergistically with the body’s own natural pathways of absorption while offering a contemporary approach to consumption

Best Delivery Method

Revive believes that the most optimal delivery method to deliver psilocybin will be in the form of both an oral dissolvable tablet and an oral thin film strip, commonly recognized as a ‘Breath Strip’.  The company said that it is preparing its formulation development plans to pursue clinical studies for indications currently not being evaluated with psilocybin.

The company reported that it has key provisional patent applications with the U.S. Patent and Trademark Office that cover methods of production of psilocybin-based formulations, including sublingual sprays, effervescent tablets, hard-shell capsules, sublingual and transmucosal delivery systems (i.e. gum drops, oral strips, dosing pens). In addition to those patent applications, Revive has a patent-pending portfolio that includes Psilocybin extraction and crystallization methodologies.

The delivery technology is a natural, non-toxic, biodegradable, and biocompatible composite that combines a tannin material, which is derived from a plant group having antibacterial, antifungal, antioxidant and wound healing properties, and a chitosan material, which is derived from the crustacean group having blood-clotting and antimicrobial properties. The delivery technology has a rapid onset of action and controlled or sustained release potential capabilities and may allow combining multiple extracts from mushrooms in one formulation.

Revive is also exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza strains including COVID-19.


Debra BorchardtApril 14, 2020
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Biotech holding company Orthogonal Thinker, Inc. said that it has completed filing a provisional application for the Company’s flagship natural product, Psilly. The provisional application is a legal document filed in the United States Patent and Trademark Office (USPTO), that establishes an early filing date. It does not mature into an issued patent unless the applicant files a regular non-provisional patent application within one year.
“Filing this application allows us to move forward with expanding access to an improved version of psilocin that is not yet available on the market,” said Jason Hobson, CEO of Orthogonal. “This provides us further opportunity to strengthen relationships with organizations across the world who are on the forefront of psychedelic research as we continue to seek partners aligned with our mission to provide holistic wellness solutions. We look forward to sharing our cutting-edge technology to further therapeutic and medical innovations in healthcare. ”
Psilly is Othogonal’s proprietary psilocybin product. The company says that Psilly differs from other psilocybin products in development as it consists of a proprietary formula that uses natural, rather than biosynthetic, alkaloids. According to Wikipedia, alkaloids are produced by a large variety of organisms including bacteria, fungi, plants, and animals. Alkaloids possess psychotropic effects like psilocin and stimulant effects like caffeine.  Although alkaloids act on a diversity of metabolic systems in humans and other animals, they almost uniformly evoke a bitter taste.
The company said that some of the more than $5 million in total seed capital that the company recently raised were allocated to pursue the development and intellectual property protection on Psilly. PsillyLife is the Orthogonal’s lifestyle brand and was conceived to promote education and awareness surrounding the benefits of psilocybin to a worldwide audience.
Potential Patient Population
According to the Centers for Disease Control and Prevention (CDC), antidepressant use in the U.S. continues to grow. Nearly eight percent of the U.S. population took antidepressants between 1999–2002. Between 2011–2014, that number increased to almost 13% of the U.S. public. The global antidepressant and anti-anxiety drugs market is estimated to have reached $12.16bn in 2018. In 2018, the SSRIs segment held 26% of the global antidepressant and anti-anxiety drugs market.

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