Daily Archives: June 13, 2020

2020 is the year of many things: global conflict, devastating fires, the COVID-19 pandemic, and now civil unrest in response to racism and police brutality in the United States.

It’s been a tough year for everyone, but it has also brought about renewed conversations on societal progress. How can we improve, where do we go from here, and what changes can we start to make?

Strangely to some, one of those changes is coming in the normalization of psychedelics to treat medical conditions. What was once a stigmatized and prohibited class of substances is quickly having a second wind as a treatment for depression, PTSD, and substance-abuse disorders amongst a handful of many other potential therapeutic needs.

We’re also now starting to deal with a wave of new (and previously undiagnosed) cases of depression and anxiety on the back of the COVID-19 pandemic. One week into June, we’re quickly approaching a point where many people have been at home with limited social interaction (or physical activity) for months on end.

As if on queue, the market for psychedelics companies has started to open up in a big way. More and more companies directly and indirectly invested in psychedelics are coming to public markets, and others are starting to make their moves into psychedelics widely known. 2020 is the year of many things, and it’s looking like psychedelics is one of them.

Back in May, we highlighted the impressive rise of a few of the companies involved in the psychedelics market. Those included the recently-public psychedelics companies Champignon Brands Inc. (CSE:SHRM) and Mind Medicine Inc. (NEO:MMED), as well as indirect investments like those of Yield Growth Corp. (CSE:BOSS) and Revive Therapeutics Ltd. (CSE:RVV).

Fast-forward a few weeks and we’ve seen even more companies enter the fray. On May 20, fully-integrated psychedelics company Numinus Wellness Inc. (TSX-V:NUMI) went public, with business arms in clinic and therapy operation, research and development, and direct selling and distribution of psychedelics. On May 28, Ontario-based Red Light Holland Corp. (CSE:TRIP) also began listing with a plan to produce and sale psilocybin in the legal Netherlands market for the time being.

We’re also seeing an increasing wave of acquisitions and pivots into psychedelics from companies previously invested in healthcare, cannabis, and even technology. German medical cannabis distributor Pharmadrug Inc. (CSE:BUZZ) acquired Dutch psychedelics retailer Super Smart, California cannabis company Hollister Biosciences Inc. (CSE:HOLL) closed their acquisition of mushroom-based health product developer AlphaMind Brands Inc., and eCommerce CBD provider Mota Ventures Corp. (CSE:MOTA) acquired pharmaceutical psilocybin manufacturer Verrian Ontario Ltd.

And that’s not including the previous moves of companies like New Wave Holdings Corp. (CSE:SPOR) in psychedelics and esports, Empower Clinics Inc. (CSE:CBDT) in creating its own psilocybin and psychedelics division, and NewLeaf Brands Inc. recently adding a focus on psychedelics and rebranding as Mydecine Innovations Group Inc. (CSE:MYCO).

No matter where you look, people and companies are getting invested in psychedelics. Though this has been a somewhat comprehensive list, there are too many to include and more are continuing to pile in. With more excitement about psychedelics and their importance on one hand, and more viable investing options entering the markets on the other, the future for these alternative medicines seems bright.

New to investing in Healthcare? Check out Stockhouse tips on How to Invest in Healthcare Stocks and some of our Top Healthcare Stocks.

For more of the latest info on Cannabis, check out the Healthcare Trending News hub on Stockhouse.

FULL DISCLOSURE: Yield Growth Corp. is a client of Stockhouse Publishing

View original post here:

New Psychedelics Stocks and Acquisitions | 2020-06-08 | Investing News - Stockhouse

Some years ago when the first wave of cannabis firms went public, operators were focused on building a narrative behind one common theme: capacity. Specifically, investment bankers and business executives were focused on touting the square footage of their facility, which in layman terms, could be converted into revenue. If an operator has X square feet, it translates into Y plants, and conversely, Z revenue.

Despite touting their own company as the best potential operator in the space, collectively, these investment bankers and executives would collaborate on one topic: the size of the market as a whole, which every year was grown by a few hundred million to entice further investment dollars.

The trouble however, was that these operators were focused on top line revenue potential, and not whether they could actually turn a profit.

Fast forward to the end of the boom and bust cycle, and numerous of these operators are now being sold off for pennies on the dollar, and seemingly have learnt nothing. Few cultivators show promise of generating profits at any point in the future, despite having years to develop proper processes and achieve profitability.

The second wave of operators, referred to commonly as extractors, are in a different category altogether however. Having seen the vast failures exhibited by the first round of contestants, these operators typically focused on a different financial metric: profitability. Having realized the need for certain services within the sector, namely the extraction of cannabinoids for the purpose of oils and cannabis 2.0 products, these operators set out to provide a service that was in high demand within the space and while being able to turn a profit at the same time.

Looking to the burgeoning psychedelics space, and things altogether have not changed much. While the first wave of operators have focused largely on a biotech angle, full of high clinical study costs and potential target markets for proposed cures to ailments, the already oncoming second wave is looking to tackle the space from a different angle.

Presently, that second wave only consists of Pure Extracts (Private), a gray market operator that has entered the legal side of operations. Well known for its years of producing premium quality, full spectrum oil (FSO) Pure Pulls vape pens within the gray market, the operator is now in the process of finalizing its licensing to process cannabis and hemp biomass. Given the strong experience behind it, the Company has already signed two tolling agreements for a total of 120,000 kgs/annum of hemp and cannabis despite not quite having its license yet, although it is believed to be imminent. Despite being significantly impressive, this isnt even the most interesting part of Pure Extracts story.

That is reserved for the Companys step into the psychedelics space. Rather than focus on biotech themselves, the Company has come to the realization that all these studies will require one key ingredient psilocybin extract. As a result, Pure Extracts is submitting its Dealers License application to Health Canada to enable the Company to extract this ingredient for operators in the space that need it to conduct clinical studies. Psilocybin extract, given its relative scarcity, is currently a high value item, and currently fetches upwards of $10,000 per gram.

Outside of research purposes, there is also currently a large demand for functional mushroom extracts think already legal markets for non-psychoactive variants. Here, the functional mushroom market is one of the fastest growing CPG segments. With research showing mushrooms containing properties such as immune boosting, detoxification, anti-tumor, and anti-viral and more the race is currently on for extractors to step into the growing segment. Many extraction competitors are unready for the new psychedelic and functional mushroom markets, whereas Pure Extracts is already moving with precision to tackle the segment head-on. The segment offers massive opportunity for those who elect to grab a first mover advantage.

In this regard, Pure Extracts has laid out a simple business development strategy. Theyve positioned themselves in a manner that enables them to become the premier commercialization and manufacturing partner for both functional and psychedelic firms within the space. While initial products under this operating segment will be focused on functional products, the Company is submitting an application for its Dealers License as previously mentioned, which will enable them to buy, sell, test and product psychedelics within an EU GMP environment.

Here, Canadas ability to export such products around the world, combined with Pure Extracts Good Production Practice (GPP) facility will enable the Company to be a prime partner for both functional and psychedelic mushroom firms. Furthermore, the Company has already set the strategy in motion, having signed several NDAs with functional product firms to explore joint development strategies. These product lines are currently targeting a third quarter 2020 launch.

While new operators seemingly appear each week within the biotech-based psychedelic space, Pure Extracts offers a compelling type of exposure to the niche market that has yet to be addressed. The need for such extracts is apparent given the growth in the sector, however the lack of competition gives Pure Extracts an early edge in what is set to be a high demand segment.

Pure Extracts is set to IPO in the coming months.

FULL DISCLOSURE: Pure Extracts is a client of Canacom Group, the parent company of The Deep Dive. The author has been compensated to cover Pure Extracts on The Deep Dive, with The Deep Dive having full editorial control. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security.

As the founder of The Deep Dive, Jay is focused on all aspects of the firm. This includes operations, as well as acting as the primary writer for The Deep Dives stock analysis. In addition to The Deep Dive, Jay performs freelance writing for a number of firms and has been published on Stockhouse.com and CannaInvestor Magazine among others.

Go here to see the original:

Pure Extracts: The Second Wave of Psychedelic Operators - The Deep Dive

There was a lot of excitement when the FDA fast-tracked ketamine trials for depression treatment in 2016. The announcement marked a major turning point in our understanding of psychedelics, which were deemed a Schedule 1 substance as part of Richard Nixon's racist 1970 "War on Drugs." Ketamine was approved for use as an anesthetic that same year; due to increasing recreational usage in the 1990s, however, it was deemed Schedule III in America in 1999.

Though ketamine is not a traditional psychedelicthey have an agonist (or partial agonist) effect at brain serotonin 5-HT2A receptorsit falls into this class due to its hallucinogenic and dissociative effects. Recently it has been referred to as a "party psychedelic." Psychedelic therapy advocates were pleased when the FDA approved a nasal spray medication for treatment-resistant depression known as esketamine in 2019. Janssen Pharmaceuticals launched Spravato shortly after.

This move is exciting. Trials of two types of ketamineracemic ketamine and esketamineshowed early positive results, even though researchers are not exactly sure how it functions in depression treatment. We do know antidepressants and antipsychotics are showing less efficacy and more chronic side effects than previously believed, however.

There is precedent in the psychedelic realm. Psilocybin, ayahuasca, ibogaine, MDMA, and LSD are showing early positive results in treating anxiety, depression, addiction, and PTSD. This does not mean we should rush blindly ahead, however.

That's the consensus reached by Mark Horowitz (writer) and Joanna Moncrieff (editor), whose recent analysis, published in The British Journal of Psychiatry, concludes that we're moving too fast in clinically adopting ketamine. As their data shows, caution is necessary.

Since its discovery in 1962, ketamine has been used broadly as a sedative and anesthetic; to aid in emergency surgeries in war zones; as a bronchodilator for severe asthmatics; to treat certain type of seizures; in postoperative pain management; and now, as a nasal spray to treat depression. Unlike SSRIs and SNRIs, esketamine works immediatelyin as little as two hoursmaking it more attractive to patients and clinicians.

While treatment-resistant depression sounds extreme, Horowitz notes the definition: patients unsuccessful with two different antidepressants, a low bar for the term "resistant." The problem with trying esketamine, he writes, falls back on the FDA fast-tracking of the drug.

"Out of the three short-term trials conducted by Janssen only one showed a statistically significant difference between esketamine and placebo. These were even shorter than the 68 week trials the FDA usually requires for drug licensing."

Each trial lasted only four weeks. The FDA normally requires that two such trials show better results than the placebo; in this case, only one achieved this goal. The successful trial showed a four-point margin on a scale that goes to 60.

Failing to provide two effective trials, the FDA allowed Janssen to submit a discontinuation trial as evidence. This 16-week trial let patients either continue or stop treatment. The problem: side effects were treated as evidence of relapse, not withdrawal symptoms.

Ketamine users have a long history of withdrawal issues, including anxiety, poor appetite, delusions, hallucinations, paranoia, addiction, rage, and craving. The discontinuation trial considers such effects as proof of ketamine's efficacy, not as symptoms of withdrawal.

Science writer Peter Simons explains why this is worrisome:

"Perhaps even more concerning is the fact that, within the discontinuation trial, a single site in Poland drove the apparent finding of efficacy. Data from this site suggested that 100% of the placebo group supposedly relapsed (compared with about 33% of the placebo group in all the other sites)an unlikely result. When data from this suspicious outlier was removed, the study analysis showed no evidence that esketamine was better than the placebo."

Add to this that six people in the esketamine group died during the trials, including three by suicidetwo of whom had previously shown no signs of suicidal ideationsand a troubling picture emerges. The FDA accepted Janssen's explanation: the problem wasn't esketamine, but their underlying condition. This is possible, but the company did not provide conclusive evidence.

Jennifer Taubert, executive vice president and worldwide chairman of Janssen Pharmaceuticals, Johnson & Johnson, testifies before the Senate Finance Committee on "Drug Pricing in America: A Prescription for Change, Part II" February 26, 2019 in Washington, DC. The committee heard testimony from a panel of pharmaceutical company CEOs on the reasons for rising costs of prescription drugs.

Photo by Win McNamee/Getty Images

According to Horowitz, this is a chronic problem with clinical trials and governing agencies.

"It would seem that themes from history are repeating: a known drug of misuse, associated with significant harm, is increasingly promoted despite scant evidence of efficacy and without adequate longterm safety studies."

He also notes that half of the patients experienced disassociation and one-third experienced dizziness. On this point, allow me to break the fourth wall. I've been experimenting with psychedelics since 1994 and am writing a book on psychedelics in ritual and therapy. I ingested a range of substances during my college years. By far, the most troublesome was ketamine. While I'm now aware of Parecelsus's dictumwhat is beneficial in small doses is toxic in large dosesI wasn't measuring it out in the 1990s.

Administered doses in Janssen's trials were considered similar to recreational usage. I recall that a bump provided an energetic lift, yet when I'd occasionally snort a line, all bets were off. After a hearty dose one evening, I laid down, sat up, and stood in succession. I couldn't tell the difference between those three physical positions. Ketamine is the most dissociative substance I've ever taken, and I stopped shortly after that last instance.

Psychedelics are the next wave of mental health treatmentscall it a continuation, given their role in traditional rituals. We came to rely on pharmacology too much in the twentieth century; hopefully we're learning from those mistakes. As Horowitz points out, however, it appears we're not.

The important word in psychedelic therapy is ritual. There are environmental and social factors entwined with our health. In the right context, psychedelics have tremendous healing power. And to be fair, some ketamine clinics are taking proper right safety precautions as well as designing treatment rooms to be more conducive to healing than sterile white rooms. Patients are anecdotally reporting success in depression treatment with ketamine. This isn't an either-or situation.

But we cannot make the same mistake we've made with CBD and believe these substances are cure-alls. We also can't afford to designate ketamine under the umbrella term "psychedelics." As Alan Watts wrote, hallucinogen is not a proper definition of the psychedelic experience, though it's fitting when describing ketamine. Conflating substances will only further confusion during a time when we need clarity. If the addictive properties and dangerous side effects of ketamine play out widely, it endangers the entire psychedelic therapy model.

We can hope for a clinically-effective dosage and delivery mechanism of ketamine. We can't, as Horowitz's analysis shows, make the same mistakes over. Pharmacological intervention has a place in psychiatry, but it's come to dominate the industry, often no better than placebo and psychotherapy. We need healing, not more side effects.

--

Stay in touch with Derek on Twitter, Facebook and Substack. His next book is "Hero's Dose: The Case For Psychedelics in Ritual and Therapy."

From Your Site Articles

Related Articles Around the Web

Read the original post:

New analysis claims the FDA rushed ketamine's approval for depression treatment - Big Think

As people face their issues, Vasquez is there to call out trauma responses so they know to soothe those reactions and keep working through it. While the cannabis, journaling, and talk therapy work helps soothe and process triggers, the psychedelic element can allow you to go deeper into the cause of that trigger.

"In small amounts, on a controlled schedule, you can process a lot of trauma very quickly with psychedelics," says Vasquez. Even those small amounts can shine a light on dark corners of your memory. You dont always know what you will find in those corners. I just let my clients know that they are safe and that I am here for them on the other side of it. When they come back for our next session, we unpack it together.

One thing Vasquez is clear about is that there is no one perfect dose. And there is often trial and error when first laying down dosing guidelines and a schedule. But thats why the communication and journaling are as important an element as the treatments themselves.

Oftentimes, her clients are on the right track when she meets them. They are on their way to getting to the root of their issues, and what she does can help expedite that process by lifting some of the barriers halting their progress. She explains how unresolved trauma can be a distracting burden in this internal work. How living with trauma is like trying unsuccessfully to sleep soundly every night and going through days half exhausted and half awake.

When you acknowledge what triggers your reactions and the feelings that are rooted in trauma, it can free up space in your life, says Vasquez.

"One of my clients is a medium and a mom, she continues. Mediums already kind of live on two planes, and you have to make a LOT of boundaries with ghosts. It can take a lot of energy. She came to me because she was having problems being fully present in both her day-to-day life and her spirit work.

After six weeks of work with Vasquez, on a regimen that included microdosing mushrooms and CBD with low doses of THC on a controlled schedule, the client reported an enormous difference in her day-to-day clarity. In that case, her client just needed help utilizing her time on both planes more efficiently. And Vasquez helped her do so.

Right now, were all doing more internal work during quarantine. If youre experimenting with different modes of wellness, Vasquez recommending everyone start by journaling every step of the way.

When you're starting any new journey in plant-based medicine, or even a new diet, you must be gentle with yourself, explains Vasquez. Start by microdosing once a month, and listen to your mind and your body as you go. Cannabis and psychedelics can affect your psyche so it is important to note your observations and effects in order to make those judgment calls about dose and schedule.

Vasquez also highly recommends having someone to talk to. As a sort of safety net that helps you process the experience, the talk therapy is as important as the substances themselves. Her favorite part of her work is being that perspective; that ally at her clients side as they work through those triggers.

"Helping others with trauma helps me understand my own trauma, she says. When you live with PTSD, and help people with PTSD, there is just no feeling like it. Its validating. I feel like I have truly stepped into my power.

Originally posted here:

How Liv Vasquez Uses Plants & Food for Wellness and Healing - Thrillist