Category Archives: Psychedelics

OXNARD, Calif.--(BUSINESS WIRE)--CURE Pharmaceutical Holding Corp. (CURE or the Company) (OTC: CURR), a vertically integrated drug delivery and product development company, announced today that it has launched a new initiative for the clinical development of psychedelic compounds such as psilocybin, LSD, and MDMA for the treatment of various mental health disorders.

Utilizing CUREs patented oral film platform CUREfilm for precision dosing, the company intends to optimize the absorption and metabolism of psychedelic actives targeting clinical efficacy of both macrodosing and microdosing treatment regimens. CURE will use its DEA Schedule 1 license and cGMP-certified and FDA-registered facility providing a United States footprint for anticipated commercialization.

Our specialty pharmaceutical pipeline is robust, protected by our IP and differentiated relative to others developing psychedelics, said Rob Davidson, CEO of CURE. Through innovation and selective diversification, we are confident that these new psychedelic programs and our corresponding product development efforts will open many doors to research advancement and new patient solutions. These programs not only broaden our internal pipeline but are also reflective of CUREs focus on treatments for critical disease states including central nervous system disorders, viral infections, and now the serious burden of mental health disorders as well.

Ongoing research, which has been active for decades, continues to showcase a growing body of evidence in support of psychedelics as effective treatments for mental health disorders such as depression, PTSD, addiction disorders, obsessive compulsive disorder, and anxiety. For example, in 2017, the US Food and Drug Administration (FDA) recognized the potential benefits of MDMA by assigning a Breakthrough Therapy Designation to an MDMA-assisted therapy to treat PTSD. In 2019, The Johns Hopkins University launched the Center for Psychedelic and Consciousness Research.

We are dedicated to applying our film technology to leading compounds in high-impact, unmet need areas. Advancing these psychedelic product development programs helps ensure our end-goal of targeting those patients who would have otherwise been left without an important treatment option. We plan to advance our programs in a strategic, thoughtful, and fiscally-responsible way, said Jonathan Berlent, CURE Chief Business Officer.

A recent study published by Data Bridge Market Research states that the legal U.S. psychedelic drug market is projected to grow at 16.3% CAGR from 2020 to 2027 and is expected to reach approximately $6.8 billion by 2027, up from $2 billion in 2019.

About CURE Pharmaceutical Holding Corp.CURE Pharmaceutical is the pioneering developer of CUREform, a patented drug delivery platform that offers a number of unique immediate- and controlled-release drug delivery vehicles designed to improve drug efficacy, safety, and patient experience for a wide range of active ingredients.

As a vertically integrated company, CUREs 25,000 square foot, FDA-registered, NSF and cGMP-certified manufacturing facility enables it to partner with pharmaceutical and wellness companies worldwide for private and white-labeled production. CURE has partnerships in the U.S., China, Mexico, Canada, Israel, and other markets in Europe.

Forward Looking StatementStatements CURE makes in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (Exchange Act), which are usually identified by the use of words such as anticipates, believes, estimates, expects, intends, may, plans, projects, seeks, should, will, and variations of such words or similar expressions. CURE intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and is making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include, without limitation, the ability to successfully market the partnered products, the difficulty in predicting the timing or outcome of related research and development efforts, partnered product characteristics and indications, marketing approvals and launches of other products, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties and the ability to obtain financing on favorable terms. The forward-looking statements in this press release reflect CUREs judgment as of the date of this press release. CURE disclaims any intent or obligation to update these forward-looking statements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of our securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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CURE Pharmaceutical Launches Psychedelic Oral Film Program Targeting the Treatment of Mental Health Disorders - Business Wire

La Jolla, California--(Newsfile Corp. - March 18, 2021) - Tryp Therapeutics (CSE: TRYP), a pharmaceutical company focused on developing clinical-stage compounds for diseases with unmet medical needs, announced today that it has submitted a provisional patent (US 63/161,070) to improve how psychedelics are administered across a broad range of indications.

The provisional patent describes novel methods for the formulation, delivery, and dosing of psychedelics resulting in a potential reduction in the time spent by patients in the dissociative state. These proprietary methods represent the foundational elements of the comprehensive medical treatment program Tryp is developing for a wide variety of conditions. This filing is expected to be the first of a series of patent filings to enhance the effectiveness of psychedelics and to further differentiate Tryp's intellectual property position.

The filing includes a method for measuring the response to psychedelic therapeutics, further supporting a more controlled psychedelic experience. The patent application also covers unique methods to manufacture the active pharmaceutical ingredient, novel formulations, methods to enhance the safety profile of treatments, and methods to reduce risk of abuse and addiction.

"We are seizing the opportunity to further differentiate our intellectual property position in psychedelics through core improvements to the formulating, delivery, and dosing of active ingredients," said Jim Gilligan, Ph.D., President and Chief Science Officer of Tryp Therapeutics. "I am continually impressed with the ingenuity and determination of our world-class team of scientists and advisors. Their innovations are empowering Tryp's work to significantly expand the availability of treatment options for those patients with unmet medical needs by demonstrating the safety and efficacy of our psychedelic drug programs."

About Tryp Therapeutics:

Tryp Therapeutics is a pharmaceutical company focused on developing compounds with known activity and safety profiles for the treatment of rare and other diseases with unmet medical needs. Tryp's psilocybin-for-neuropsychiatric disorders, or PFN, program is focused on the development of synthetic psilocybin as a new class of drug for the treatment of certain neuropsychiatric-based disorders. Tryp's lead PFN drug candidate is TRP-8802 for the treatment of fibromyalgia, a chronic pain syndrome estimated to affect more than 5 million people in the United States. The Company is also preparing to initiate a Phase 2a clinical study for eating disorders in partnership with the Dr. Jennifer Miller at the University of Florida.

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In addition to its PFN Program, Tryp is developing TRP-1001, an oral formulation of razoxane for the treatment of soft tissue sarcoma. Soft tissue sarcomas are a rare and diverse group of tumors that account for about 1% of all cancers in adults and 7% in children. Based on the prevalence of soft tissue sarcomas in the United States, Tryp believes it is a rare disease and that TRP-1001 should qualify for Orphan Drug status.

For inquiries, please contact us at:T: 1-833-811-TRYP (8797)E: investors@tryptherapeutics.comW: http://www.tryptherapeutics.com

Forward-Looking Information

Certain information in this news release, including statements relating to the anticipated closing date of the Placement, constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as "plans", "targets", "expects" or "does not expect", "is expected", "an opportunity exists", "is positioned", "estimates", "intends", "assumes", "anticipates" or "does not anticipate" or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might", "will" or "will be taken", "occur" or "be achieved". In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management's expectations, estimates and projections regarding future events.

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the "Risk Factors" section of Tryp's final prospectus available at http://www.sedar.com. These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/77712

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Tryp Therapeutics Announces Provisional Patent Filing For Improved Administration of Psychedelics - Yahoo Finance

A California lawmaker has introduced legislation that would decriminalize psychedelics in the state, the latest bold step in a movement to end Americas war on drugs.

Scott Wiener, the state senator who authored the bill, hopes that in following the lead of places such as Oakland, Santa Cruz and the District of Columbia all cities which have decriminalized psychedelics California will move one step closer to decriminalizing the use and possession of all drugs, something that Oregon passed by voter initiative in November.

People should not be going to jail for possessing or using drugs, Wiener told the Guardian. Its a health issue, not a criminal issue, and I hope that we get all the way there.

This bill, unveiled on Thursday, would decriminalize possession and personal use of psilocybin, psilocyn, MDMA, LSD, ketamine, DMT, mescaline and ibogaine all drugs that can be used for medical treatment. While the decriminalization would apply for any kind of possession or use, not just medical, the bill makes a point to tout the medical benefits of psychedelics, a strategy familiar to drug policy reform advocates.

Thats how it worked with cannabis, said Anthony Johnson, a longtime advocate and chief petitioner for Oregons Measure 110, the initiative that decriminalized personal possession of small amounts of all illicit drugs. Its definitely a way to help people that need it first and foremost, but also then to educate the public about these substances of how the drug war has been a failed policy and how there is a better approach.

The bill would also expunge criminal records for people convicted of possession or personal use of these substances. It would create a taskforce to recommend which regulatory body would oversee personal and therapeutic use of these substances for mental health treatment.

Wiener did not include peyote as one of the substances because of a shortage of the drug among indigenous practitioners, he said. Peyote is a sacred plant for many indigenous tribes, and at the behest of the native community, the bill will not decriminalize peyote, or mescaline when it is sourced from peyote.

In his advocacy, Johnson found that the biggest opponent of decriminalization have been law enforcement, who cite public safety concerns, and those in the private rehabilitation industry. Wiener hopes that testimony from veterans the bill is sponsored by two groups who help them with PTSD and therapists who support the therapeutic use of psychedelics will break down prejudices about psychedelics users.

Theres a stereotype of whos using psychedelics, but its much broader than that and when you have veterans coming into the Capitol talking about how psychedelics help them with PTSD and help them get their lives back, thats incredibly powerful for legislators, he said.

Juliana Mercer, 38, is one of those veterans. She graduated boot camp one week before September 11. In her 16 years as a Marine, 10 of which she was active duty, she served two tours: one in Iraq and one in Afghanistan.

Most of her time involved civil affairs, working with local communities and learning of the devastation of war first-hand. For four years, she was in the wounded warriors unit, providing support and services to injured Marines and their families.

I lost quite a few friends and just saw a lot of a lot of damage and destruction along the way, said Mercer, who described the experience as leaving her with lingering, unaddressed trauma. I put all of that stuff away and kind of forgot about it for a while, and once I slowed down it was all just sitting there and I didnt know what to do with it.

Mercers first foray into psychedelics was recreational. But her experience gave her a feeling of connectedness that she had not felt for a long time, spurring her to reach out to the Heroic Hearts Project, a group that specializes in ayahuasca therapy with military veterans, about a year and a half ago.

Her first session exceeded anything she had expected, releasing years of grief.

I kept hearing that when you do some of these plant medicines, youll be able to do 10 years worth of work in one session, Mercer said. Just one of my sessions really brought out all of that pain and the grief that I didnt even know was in there and allowed me to just completely release it and expel it, things that I had no idea were there.

With the help of her coach and therapist, Mercer was able to unpack why I was so stuck.

It had nothing to do with not knowing who I was or what direction to go, it had to do with just being bogged down with all of these things, she said.

Lauren Taus, a licensed clinical social worker who facilitates ketamine therapy, is adamant that plant medicine therapy is only a potent tool, not a solution, in mental health work but one that should be decriminalized as soon as possible.

We are in a mental health crisis and Covid-19 has exacerbated what was already a crisis, Taus said. And the causes of trauma are multiplying way faster than the solutions. Current treatment is generally not very effective. Psychedelic medicine has been engaged with globally for eons. This stuff works and we deserve to have access to solutions that will be sustainable.

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California bill would decriminalize psychedelics, paving the way for medical treatment - The Guardian

This column is a collaboration with DoubleBlind, a print magazine and media company at the forefront of the psychedelic movement.

Psychedelic reform isnt exactly President Joe Bidens top priority. But as his administration and the new congress gets underway, advocates are hopeful that the next four years will continue to bring policy changes that chip away at the federal prohibition of psilocybin, MDMA, and other psychedelics.

For several years, psychedelics advocates have been focused on local initiatives. This past election, Oregon legalized psilocybin therapy and decriminalized all drugs, while Washington D.C. decriminalized all plant- and fungi-based psychedelics. Since then, California State Senator Scott Wiener has begun drafting a bill to decriminalize psychedelics on the state level, four Hawaii state senators introduced a psilocybin therapy bill, and Florida State Representative Michael Greico has been working on legislation to legalize psilocybin therapy for people with a diagnosed mental health condition. Meanwhile, grassroots activists in dozens of cities and counties (including Chicago, Philadelphia, Berkeley, and Nashville) are seeking to decriminalize psychedelics either at the ballot box or through city council. These initiatives are mostly modeled after the Decriminalize Nature resolution, which decriminalized all natural psychedelics through city council in Oakland in June 2019.

We can look to the cannabis movement to map the trajectory of psychedelics, says Noah Potter, the author of the New Amsterdam Psychedelic Law blog and co-founder of the advocacy organization New Yorkers for Mental Health Alternatives: You saw a wave of state level legislative changes and decriminalization in the 70s and early 80s, and then California voters passed Prop 215 and it went from there, he says. The psychedelic activists are following the same model. Why are you going to bang your head against the wall federally when you can start by dealing with your own local government?

That said, psychedelic insiders are optimistic that alongside local reform there will be federal movement towards ending prohibition, too. Potter says one thing he could see being done immediately by the new attorney general which is likely to be Merrick Garland would be something akin to the Cole Memo. Issued under the Obama Administration, and then rescinded by Attorney General Jeff Sessions following the election of President Trump, the memo directed state attorneys to not enforce federal cannabis prohibition in states where cannabis was legal in some form. Potter says now that Oregon has become the first state to legalize not just decriminalize medical psilocybin, he could see Bidens attorney general doing something similar for psilocybin.

Potter also makes the case that, now that a state is claiming that psilocybin has medical use, the DEA is obligated to schedule hearings to reconsider whether it should be on the Controlled Substances Act. Granted, he says, the DEA also should have held hearings when the first state claimed cannabis had medical use they never did. But, he says, if a member of the public petitioned the DEA to hold hearings based on Oregons new law, they might be forced to. Biden could also just direct the DEA to hold these hearings, although that doesnt seem likely.

By virtue of the DEAs interpretation of the [Controlled Substances Act], once a state finds theres a medical use for a Schedule I substance, they have to hold a hearing before an administrative law judge and hear witnesses and review evidence, says Potter. As soon as a state found there was a medical use for cannabis, the DEA was obligated to hold an evidentiary hearing. I would make the same argument with psychedelics now that Oregon has legalized psilocybin therapy.

The question for many activists now is really: Will the Biden Administration interfere with state, city, and county-level psychedelic reform? Kevin Matthews, founder of SPORE, the Society for Psychedelic Outreach, Reform, and Education, doesnt think so. Since Denver became the first jurisdiction to decriminalize a psychedelic at the ballot box in 2019, the DEA has stayed out of the county, except for when they arrested one magic mushroom dealer who activists believe was just being reckless by publicizing his grow. The DEA has more important things to address than safe psychedelic use, says Matthews, such as the opioid crisis.

Melissa Lavasani, who proposed Initiative 81, which decriminalized all natural psychedelics in Washington, D.C., agrees. I dont think the feds are going to get in the way of cities and states decriminalizing, she says. Theyre going to want to see what happens in Oregon. Theyre going to let the states do their thing and see how everything pans out. Lavasani, who lives in D.C. and worked for the District of Columbia as a senior budget analyst and budget officer for nearly a decade, says shes been connecting with congressmen on both sides of the aisle to gauge their interest in psychedelic reform since first drafting Initiative 81. At this point, shes spoken to about 10 congressmen in total about what they accomplished in D.C., and theyve all responded with openness and curiosity.

However, Lavasani says its important to remember that the cannabis industry still doesnt even have legitimate banking opportunities, so she thinks federal psychedelic reform will be a very long game. She recently founded the Plant Medicine Coalition, a women-led nonprofit, with the intention of increasing access to psychedelic medicine through local and national advocacy. One of their primary goals is to get the federal government to allocate $100 million to psychedelic research. Theyre first going to see if theres a possibility Biden will put it into his budget, although they think thats unlikely. If that doesnt work, theyll start aggressively speaking to congressmen about passing a bill with the funding.

We think that once there is a body of data that is sponsored by the federal government that proves without a shadow of a doubt that there is a therapeutic application, that these are real medicines, thats when things are really going to change in congress, Lavasani says.

Theres hopes of many other changes, too, in the next four years. President Biden sponsored the Reducing Americans Vulnerability to Ecstasy Act, or RAVE Act, in 2003. That law made it a liability for venues to offer harm reduction services, like onsite drug testing, which drug policy activists widely agree has only made festivals, clubs, and other environments where people use drugs more dangerous. Harm reduction activists hope that Biden may support renewed efforts to revise the law.

Theres also been a wave of ayahuasca churches in recent years applying to the DEA for permission to use ayahuasca religiously. Natalie Ginsberg, Director of Policy & Advocacy at MAPS, says shes eager to see an amendment to the Religious Freedom Restoration Act, which considers how spirituality and religion play a role in psychedelics use and traditional practice, while making sure peyote is protected. Something like this, Lavasani says, could be attached to the bill approving the $100 million allocated for federal psychedelics research.

Ginsberg says, generally speaking, she also has high hopes for the Biden administration, especially because he ran on a platform of criminal justice reform and has already ended Justice Department contracts with privately-owned prisons. She says the vision, ultimately, is really to end the war on drugs altogether.

[Its not] unreasonable to hold as a goal that were moving towards, especially because so many states are starting to revisit their approach to drug criminalization, she adds.

Its impossible to put a timeline on all these efforts, but the movement certainly isnt slowing down. And its important to remember, too, says Lavasani, Potter, Matthews, and others, that when the pandemic ends, well be left with its psychological aftermath. This, they hope, will make therapeutic access to psychedelics feel more prescient for legislators everywhere.

My hope with the Biden administration and other lawmakers is that theyre going to be receptive to having a conversation about psilocybin and other psychedelics, says Matthews. Were facing a global mental health and addiction crisis, and thats only been accentuated by COVID-19 with the lockdowns and business closures and further isolation. We need radical, safe effective solutions to address this emergency before it gets any worse.

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Will the Federal Government Finally Embrace the Psychedelic Revolution? - Rolling Stone

For many years, drugs such as LSD, psilocybin and Dimethyltryptamine (DMT) were viewed only as highly dangerous drugs. However, in recent years they have had a bit of rebrand. Now theyre believed by some to have the power to heal, to reconnect us with nature even resolve political tensions.

Use of these drugs is on the rise. At the start of the pandemic in 2020, the UK Home Office released data showing a 230% rise in confiscations of LSD compared to the previous year. The pandemic itself might be changing drug preferences. Almost half of those using magic mushrooms reported using more during the pandemic according to a recent survey.

The changing view of psychedelics can in part be attributed to the renewed interest in their potential to treat mental health problems such as depression. Between the early 1950s and 1970s, there was a great deal of interest in the use of LSD in the treatment for a wide range of conditions, including alcohol use disorders, schizophrenia, childhood autism and sexual dysfunction.

Despite some promising findings, a lack of scientific rigour and wider political and cultural pressures meant that almost all research ended in America in the late 1960s, although it has continued in Europe.

This work has now started up again to a limited extent. As demonstrated with medicinal cannabis, emphasising the therapeutic potential of a drug can help shift attitudes towards it. In recent years, as research activity has increased, media attention has moved from the risks associated with psychedelics to their potential benefits. This has helped reshape attitudes towards this group of drugs.

The gradual rebrand of psychedelics, from dangerous to therapeutic, has been bolstered by a booming wellbeing industry. An increasing number of people are looking for ways they can extend the mind, body and soul. This has led to a rise in companies selling herbal remedies (as seen with the popularity of turmeric touted as natures-wonder drug) and now even psychedelics.

Before the pandemic, psychedelic tourism was a growing niche of wellbeing. One popular strand was ayahuasca retreats in South America, which attracted thousands of wealthy customers keen to explore their psyche.

Ayahuasca has been used in traditional healing and spiritual practices for generations by South American indigenous populations. The potent brew contains DMT, the active ingredient that produces a powerful psychedelic experience. For a few thousand pounds travellers can engage in this practice and claim these celebrity-endorsed rituals as their own to address their physical, psychological and spiritual maladies.

While some are seeking spiritual awakening, others are using psychedelics to boost brain function.

Microdosing psychedelics, which involves taking small doses of the drug, has also grown in popularity. The aim is to enhance cognitive performance, without the disruption of a full-blown experience. People who engage in the practice claim it makes them more productive, creative and focused. The practice has been enthusiastically reported and promoted in media, despite little evidence of its effectiveness.

This has also helped reshape the image of psychedelics, with a focus on benefits including savings to healthcare services rather than the risk of harm. Access to psychedelics has never been easier via the internet and dark web markets.

Likewise, the recent decision by legislators in the US to reduce penalties for possession of small quantities of magic mushrooms reflects the view that these substances are potentially therapeutic, distinct from many other controlled drugs that are discussed in relation to the harms that they can potentially cause.

Private industry, sensing a shift in attitudes and seeing there are profits to be made from legal cannabis in the US, are now setting their sights on psychedelics.

New companies have started up, supported by experienced investors and tech billionaires and advised by leading psychedelic researchers. The initial focus has been on patenting new techniques for synthesising psychedelic drugs and establishing private medical clinics and therapies to distinguish medical uses from recreational.

But as with cannabis, over the long term, as attitudes continue to shift, big money is also likely to be made in non-medical and wellness markets.

While were unlikely to see psilocybin hummus on our shelves, wellness is a trillion-dollar global industry. Whether thats home microdosing kits, spiritual retreats, or therapies for people feeling lost and without direction, where theres a disposable income, theres a psychedelics company with an answer.

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From trippy drugs to therapeutic aids how psychedelics got their groove back - The Conversation UK

In January, an Airdrie man with terminal cancer received the first federally approved magic mushroom treatment in Alberta. This week, the first clinic in the province to use psychedelic therapy has opened in Calgary.

The ATMA Urban Journey Clinic is in northwest Calgary and will be a training centre for mental health professionals from across Canada.

CEO David Harder says the clinic is the result of decades of research and trial studies.

"It's kind of the opposite of what a typical antidepressant or psychotic medication would do," he told The Homestretch.

"Typically, they will suppress or numb down what's happening in your emotions and spirit body, whereas the psychedelics will actually raise those things and allow a therapist to work with you to really work through and not just suppress whatever that is that's holding you back, for example, for depression or anxiety, PTSD especially."

For Tony White, the magic mushroom therapy allowed him to let go of some of the anxiety and depression that had been crowding in since his terminal cancer diagnosis. He received the therapy on Jan. 1.

"I just was lying there and I felt like I couldn't be at more peace then, right then and there," said White in mid-January.

Psilocybin, the active drug in magic mushrooms, has shown promise in relieving end-of-life distress for palliative cancer patients, but it's still undergoing clinical trials.

Since August 2020, Health Canada has granted 20 exemptions to patients diagnosed with cancer to treat their end-of-life distress.

Currently, Health Canada grants exemptions that allow for individual therapy sessions using psilocybin for the terminally ill. The new clinic will start with this mandate, but Harder hopes to see it expand.

"We're also applying on behalf of a number of people with mental health conditions, depression, anxiety and PTSD. So we're going to see if they approve those who are waiting to hear. They seem very open to the idea, but obviously they're being very cautious and moving slowly for safety's sake."

The clinic will administer only magic mushroom therapy for now, partly for safety reasons.

Harder explainedit's difficult to find other psychedelic drugs in a pure state as they are often laced with fentanyl and cutting agents.

"That's why we're only sourcing mushrooms at this point," hesaid. "It's a mushroom. So you can see it. It's a dried mushroom. So that's where Health Canada is saying it's a much less risk than, say, some of the white powder drugs that are being used for psychedelics."

Palliative care therapy is being offered at no cost.

"We believe it's something we can give back," Harder said. "We're moving forward with mental health treatments that will be charged for the treatment of therapy, the therapist's time and on the sitting time. But with the palliative care, we believe this is something where we can give back."

Harder said there is a screening process as part of the exemption application. He said each case may vary but generally the participant undergoes counselling sessions before and afterward. And, he said, there are a couple of people on hand during the four- to five-hour psychedelic experience, including a therapist, psychologist or psychiatrist.

The psychedelic therapy will be overseen by the clinic's chief medical officer, psychiatrist Dr. Ravinder Bains.

Harder said this form of therapy, once more widely accepted, holds promise for a wider range of treatments.

"The studies have been done," he said. "We know this is safe. We know this is efficacious. We know it helps. And with the growing mental health crisis in our country, we know that this is something that could really help the issues that our society is facing."

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Psychedelic drug therapy now offered at Calgary clinic, the first of its kind in Alberta - CBC.ca

SAN DIEGO (KUSI) The Psychedelics and Health Research Initiative at UC San Diego received a $1.3 million grant from the Steven & Alexandra Cohen Foundation to fund a clinical trial investigating the therapeutic potential of psilocybin in treating phantom limb pain, it was announced today.

Psilocybin is a naturally occurring psychedelic compound produced by many species of fungus, including so-called magic mushrooms. Phantom limb pain is pain originating from parts of the body no longer present, such as an amputated arm or leg. It is a form of neuropathic pain that actually originates in the spinal cord and brain.

The grant will fund the first randomized, placebo-controlled human clinical trial examining the safety and efficacy of psilocybin in patients suffering from chronic phantom limb pain. The trial is also designed to explore the brain mechanisms involved, including possible alterations in brain circuitry.

The trial is part of the PHRI, whose mission is to study the potential of psilocybin and related compounds in treating pain and promoting healing.

The therapeutic potential of psilocybin is unique among pharmaceutical agents that are used as analgesics, said Dr. Timothy Furnish, a clinical professor of anesthesiology at UCSD School of Medicine and a co-principal investigator in the trial.

Most analgesic drugs are taken at least daily to treat the symptoms of chronic pain, but they do nothing to change the underlying pathology, he said. Psilocybin has the potential to reset altered cortical brain circuits associated with certain chronic pain conditions. This reset could result in a drug that works on an extended basis (days or weeks) or perhaps even constitutes a cure.

Research at UCSD on psychedelics began in the 1970s with the work of Mark Geyer, a professor of psychiatry and neurosciences emeritus and co-founder of the PHRI. Geyer conducted basic research on the behavioral and neurobiological effects of psychedelics at UCSD.

The PHRI has a briefer history, originating in 2016 with Albert Yu-Min Lin, a research scientist at the Jacobs School of Engineering and Qualcomm Institute, who lost his lower right leg in an off-road vehicle accident. During recovery and rehabilitation, Lin experienced serious, recurrent phantom limb pain.

The pain wasnt subtle, Lin said. It was like being in the heart of a trauma all of the time. It was all consuming, but coming from a part of the body that literally no longer existed. I was desperate. I felt like I was gasping for air in a pool, looking for relief.

During recovery, Lin discovered the work of V.S. Ramachandran, a professor of psychology and neurosciences at UCSD, who had pioneered development of a therapy for treating phantom limb pain. The treatment involves using mirrors to create a reflective illusion of the limb, tricking the brain into thinking movement has occurred without pain or to create positive visual feedback of limb movement. For Lin, the therapy provided pain relief, but only while the mirror was in place.

As a field researcher and explorer for the National Geographic Society, Lin had traveled the world helping develop technologies to assist in archeological digs and similar activities. He was aware that other cultures used plant-based preparations to produce mind-altering, therapeutic effects.

Lin procured some psilocybin, drove out to the desert, boiled it to create a tea and hooked up his leg mirror. He studied the illusion, removed the mirror, studied where his leg once had been and repeated the sequence, again and again.

Within 45 minutes, he said, there was relief.

The pain was gone. I did handstands. It was a profoundly spiritual moment, Lin said. My mind had a map of my body and it was experiencing severe feedback issues, but it had to let go of that map through a sort of state of ego death in which the psilocybin allowed the mind to reject the old map and create a new one. Now, I occasionally have a jolt of pain, but its mostly gone.

But Lin also recognized that his experience was anecdotal and singular, and that more work was needed to help others in similar pain and circumstances. In 2018, Lin, Furnish, Ramachandran and others published a paper in Neurocase describing their collaboration, and in 2019, another account was published in the journal Regional Anesthesia & Pain Medicine.

The World Health Organization estimates that there are more than 40 million amputees in the world, with up to 80% experiencing phantom limb pain. Military veterans exhibit the highest rates of amputation and chronic phantom limb pain, according to previous studies.

Thirty amputees suffering from phantom pain will be enrolled in the three-year clinical trial. Half of the participants will receive 25 milligrams of psilocybin on two occasions; the other half will receive two doses of niacin.

Niacin was chosen as the placebo because it mimics some of the physical sensations that subjects may experience after taking psilocybin, but does not produce a trip, according to Furnish. The trial will include multiple clinical visits to assess pain and psychological functioning, including magnetic resonance imaging.

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UCSD researchers get $1.3 million grant to study psychedelics on phantom pain - - KUSI

NEW YORK, Feb. 16, 2021 /PRNewswire/ --Psychedelics have made some spectacular breakthroughs to gain legitimacy as mental healthcare products and to become an emerging health and wellness market of its own. As these products enter the regulated consumer market, however, it's important that they are reliably and accurately dosed to ensure user health and safety. Accurate dosing is difficult to achieve with botanicals, which is why forward-thinking psychedelics companies are developing new extracted products designed for the most accurate dosing possible. These innovative products include oral tablets, capsules, nasal gels, and more. Forward thinking companies like Pure Extracts (CSE: PULL) (OTCPK: PRXTF), Compass Pathways (NASDAQ: CMPS), Cybin Inc (NEO: CYBN) (OTCPK: CLXPF), AIkido Pharma Inc (NASDAQ: AIKI), and Numinus Wellness (TSXV: NUMI) (OTCPK: LKYSF) are advancing psychedelic medicine with research and development into the best ways to administer these revolutionary treatments.

Pure Extracts Developing State-of-the-Art Psychedelics Extracts

Pure Extracts (CSE:PULL) (OTC:PRXTF)is a Canadian company specializing in functional mushrooms and psychedelics with extensive extraction and production experience. The Company utilizes cutting-edge, sub and super-critical CO and ethanol extraction technology to produce high-quality, high purity formulations on a commercial scale. As psychedelic health and wellness continues its development, Pure Extracts is set up to deliver solvent-free, white-label formulations to service contract sales.

Pure Extracts conducts its extraction at its state-of-the-art facility in Pemberton, British Columbia, located 30 kms north of famed Whistler Resort. The facility is built to EU-GMP specifications, allowing for certification so that the Company will be able to sell its products internationally. On December 16, Pure Extracts announced that the Company had begun to build-out the fourth unit in its facility. This unit is specifically designed for extraction of mushrooms and for research and development of psilocybin. Pure Extracts is currently preparing its application for a Health Canada Dealer's Licence under the Controlled Drugs and Substances Act, which will allow the company to produce, distribute, and sell psilocybin products.

On December 30, Pure Extracts announced the commencement of a new study on the formulation and manufacturing of psilocybin-based active treatments for oral tablets, capsules, and a nasal gel. Conducted at the Toronto Institute of Pharmaceutical Technology by Dr. Alexander MacGregor, the study will focus on formulating, manufacturing, and clinical bioavailability testing of rapid onset psilocybin dosage forms that could be used in future efficacy clinical trials by both Pure Extracts and its pharmaceutical customers.

"We are excited about the R&D progress we are going to make with TIPT over the next six to eight months while waiting to receive our Dealer's License from Health Canada," Pure Extracts CEO Ben Nikolaevsky said in the Company's release. "We will be well prepared for our move into the controlled substances world of psychedelics and will have advanced knowledge regarding psilocybin and its associated novel delivery mechanisms."

Biotech Space Develops Extracted Psychedelic Therapeutics

Compass Pathways (NASDAQ:CMPS)sent shockwaves through the psychedelics space last year when it became the first psychedelics company to list on a major US exchange with its listing on the NASDAQ. The company has continued its research and development into psychedelics, announcing on February 9 the expansion of its Discovery Center and research collaborations with three of the world's most eminent scientists in psychedelic research.

In the fight towards therapeutic breakthroughs for mental health disorders, Cybin Inc (NEO:CYBN) (OTC:CLXPF) has entered into a partnership with Kernel to utilize its Kernel Flow technology to quantify brain activity during psychedelic experiences. Cybin believes that this clinical work could help to fill in the gaps for targeting neurological disorders.

Diversified biotechnology company AIkido Pharma Inc (NASDAQ:AIKI) announced in January that the company had executed a patent license agreement for technology related to psilocybin for cancer treatment and treatment of cancer side-effects. AIkido has been focused on small-molecule anti-cancer therapeutics for decades and the company's CEO says that they believe psychedelics to be an expanding area of treatment.

On February 8, psychedelic-focused mental health and wellness company Numinus Wellness (TSXV:NUMI) (OTCPK:LKYSF) completed its acquisition of Montreal-based full-service well-being organization Mindspace Psychology Services Inc. The company describes Mindspace as "a leader and pioneer in psychedelic programming."

Psychedelics could be the future of health and wellness, and extracted products like those developed by Pure Extracts could be key to unlocking the safe and reliable therapeutic benefits of these products.

To learn more about Pure Extracts, please click here.

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Psilocybin Extracts Could Be the Key to Unlocking Psychedelic Health and Wellness - PRNewswire

Psychedelics are going mainstream.Not only is the US FDA supportive of research, dozens of medical studies are proving such treatments could be helpful, including Johns Hopkins Medicine and New York University. In research to date, psilocybin has been found tohelp treat mental health issues, such as depression, anxiety, obsessive-compulsive disorder, and PTSD. LSD may be able to help patients with alcohol addiction and other mental disorders.MDMA-assisted therapy could help treat eating disorders, including anorexia and binge eating.

In addition, according to Kevin Matthews, founder of The Society for Psychedelic Outreach, Reform, and Education (SPORE), as quoted by Rolling Stone, My hopewith the Biden administration and other lawmakers is that theyre going to be receptive to having a conversation about psilocybin and other psychedelics, says Matthews. Were facing a global mental health and addiction crisis, and thats only been accentuated by COVID-19 with the lockdowns and business closures and further isolation. We need radical, safe effective solutions to address this emergency before it gets any worse.

Thats substantial news for companies such asCybin Inc.(NEO:CYBN)(OTC:CLXPF),Mind Medicine Inc.(OTC:MMEDF),Compass Pathways(NASDAQ:CMPS), andMind Cure Health Inc.(CSE:MCUR)(OTC:MCURF).

Also, take a look at Numinus Wellness Inc. (TSXV:NUMI)(OTC:LKYSF)

Numinus Wellness Inc.just announced that the single-arm, open-label, compassionate access1trial for MDMA-assisted therapy has made significant progress towards treating patients with posttraumatic stress disorder (PTSD). This trial is being pursued in collaboration with MAPSPublic Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of theMultidisciplinary Association for Psychedelic Studies (MAPS), the leading developer of the treatment protocols, research and MDMA-assisted therapy training programs.

We are excited to share an update on the progress of our MDMA compassionate access trial with the full recognition that existing therapies for PTSD are inadequate, said Payton Nyquvest, CEO of Numinus. At Numinus, we are pleased to help foster a promising regulatory landscape that will contribute to a better understanding that psychedelic-assisted psychotherapies are a viable, safe, and necessary avenue for expanding existing treatment options. We look forward to continued collaboration with MAPS PBC and will work together to provide those experiencing PTSD with more treatment options.

This first-of-its-kind trial in Canadahas advanced and successfully transitioned into the pre-implementation stage at Numinus Vancouver clinic. This follows the successful completion of several milestones, starting with the recruitment oftherapists, physicians, and staffin preparation for participant enrolment and the ultimate analysis of therapy outcomes. The highly qualified cohort of medical staff will be responsible for collecting safety data for Health Canada to further implement key research that supports individuals living with PTSD who have not benefited from existing treatment options.

In November 2020, eight Numinus therapists graduated from Part B of the MAPS MDMA therapist training program. Through their roles within the trial, they will complete the supervision requirement for certification as fully qualified MDMA therapists.

A draft MDMA-assisted therapy protocol for PTSD has been adapted for the trial, including clear guidance surrounding necessary screening processes, patient health histories, and indications and potential contraindications before accepting participants. Initial regulatory meetings with Health Canada to define the trials implementation science strategy have been completed, and the next steps will include obtaining ethical and Health Canada approvals to allow the recruitment of participants according to COVID-19 public health protocols.

"Developing a skilled workforce is a key challenge for the safe delivery of psychedelic-assisted therapies, so we are pleased to engage with Numinus to train therapists in the MDMA-assisted therapy protocol for PTSD, said Amy Emerson, CEO of MAPS PBC.

Numinus is also pleased to announce that its Medical and Therapeutic Services Director, Dr. Devon Christie, will serve as both the trials Principal Investigator, and as a therapist. Dr. Christie is a family physician with a focus in multidisciplinary pain management, is a certified Relational Somatic Therapist, and is already MAPS-trained in the delivery of the MAPS MDMA-assisted therapy for PTSD.

I am thrilled to be involved in a long-awaited clinical program that will help pave the way towards wider use of MDMA-assisted psychotherapy for those experiencing PTSD, said Dr. Christie. The key milestones announced today are a true testament to our teams commitment to establishing the physical, technical, clinical and human resource infrastructure needed to swiftly move through the trials formal implementation stages and ultimately towards the recruitment of the first participant.

The safety and efficacy of MDMA-assisted psychotherapy is currently under investigation

It has not yet been approved by Health Canada or the FDA, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future Health Canada or FDA approval or availability of MDMA-assisted psychotherapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from projections.

Health Canada recommends compassionate access open-label clinical trials when drug manufacturers anticipate exceptional demand for a drug, to meet the needs of patients not eligible for enrollment in other pivotal trials (Special Access Program for Drugs: Guidance document for industry and practitioners, Published 2020-10-14). This program is not related to the U.S. FDAExpanded Accessprogram, sometimes referred to as compassionate use or theBreakthrough Therapy designation.

Legal Disclaimer / Except for the historical information presented herein, matters discussed in this article contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Winning Media is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. For making specific investment decisions, readers should seek their own advice. Winning Media is only compensated for its services in the form of cash-based compensation. Pursuant to an agreement Winning Media has been paid three thousand five hundred dollars for advertising and marketing services for Numinus Wellness Inc. by a third party. We own ZERO shares of Numinus Wellness Inc. Please click here for full disclaimer.

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Could the Federal Government Help Legalize Psychedelics? - Baystreet.ca

The antidepressant effects of the psychedelic brew known as ayahuasca appear to be related to anti-inflammatory activity, according to new research from scientists in Brazil. Their findings, published in the Journal of Psychopharmacology, provide new insights into the biological mechanisms behind the observed antidepressant effects of the substance.

Ayahuasca, a concoction used for centuries by indigenous Amazon tribes, contains the powerful psychedelic drug dimethyltryptamine (DMT) and monoamine oxidase inhibitors. The brew is typically prepared using leaves from the Psychotria viridis shrub and the bark of the Banisteriopsis caapi vine.

The authors of the new study were interested in examining the effects of alternative treatments such as ayahuasca because of the widespread prevalence of depressive disorders.

Major Depression Disorder (MDD) is one of the most prevalent mood disorders, reaching about 350 million people worldwide. One third of patients with depression do not show a satisfactory response to antidepressants leading to a large proportion of patients developing recurrent MDD with multiple depressive episodes, said study author Nicole Leite Galvo-Coelho, a professor at the Federal University of Rio Grande do Norte.

In the study, the researchers briefed 28 patients with treatment-resistant depression and 45 healthy controls about the physiological and psychological effects associated with ayahuasca. The participants were then randomly assigned to received either a single oral dose of ayahuasca or a placebo substance.

The placebo substance was a brownish liquid that mimicked the look and taste of ayahuasca. In addition, the placebo contained zinc sulphate, which induces nausea a common side effect of ayahuasca.

After consuming their dose, the participants stayed in a comfortable room at a hospital for about six hours, where they listened to curated music playlists.

The researchers collected and analyzed blood samples from the participants immediately before dosing and again two days later. They were particularly interested in two blood inflammatory biomarkers: C-reactive protein and interleukin 6.

Galvo-Coelho and her colleagues observed significant antidepressant effects among patients who received ayahuasca. These improvements in depressive symptoms were associated with reductions in inflammation.

Patients with treatment-resistant depression tended to have higher C-reactive protein levels compared to the control group at baseline. The researchers found that C-reactive protein levels were reduced in both patients and healthy controls 48 hours after consuming ayahuasca, but not after consuming the placebo.

Besides changes in emotions, MDD also induces biological changes. A better comprehension of these biological changes can help in the development of more efficient treatments. For instance, treatment-resistant depression has been associated with mild chronic systemic inflammation. In this study, a single dose of ayahuasca, and not the placebo, reduced both depressive symptoms and systemic inflammation of treatment-resistant depressive patients two days after the treatment, Galvo-Coelho told PsyPost.

The commercial antidepressants when work spend about 15 days to start the first effects on reduction of depressive symptoms. Regarding their anti-inflammatory action there is not a consensus of how they are acting.

Patients and controls showed similar levels of interleukin 6 at baseline and there was no change after treatment.

Although ayahuasca does not lead to compulsive drug-seeking behaviors or induce physiological toxicity, it does induce acute and mild sympathetic activity. Therefore, patients with cardiovascular disease and who have mania or psychosis must not use it, Galvo-Coelho cautioned.

The next step in this field is to test multiple sessions of ayahuasca associated with psychotherapy as treatment for depression. The studies with psychedelics for mental disorders have shown promising results, but we need a bit more understanding to turn them into an accessible treatment.

The study, Changes in inflammatory biomarkers are related to the antidepressant effects of Ayahuasca, was authored by Nicole Leite Galvo-Coelho, Ana Ceclia de Menezes Galvo, Rassa Nbrega de Almeida, Fernanda Palhano-Fontes, Isaac Campos Braga, Bruno Lobo Soares, Joo Paulo Maia-de-Oliveira, Daniel Perkins, Jerome Sarris, and Draulio Barros de Araujo.

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Rapid antidepressant effects of the psychedelic ayahuasca linked to changes in inflammatory biomarkers - PsyPost