Lexaria Bioscience Corp. (NASDAQ: LEXX) Receives Two New Canadian Patents Amid Continued Efforts to Safeguard the Applicability of Its DehydraTECH(TM) Technology in Multiple Jurisdictions and Sectors
- Lexaria has continuously taken steps to protect its intellectual property internationally to safeguard the applicability of its patented DehydraTECH(TM) technology across the globe
- The company recently announced that it had received two new Canadian patents, increasing to 37 the number of granted patents in its intellectual property (“IP”) portfolio
- Lexaria has filed tens of patent applications in multiple jurisdictions that are considered to have the highest commercial potential
- The company continues to investigate opportunities that could culminate in expansions of and additions to its intellectual property portfolio and is also filing new patent applications for discoveries that arise from its R&D programs
Lexaria Bioscience (NASDAQ: LEXX) is a global innovator and biotechnology company focused on developing technology that enhances the bioavailability of multiple fat-soluble active molecules and active pharmaceutical ingredients (“APIs”). The company’s flagship technology is the patented DehydraTECH(TM) drug delivery technology, which combines fat-soluble (lipophilic) molecules or APIs with specific fatty acids and carrier compounds, improving properties such as the speed of onset, brain absorption, and bioavailability.
The company has continuously worked on DehydraTECH since 2014, with these efforts expanding the technology’s potential area of impact, both geographically and by sector. For instance, thanks to its extensive research and development (“R&D”), the company has identified viable commercial applications of DehydraTECH across several segments, including, but not limited to, cannabidiol (“CBD”) for hypertension and heart disease, treatments for dementia, hormone treatments, reduced risk non-combusted nicotine, and more (https://cnw.fm/pNIiY).
“Because of the applicability of DehydraTECH to many market sectors across the globe, we have taken the necessary steps to protect that intellectual property internationally,” the company says in its 2022 Form 10-K annual report (https://cnw.fm/4i9BP). Accordingly, Lexaria has filed tens of patent applications in multiple jurisdictions with the highest commercial potential.
Lexaria believes that the successful granting of more of those applications could lead to material increases in shareholder value. The company also holds that its ability to generate meaningful license revenue from its intellectual property may increase should the remaining patent applications become granted patents.
Since 2014, Lexaria’s efforts to protect its intellectual property internationally have been paying off, with the company receiving granted patents in multiple jurisdictions. Recently, the company announced the receipt of two new patents granted by the Canadian Intellectual Property Office (“CIPO”), increasing to 37 the number of granted patents in its intellectual property (“IP”) portfolio (https://cnw.fm/ZGyAL).
More specifically, the company received a new Canadian patent under its Patent Family #3: “Stable Ready-to-drink Beverage Compositions Comprising Lipophilic Active Agents.” Registered as patent #2,984,917 on CIPO’s Canadian Patent Database, the new patent recognizes Lexaria’s innovations in delivering fat-based (lipophilic) active molecules and active drugs suspended in water-based formats.
Lexaria also received Canadian patent #3,111,082 under its Patent Family #14. Titled “Lipophilic Active Agent Infused Tobacco Leaves and/or Tobacco Materials and Methods of Use Thereof,” the patent covers the company’s innovations that infuse tobacco leaves directly with active drugs or active molecules like nicotine with or without cannabinoids for such potential applications as treating nicotine addictions.
The two new patents increase Lexaria’s Canadian patent portfolio to five granted patents, following the staggered receipts of three Canadian patents over a span of less than a year. Last December, the company announced the receipt of the first granted patent in Canada, registered as patent #3,093,414 on CIPO’s database. The patent, which falls in the company’s Patent Family #6, is entitled “Transdermal and/or Dermal Delivery Of Lipophilic Active Agents.” It recognizes and protects Lexaria’s improved compositions and methods for transdermal and dermal delivery of cannabinoids such as tetrahydrocannabinol (“THC”) and CBD (https://cnw.fm/Cw672).
In June, Lexaria announced that it had received two additional Canadian patents. The first patent is under Patent Family #1: “Food and Beverage Compositions Infused with Lipophilic Active Agents and Methods of Use Thereof,” while the second is under Patent Family #8: “Compositions Infused with Nicotine Compounds and Methods of Use Thereof” (https://cnw.fm/8s8ig).
“Our current patent portfolio includes patent family applications or grants pertaining to our method of improving bioavailability and taste, and the use of DehydraTECH as a delivery platform for a wide variety of APIs including, but not limited to, fat-soluble vitamins; anti-viral drugs; phosphodiesterase inhibitors; human hormones; regulated cannabinoids; and nicotine and its analogs,” Lexaria explains in its most recent Form 10-Q quarterly report (https://cnw.fm/gx8Af). “The company has patents issued in the United States, Australia, Europe, India, Mexico, Canada, and Japan.”
Still, the company continues to investigate opportunities that could culminate in expansions of and additions to its intellectual property portfolio. Lexaria is also filing new patent applications for discoveries that arise from its R&D programs.
For more information, visit the company’s website at www.LexariaBioscience.com.
NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX
About CannabisNewsWire
CannabisNewsWire (“CNW”) is a specialized communications platform with a focus on cannabis news and the cannabis sector. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, CNW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, CNW brings its clients unparalleled recognition and brand awareness. CNW is where breaking news, insightful content and actionable information converge.
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Fear, Freedom, and Answering the Call
Fear, Freedom, and Answering the Call
By Bernhard Guenther
Seeking freedom and sovereignty only externally is futile as long as we have not learned to self-govern and self-rule. And this is the hardest part of the work for the resistance of our lower nature, ego, unconsciousness/shadow with layers of suppressed wounds/traumas, programs, conditioning, attachments, and various occult forces acting upon us is strong…very strong. There are distractions and temptations everywhere.
The inner conquest is a battle much harder than the outer battle. Hence, many people avoid it and externalize everything, caught in endless victim/perpetrator/rescuer cycles, fighting shadows on the wall as they kill and hurt each other.
We must have faith and patience, for we are still little children in light of our evolutionary stage during this Time of Transition. We cannot force the process, for the kingdom of heaven cannot be taken by storm. It can only be revealed by clearing and transmuting what is in the way of anchoring the Divine Light.
This process does require conscious inner work with sincere aspiration. Sincerity with self is key and also the hardest to establish, no matter what image we try to portray externally or even to ourselves. An intellectual understanding and pretense only result in spiritual bypassing and more lies to the self.
Be gentle with yourself, but don’t lie to yourself about what is necessary to truly awaken and live in the Divine as a fully spiritualized soul embodied Divine Being. But before we can become spiritualized and bring forth the soul/true self, we need to become individuated and fully integrated internally [which is the purpose of shadow work]. This step cannot be skipped. Trying it only results in spiritual bypassing.
Most people are still in the consensus state of hive mind existence, identified with certain groups, cultures, society, religions, ideologies, political parties, and flags, where most of their desires are also culturally/socially conditioned, or they are compensations due to [unconscious] trauma, insecurity, etc., like children in adult suits, trying to fill a bottomless hole.
Right now, during this phase of the “awakening” – which often implies a ‘shocking/rude’ awakening – millions of people are just starting their journey of individuation for the first time in their lifetimes. They are just barely getting out of the consensus state of the masses and herd consciousness, which is already challenging as it means letting go of old beliefs, what they “thought” they wanted, and attachments to past associations, friends, and even family – and most importantly, who they “thought” they were. It is a rebirth process—the old must die before the new emerges.
Others fall deeper into the abyss of disintegration and won’t come out of this life. We saw it happening over the past three years, and is even more intensifying. There is nothing wrong with this, for all there is are lessons in the bigger picture of the evolution of consciousness. Some need more lifetimes until the soul is ripe enough to embark on the individuation process consciously.
It’s part and the reason for the “splitting of humanity” prophesized by various esoteric traditions [not to be confused with the artificial Divide & Conquer agenda]. It requires the necessary phase of loneliness to establish healthy solitude and an orientation towards the inner life so we stop grasping externally.
Wherever you are on your journey and evolutionary trajectory, know that there is a bigger plan unfolding, which you are part of; it’s the Divine plan, and no human will can override it. The task is to align our little personal will with Divine Will, which is easier said than done due to the aforementioned [inner] resistance.
We still have a long road and adventure ahead of us and work to do. But it is the very reason we came here for and participate in. The only way out is in and through.
The Task Ahead
The Great Work of soul embodiment/individuation and deep psycho-spiritual work to find the truth of your Being to anchor the Divine Force within as a transducer for Divine Will is the most important work and task over the next years before the window closes during this Time of Transition.
Soul Embodiment IS the antidote to the Soul Harvesting Agenda.
Many are called. Few choose to answer the call. Too many are still distracted by the shadows on the wall via externalizing everything and not seeing the deeper and larger lessons in light of the evolution of consciousness. Or they let inertia, excuses, laziness, short attention span, and mindless distractions get in the way of what is most important. Remember, the moment you are born, you live on borrowed time.
There is also much unknown, and it is in the hands of the Divine, for no one can see with the “eye of the Divine.” So we need faith and trust but not blind faith/trust. We need to use and engage the will to engage in the work with a warrior spirit, for there are many forces vectoring us away from Truth and Self.
The future is not yet set in stone, but we are in for a wild ride, which has only just begun. The past three years were just the opening act. Don’t let fear, worry, doom, and gloom overcome you, for that is what draws these forces in, and they want you to indulge in fear.
But don’t underestimate what is at stake, either. We have work to do, for this is a battle over our souls, literally, but rejoice as the spiritual warrior you came here for in service to the Divine.
They Want You To Be Afraid
Whatever happens or whatever you “think” will happen, remember that FEAR is your only enemy, for fear is the matrix frequency that attracts the hostile forces that feed upon it as it weakens your life force and connection to the Divine.
They want you to be afraid. Afraid of war. Fearful of an attack. Afraid of “others.” When you are in fear, you are easily controlled. Behind hate, blind anger, the cry for retaliation, and violence is fear also.
Any fear that you have is rooted in the fear of death, which keeps you from truly living. The matrix entrapment frequency is based on FEAR. It manipulates you unconsciously and keeps you entrapped out of your own “free will.” When you are in fear, you are most vulnerable to occult entities and your strings being pulled by seen and unseen forces.
The matrix forces want to keep you chained to fear: It disconnects you from your divine power, true self, essence, creativity, inner guidance, intuition, and freedom. Fear keeps you looking outside for guidance. Fear is the foundation of authoritarian followers.
Danger can be real, but fear is a choice, most often an unconscious choice linked to our animal nature.
But not only the obvious mainstream media, Big Pharma and government institutions perpetuate the fear to keep people in line. It’s also religious dogma that has been used for thousands of years for social control, telling you to “fear God” with the corrupted idea that God “rewards” and “punishes” – a matrix program in itself.
Many people who started as sincere truth seekers have also become infected with the wetiko fear contagion. They are lost in the doom and gloom, fear projection of the future, trapped in disempowerment and paranoia.
But it’s not easy to become “fearless,” for most of it runs unconsciously. Many people mask it with a tough exterior or addictions and distractions, anything to avoid facing and feeling that empty hole within – merely compensating for deep-rooted fear and insecurity mostly based on unconscious trauma and shadow aspects.
Fear makes people identify with groups, beliefs, and ideologies.
The only place free from any fear is your true Self, your essence, hidden deep within you, beyond the ego personality you think you are with all its conditioned desires and beliefs. It is not attached to “bad” or “good” experiences.
The more you live from essence, your Self-energy, and make the ego personality a clearer instrument/vessel for it, the less you will live in fear, the less any matrix forces have any effect on you, and the more you are aligned with Divine Will as you become His unique instrument, living out your intended soul purpose.
It’s the ONLY place where true freedom, abundance, love, and joy can be experienced, and it will be reflected in your life.
When you have conquered the fear of death, which entails dying to your old [false] self, you have found the true freedom to live. It is symbolized as the “holy grail” or “philosopher’s stone”, the “second birth”, the [inner] alchemical transmutation from lead (ego) to gold (true Self). It is a rebirth process of facing the dark within, for the “cave that you fear to enter holds the treasure you seek,” as Joseph Campbell said.
It’s the aim of the Great Work.
It’s not an overnight process, and no steps can be skipped. It spans over lifetimes, and it is different for each of us. But at one point in an incarnation, the soul is “ripe” enough as the true Self makes its call from the depth of its being and engages in the work consciously, aspiring and surrendering to the Divine.
You signed up for this a long time ago. See it as a magnificent opportunity for a real Awakening. Remember your mission and, most importantly, remember your Self, the eternal “you,” not that outer persona you mistake for the true self.
It’s up to you to answer the call.
“It is impossible to truly love life as long as one fears death.
The more a person lives with gusto and joy, the less he or she fears death.
The more people shrink in fear of death, the more they cling to life,
not because they enjoy life or because they are dynamically related to it, but in order to avoid death.
Such people really do not live at all.
Every aspect of living follows this principle.
If you desire health in fear of sickness, you prevent health.
If you fear the aging process, you prevent eternal youth.
If you fear poverty, you prevent abundance.
If you fear loneliness, you prevent real companionship.
If you fear companionship, you prevent self-containment.
So it goes on and on…”– Eva Pierrakos
What or who are the invaders by Godgevlamste
What or who are the invaders
Cult: The English term originated in the early 17th century, borrowed via the French culte, from Latin cultus (worship). The French word, in turn, derived from the Latin adjective cultus (inhabited, cultivated, worshiped), based on the verb colere (to care, to cultivate). (The word “culture” also derives from the Latin words cultura and cultus; “culture” in general terms refers to the customary beliefs, social forms, and material traits of a religious or social group. (Wikipedia)
Cult: A system of religious veneration and devotion directed towards a particular figure or object: ‘the cult of St Olaf’ (oxforddictionaries.com)
More related info here: http://www.iskcon-truth.com/bhu-mandala/greater-earth-plane.html
His Channel: https://rumble.com/user/Godgevlamste
420 with CNW — Demand for Marijuana Seeds Booms as Legalization Spreads
Demand for cannabis seeds in America is surging. A wave of cannabis reform has left medical marijuana legal in 38 states, and recreational cannabis is now legal in 23 states. Now that thousands of commercial cultivators across the country can legally grow and produce cannabis, demand for seeds in the United States is skyrocketing.
State-level recreational cannabis policies that allow home cultivation have also contributed to the increase in marijuana seed demand. Since cannabis seeds barely contain any THC and have no potential for abuse, the law essentially treats them like any other seed.
In Minnesota, residents were lining up at cannabis stores to buy seeds the same day the state legalized recreational cannabis. Jordan, Minnesota-based shop Strains of the Earth saw a “huge influx” of Minnesotans looking for and buying seeds on Aug. 1, 2023, the day Minnesota legalized adult-use cannabis.
Owner Jim Cramond says he had uncountable social media requests asking if marijuana seeds were available, and the company served a steady stream of customers throughout the day. Cramond predicted that he would need to restock every three months, but demand for cannabis seeds has been so high he has to order new stock every week to keep up.
Hammond began teaching courses on how to grow seeds into healthy, bud-producing cannabis plants in September and soon had hundreds of customers attending his tutorials without any social media promotion.
Millions of Americans now live in a state with legal recreational cannabis, and interest in home cultivation is on the rise. For Americans who pride themselves on self-reliance and want to consume contaminant-free cannabis, home cultivation allows them to grow their own cannabis from seed to bud without any outside aid. Home cultivation is also a much more affordable alternative to buying cannabis flower as legal recreational cannabis tends to be quite expensive.
Additionally, it is the only way states such as Minnesota where legal sales haven’t officially launched can legally possess cannabis. Minnesotans who don’t want to wait until 2025 when regulators are done setting up a retail market can only access recreational legal cannabis through seeds and home cultivation.
Virginia residents are also stuck in a gray area where the state has legalized the possession and use of recreational cannabis but still hasn’t set up a commercial market. Smoke shops and horticulture companies in Virginia are now selling seeds and donating them in some cases to satiate residents’ demand for adult-use cannabis.
This surging demand for marijuana seeds and products bodes well for ancillary entities such as Innovative Industrial Properties Inc. (NYSE: IIPR) since they are also likely to see growing demand for their products as the cannabis industry grows its reach across the country.
About CNW420
CNW420 spotlights the latest developments in the rapidly evolving cannabis industry through the release of two informative articles each business day. Our concise, informative content serves as a gateway for investors interested in the legalized cannabis sector and provides updates on how regulatory developments may impact financial markets. Articles are released each business day at 4:20 a.m. and 4:20 p.m. Eastern – our tribute to the time synonymous with cannabis culture. If marijuana and the burgeoning industry surrounding it are on your radar, CNW420 is for you! Check back daily to stay up-to-date on the latest milestones in the fast -changing world of cannabis.
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New concerns over possible “ingestible extracts” and cannabis lozenges
Health Canada says it has again identified several edible cannabis products it deems as being incorrectly sold as cannabis extracts.
A spokesperson for Health Canada tells StratCann via email that the regulator is working with several cannabis producers to address the issue.
“Health Canada has identified edible cannabis products erroneously being classified and marketed as cannabis extract products. These non-compliant products do not meet the controls in the Cannabis Act and Cannabis Regulations, which serve to mitigate against public health and public safety risks associated with edible cannabis. These controls include, but are not limited to, a maximum limit of 10 mg of THC per container to help reduce the risk of accidental or overconsumption; limits on the use of certain ingredients; and requirements for preventive control plans to reduce the risk of food-borne illness.
“In cases of potential non-compliance, Health Canada’s preference is for regulated parties to voluntarily undertake actions to come into compliance.”
Health Canada notice
Health Canada is working with several licence holders to resolve any non-compliance.”
Earlier this year, Health Canada sent notice to several companies making similar so-called edible or ingestible extracts containing more than 10 mg THC per container that they would need to cease selling and distributing those products. Health Canada also warned the public about consuming these products.
Since that time, several other similar products have also been released on the market that advertise themselves as cannabis extracts rather than edibles, despite being intended for oral ingestion.
Cannabis producers selling these products maintain that these products were not, and are not edibles, but the federal regulator disagreed.
The federal health authority also issued an online document earlier this year providing clarity on the issue of the classification of edible cannabis. The document, in part, notes that a cannabis edible is defined as any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, or any ingredient that may be mixed with food for any purpose.
“The OCS is re-engaging with all its cannabis extracts suppliers to remind them of their ongoing obligation to ensure that product complies with applicable laws, including the Cannabis Act and Regulations.”
OCS Spokesperson
“Licence holders should verify if their cannabis products are classified correctly. Licence holders are encouraged to review the definitions of, and requirements for, cannabis and cannabis products in the Guide on composition requirements for cannabis products and Packaging and labelling guide for cannabis products.”
One cannabis producer selling such products is challenging Health Canada’s ruling in court. Organigram had to stop selling its ingestible extract product and had its application for judicial review approved in August. Organigram and others who have made these products maintain that they are compliant with all applicable regulations. The court case is now pending.
In instances of non-compliance, the same media representative for Health Canada says it takes a gradual approach to encouraging compliance with its regulations, and points out that they do not formally approve products for sale. Instead, they highlight that it is the responsibility of the licence holder to ensure that their cannabis products are compliant with the Cannabis Act and its regulations.
“In cases of potential non-compliance, Health Canada’s preference is for regulated parties to voluntarily undertake actions to come into compliance. As outlined in Health Canada’s Compliance and Enforcement Policy for the Cannabis Act, the Act contains a number of enforcement tools that may be considered in determining the appropriate actions to prevent or address non-compliance based on a review of the situation and all relevant information, including the public health or public safety risk and the compliance history of the individual or corporation.
“These include measures ranging from compliance promotion and awareness, which are intended to educate and prevent non-compliance, up to measures intended to correct non-compliance or address a public health or safety risk, such as the issuance of a warning letter, suspension or cancellation of a federal licence, the issuance of a ministerial order, or the issuance of administrative monetary penalties.”
The Ontario Cannabis Store (OCS), which manages distribution and sales in the province, has recently sent a memo to relevant licence holders reminding them of their responsibility to ensure products they submit to the OCS are compliant with all applicable regulations.
A spokesperson with OCS expands on this, saying the provincial organization will continue to work with its suppliers to ensure all products sold into Ontario’s legal market remain compliant.
“In response to Health Canada’s compliance statement, OCS engaged with its suppliers in March 2023, reminding them of their obligations to comply with applicable law and requesting they identify any affected products. On May 31, 2023, OCS stopped replenishing and accepting deliveries of all products that suppliers identified to OCS as being affected by the compliance statement.
“The OCS is re-engaging with all its cannabis extracts suppliers to remind them of their ongoing obligation to ensure that product complies with applicable laws, including the Cannabis Act and Regulations, and requiring attestation as to whether they have heard from Health Canada about any product(s) that may be affected by the compliance statement.”
420 with CNW — Studies Assert Cannabis’ Safety over Tobacco
Approximately twice as many individuals in the United States perceive that smoking cigarettes poses a more substantial threat to one’s well-being compared to smoking cannabis, and they are correct. Numerous investigations examining the prolonged health consequences of inhaling marijuana smoke dispel the myth that cannabis carries the same well-established detrimental respiratory risks as tobacco.
A case in point is the federally funded study conducted at the University of California where researchers examined the lifetime risk of developing lung cancer among more than 2,000 individuals who were long-term users of marijuana and tobacco or abstained from smoking. The results revealed that those who habitually indulged in tobacco smoking were confronted with a lung cancer risk 20 times higher than nonsmokers, while those who exclusively smoked marijuana showed no increase in their risk.
The lead author of the study expressed that the team’s initial hypothesis of a positive link between marijuana use and lung cancer was entirely refuted as the findings indicated no association and even suggested a potential protective effect.
In a more recent study, a group of healthcare experts contributing to the “Chronic Obstructive Pulmonary Diseases” journal ascertained that past or current cannabis smokers, regardless of cumulative lifetime consumption, did not experience a progression or onset of COPD.
Various other studies assert that the carcinogenic properties of cannabis smoke do not rival those of tobacco and individuals who exclusively use marijuana are exposed to fewer carcinogens and toxicants. Some scientists also propose that the anticancer properties of cannabinoids may mitigate the potential harms associated with inhaling smoke.
Recent research published in the “American Journal of Respiratory and Critical Care” reiterates the distinction, emphasizing that cannabis impacts lung function differently from tobacco. The consequences of widespread cannabis use do not necessarily mirror the harm attributed to tobacco smoking.
A review paper, authored by researchers at the University of Arkansas, unambiguously underscores the contrast, stating that the evidence regarding marijuana stands in stark contrast to the consistent proof of harm from tobacco, the world’s most lethal legal substance. Any conceivable toxicity related to marijuana pales in comparison.
This is not to imply that exposure to cannabis smoke is completely harmless. Marijuana smoke does contain some of the same toxins and particulates found in cigarette smoke. Certain studies have linked cannabis smoking to transient increases in sputum production, wheezing and an elevated bronchitis risk.
Nonetheless, adopting a vaporizer can substantially diminish exposure to combustive toxins. Laboratory research demonstrates that herbal marijuana vaporizers serve as an effective and safer medium for delivering THC, avoiding the inhalation of combustion byproducts. Furthermore, marijuana compounds can be incorporated into a diverse array of products that negate the need for smoking, including edibles and beverages.
The consistent message conveyed by these studies is unmistakable: the disparities in risks between marijuana and tobacco smoke are undeniably significant. This provides additional validation for the belief by enterprises in the cannabis space such as Curaleaf Holdings Inc. (CSE: CURA) (OTCQX: CURLF) that not only has marijuana been unfairly maligned for decades, its supposed risks have also been grossly exaggerated by prohibitionists.
About CNW420
CNW420 spotlights the latest developments in the rapidly evolving cannabis industry through the release of two informative articles each business day. Our concise, informative content serves as a gateway for investors interested in the legalized cannabis sector and provides updates on how regulatory developments may impact financial markets. Articles are released each business day at 4:20 a.m. and 4:20 p.m. Eastern – our tribute to the time synonymous with cannabis culture. If marijuana and the burgeoning industry surrounding it are on your radar, CNW420 is for you! Check back daily to stay up-to-date on the latest milestones in the fast -changing world of cannabis.
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Hearings Commence for Lawsuit Denying Psilocybin Scheduling Change Request
A federal appeals court panel has begun hearing arguments in a case involving a Seattle doctor who sued the U.S. Drug Enforcement Administration for denying his patients access to psilocybin therapy and who is now asking the federal government to reschedule the psychedelic. The suit is part of the Seattle-based doctor’s efforts to expand psilocybin access to terminally ill patients to treat anxiety and end-of-life depression.
Psychedelics such as psilocybin, or magic mushrooms, are all the rage these days thanks to a growing body of research indicating they have potent mental health benefits. Dr. Sunil Aggarwal wanted to use psilocybin, a psychedelic extracted from mushrooms, to help terminal patients at his clinic deal with the anxiety and depression caused by their impending mortality.
The doctor first tried to access the drug for his patients under federal and state right-to-try laws that allow terminally ill patients to use “investigational medications” that still haven’t been approved, but the DEA rejected his request. Aggarwal then sued the DEA, but his lawsuit was ultimately dismissed in early 2022, prompting him to file a formal DEA petition to move psilocybin from Schedule I to Schedule II of the Controlled Substances Act in February 2022.
The DEA rejected the doctor’s petition again and said the U.S. Food and Drug Administration (FDA) had to determine that a substance has an accepted medical use as a prerequisite to rescheduling. In a letter to Aggarwal, the DEA said that the FDA did not outline any accepted medical use for psilocybin and noted that the psychedelic would remain in Schedule I. The ongoing case is Aggarwal’s challenge to the DEA’s latest rejection and will be presided over by Judges Bridget Bade, Daniel Bress and Sandra Ikuta.
While DEA lawyers say their rescheduling petition did not pass the five-part test used to determine if a substance has an accepted medical use, Aggarwal’s lawyers say the test isn’t legal in the first place. According to Matt Zorn, one of the lawyers representing the Seattle-based doctor, the idea that the rescheduling petition doesn’t address the test’s five elements isn’t true.
During oral arguments, Zorn cited a review paper filed alongside the petition that meets all five parts of the test requirements; however, he said the DEA did not evaluate the paper. He also argued that the DEA is using the test to prevent doctors from using treatments that are proven to be safe and effective.
As many more companies such as atai Life Sciences N.V. (NASDAQ: ATAI) publish their research findings in the quest to commercialize psychedelic drugs, regulatory authorities including the FDA and DEA could soon have no choice but to reschedule numerous psychedelic compounds.
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Canalytica Recognized as an Indigenous-Owned Business in Canada’s Official Indigenous Business Directory
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