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Emyria capitalises on Cann Group collaboration to progress EMD-003 CBD medicine for mental health By Proactive Investors

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Emyria capitalizes on Cann Group collaboration to progress EMD-003 CBD medicine for mental health

Emyria Ltd’s (ASX:EMD) is set to capitalize on its partnership with Cann Group Ltd (ASX:CAN) (OTCMKTS:CNGGF) (FRA:CVJ) to complete pivotal clinical trials for its EMD-003 CBD medicine targeting mental health and to seek accelerated registration of a unique, low-dose, CBD-only capsule with the Therapeutic Goods Administration (TGA).

Successful registration as a Schedule 3 medicine would result in an over-the-counter (OTC), pharmacist-only CBD medicine.

The company will lead the EMD-003 drug development program using Cann Group’s proprietary Gelpell microsphere technology to register a unique capsule form.

“Partnership accelerates drug development”

Emyria managing director and CEO Dr Michael Winlo said: “This partnership greatly accelerates Emyria’s EMD-003 drug development program by combining Emyria’s unique clinical data and drug development expertise with Cann Group’s best-in-class CBD delivery technology.

“Cann Group’s CBD has already completed robust stability testing as well as Phase 1 clinical trials as required by the TGA.

“This allows us to move straight to pivotal clinical outcomes trials saving significant time and money.”

Advantages of collaboration

The collaboration capitalizes on a number of registration milestones already met:

  • Real-world clinical data collected with over 400 prescriptions already written for target dose form;
  • pivotal trial protocols developed for target indication;
  • Phase 1 trials already completed for 10mg and 100mg doses of the capsule; other
  • Gelpell has been shown to have 3.5 times the bioavailability of oils (at 100mg) and has large-scale, GMP manufacturing opportunities.

EMD-004 for IBS

Current drug registration programs also include the EMD-004 CBD +/- THC for irritable bowel syndrome (IBS).

The company recently filed a new IP after extensive analysis of its proprietary clinical data collected with consenting patients, who obtained relief from their IBS condition while being treated at Emyria’s wholly-owned, nationwide clinical subsidiary – Emerald Clinics.

There are currently no approved drug treatments for IBS, which affects around 11% of the population globally and is a significant unmet need often associated with greater levels of anxiety and lower quality of life measures.

The company’s patents cover unique dose strengths and formulations, believed to be most effective in treating a range of IBS-related symptoms including:

  • CBD-only formulations, which could support a Schedule 3, OTC registration program in Australia; other
  • CBD and THC containing formulations that could support higher schedule applications and international registrations including US Food and Drug Administration (FDA).

A large observational study involving IBS patients is currently underground across Emerald Clinics.

Psychedelic-assisted therapy program

The company is also progressing its EMDMA-001 MDMA psychedelic-assisted therapy program with partner Mind Medicine Australia, targeting sufferers of treatment-resistant post-traumatic stress disorder (PTSD).

Pending ethics approval, Emyria will sponsor a major, independently monitored, clinical trial targeting treatment-resistant PTSD with evidence-based MDMA-assisted therapy.

A key priority of this first program is to help evaluate the long-term safety, efficacy and cost benefits of MDMA-assisted psychotherapy.

Such evidence is needed, along with fit-for-purpose clinical infrastructure and trained therapists, to deliver psychedelic-assisted care in a safe, standardized and scalable way.

Pending successful ethics review and the finalization of all logistics, EMDMA-001 will begin with a Phase II, open-label clinical trial of MDMA-assisted psychotherapy at Emyria’s fit-for-purpose clinic in Melbourne before expanding to other sites.

Emyria’s pipeline and global registration plans.

Milestones for the year ahead

To progress EMD-003 in the next 12 months, the company plans to:

  • Commence pivotal registration clinical trials – Contingent on a successful ethics committee review in June 2021;
  • Complete trial and commencement analysis – Contingent on recruitment success, which is expected four-eight months after commencement;
  • Prepare product dossier and clinical evidence package to submit to TGA for registration – expected six-eight months after submission;
  • Entry on Australian Register of Therapeutic Goods (ARTG) as a Schedule 3 medication;
  • Finalize commercialization agreements and commence sales as an OTC Schedule 3 medicine; other
  • Commence international registration activities.

In parallel, Emyria will commence psychedelic-assisted therapy trials, registration trials for EMD-004 and launch registration programs for the US FDA and the European Medicines Agency (EMA).

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CBG! A Compound With Intriguing Medical Potential

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Consumers would be forgiven for being skeptical. Unregulated CBD products are sold as cure-alls in strip malls and convenience stores. CBN doesn’t live up to its billing as a standalone sleep aid. Sketchy hemp-derived Delta-8 and Delta-9 THC Consumables are designed explicitly to evade legal restrictions. But some say the next cannabinoid to grab the attention of health-conscious cannabis users may well be worth a closer look: Cannabigerol or CBG.

CBG is often billed as “the mother of all cannabinoids” because its acidic precursor – CBGA – is also the precursor of tetrahydrocannabinol (THC), cannabidiol (CBD), and other cannabinoids present in the cannabis plant. As the plant matures, most of its CBGA is converted to other molecules, leaving very low levels of CBG in the mature, dried flower – typically below 1% by dry weight. Specially bred strains, however, can produce close to 20% CBG (but little THC) – and that could be a boon for the medical cannabis community.

Potent But Nonintoxicating

CBG was first isolated in 19641 and synthesized in 19712 by “Godfather of cannabis research” Raphael Mechoulam and frequent collaborator Yechiel Gaoni. But it spent the next few decades in relative obscurity. More recent preclinical research has shown that this versatile, nonintoxicating compound is a weak partial agonist or activator of the cannabinoid receptors CB1 other CB2an antagonist of the serotonin 1A receptor, and an agonist of the inhibitory neurotransmitter GABA. It’s also a PPARy agonist and the only known cannabinoid to function as an agonist at the alpha-2 adrenergic receptor.3

Today CBG is better understood and more widely used than ever before, with unregulated CBG– Rich products available online.

Despite CBG‘s unique and promising pharmacology – reviewed in a couple of new papers45 – research into its effects in humans has been relatively minimal. As recently as a few years ago, CBG-dominant cannabis varietals were almost unheard of, and any producers that wanted the compound could not easily access it. Today CBG is better understood and more widely used than ever before, with unregulated CBG– Rich products available online. but CBG still maintains a low profile, even in state-licensed dispensaries.

If recent trends and research findings are any indication, however, that may change soon.

CBG in Practice

Medical cannabis expert and physician Dustin Sulak is among CBG‘s believers. He has been treating patients at his two integrative medicine clinics in Maine with CBG-dominant cannabis for about a year. “I’m seeing strong signals of efficacy in anxiety, pain, and sleep disturbance, usually at doses lower than those required when treating similar symptoms with CBD,” Sulak said by email. “Adverse effects are mild and infrequent, with tiredness being the most common.”

Along with his medical practice, Dr. Sulak also runs an educational platform called Healer.com, which sells products – including CBG capsules and oil drops – made from Maine-grown organic hemp. Healer’s website suggests these products offer “calming effects and superior relief from occasional sleeplessness, physical nervousness, ‘flight or fight’ feelings, and … nerve discomfort not addressed by CBD other CBDA.” Also distinguishing it from CBDwhich inhibits THC activity at the CB1 receptors CBG does not diminish the cannabis high.

An article by Sulak on the company’s website outlining the potential benefits of CBG acknowledges that while much of what’s known about cannabigerol is based on cell and animal studies, the compound “[shows] promise for improving conditions including inflammatory bowel disease, other inflammatory conditions, glaucoma, mood disorders, and nerve pain.”

CBG for Pediatric Patients

California-based cannabis physician Bonni Goldstein also occasionally prescribes CBG, including for children suffering from autism-related symptoms like anxiety, hyperactivity, digestive issues, and speech problems. Typically CBG is added to an existing regimen of CBD other THCshe says, starting at very low doses and titrating up until an effect is observed.

dr Goldstein, author of Cannabis Is Medicine, suspects that many of the positive outcomes she’s observed are related to CBG‘s ability to reduce inflammation. In any case, some guesswork is involved given the paucity of available data on the compound’s effects in humans (particularly children) and the wide variability of effects typical of all cannabinoids. She also acknowledges that not all patients see benefits.

CBG is under-studied, but I can report to you these findings,” she says. “I have seen CBG cause increased [problematic] behaviors in some children with autism, but the minute we see that then we just don’t use it anymore. I’ve also seen that in some of the patients it can be chemovar-dependent. At this point, it’s still trial-and-error for most families.”

In adults, Goldstein has seen CBG help treat anxiety and pain, including in individuals for whom CBD wasn’t effective or only worked at too high a dose to be affordable.

survey data

Sulak’s and Goldstein’s clinical experiences with CBG appear to be reflected in the findings of a survey of 127 CBG users described in the October 2022 issue of the journal Cannabis and Cannabinoid Research.6 Performed by medical cannabis expert Ethan Russo of CReDO Science together with researchers at Washington State University and the University of California in late 2020, it’s the first patient survey of CBG-predominant cannabis use to date.

Responders reported efficacy for anxiety, chronic pain, depression, and insomnia – often surpassing that of conventional medications – without significant side effects or withdrawal symptoms. “People were using it for a wide variety of conditions and almost uniformly found it helpful,” says Dr. Russo, who served as lead author.

CBG users reported efficacy for anxiety, chronic pain, depression, and insomnia – often surpassing that of conventional medications – without significant side effects.

It’s worth remembering that this is a survey, not a trial, and the researchers were not able to control or verify what patients were actually taking. They did determine that CBG had to represent at least 50% of the total cannabinoid content, but some responders indicated that they were also using CBD, THCand CBN in smaller quantities.

Russo says a follow-up study is underway to investigate CBG in humans with a higher degree of confidence, but he already predicts that given its apparent efficacy, safety profile, and lower dosage requirements, the compound is poised to break through to the mainstream – hopefully while avoiding some of the hype and commodification (and attendant quality control issues) of the CBD crazy

“I have felt for a very long time that CBG was an up-and-comer and wasn’t getting the attention it deserved,” Russo says. “We’ve seen a revolution in cannabis therapeutics related to cannabidiol the last ten years, and I think that the same level of excitement is warranted by cannabigerol.”

Nate Seltenrich, an independent science journalist based in the San Francisco Bay Area, covers a wide range of subjects including environmental health, neuroscience, and pharmacology. Copyright, Project CBD. May not be reprinted without permission.

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CBN Gummies for Sleep Washington City Paper

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If you ever have issues falling asleep, rest assured you’re far from the only one suffering from sleepless nights. In fact, nearly 70 million people in the US deal with sleep issues at some point, with up to 30% of adults experiencing short-term insomnia.

While some people find comfort in hot tea before bed, melatonin, sleep medication, the relaxing sounds of beach waves, or breathing exercises, this might not always be the answer. While it’s always best to consult with a medical professional about your options, you might want to consider CBN.

Cannabinol, more commonly known as CBN, is a compound found in the cannabis plant. It’s usually found in higher amounts in aged THC, but can also be produced synthetically and used along with other cannabinoids.

Just like its chemical cousin CBD, CBN isn’t psychoactive. This means you won’t get a “high” off of it, but there are many other reasons people try it out to make the most of its potential benefits (including a full night’s sleep).

We’ve rounded up a list of our favorite CBN products targeted toward sleep, so keep reading to learn more about this cannabinoid and find peace during long nights of tossing and turning.

Key takeaways

  • While more research is needed to determine the benefits of CBN, many people use it to fight insomnia.
  • CBN isn’t psychoactive or mind-altering.
  • We’ve outlined tips to help you pick the right CBN product.

A Quick Look at the Best CBN Gummies for Sleep

Best CBN Gummies for Sleep

FOCL: Best CBD Gummies for Sleep & Editors Pick

FOCL Full Spectrum CBD + CBN Sleep Gummies are our prized editor’s pick, and it’s easy to see why. These melt-in-you-mouth chews are packed with 25mg of premium CBD and 15mg of CBN, made to support you during long sleepless nights and let you rest while still waking up refreshed and ready to take on the day.

Because they’re made out of only four ingredients, you’ll know exactly what you’re putting in your body without any worries. The full-spectrum hemp CBD brings an entourage effect to the table, while organic CBN tackles insomnia. Plus, L-theanine eases stress and supports sleep while passion flower extract adds another boost to the sleep-inducing gummies.

Why FOCL is the #1 Name in CBN Sleep Gummies

FOCL has consistently proven that the brand is dedicated to delivering high-quality products that are effective, tackling wellness issues, and ultimately helping you live a better life by sleeping and performing better. Their commitment to gaining their customer’s trust is backed up by a devotion to quality and transparency because they believe we all deserve only the best of the best.

The founder of FOCL, Ken Lawson, was diagnosed with Chronic Fatigue Syndrome in his 20’s. After years of suffering from stress, fatigue, brain fog, joint pain, and other symptoms, he realized he had to change his life. Ken changed his diet, exercise routine, and stress management, before realizing there was something else that went a long way: CBD. Thus, FOCL was born (and we get to enjoy every bit of it).

Batch: Best CBN for Sleeping

Moving on to the coveted prize of the best CBN for sleeping, we’ve got to give it to BATCH CBD Nighttime CBD + CBN Gummies. Made to enhance and improve your nighttime routine and wake-up time, these natural raspberry-flavored gummies deliver effects and great taste.

With 25mg of full-spectrum CBD oil, another 15mg of pure CBN, 25mg of passion flower extract, plus 50mg of L-theanine, these chews’ ingredients work together to give you a stress-free, relaxing, and calm evening that’ll have you falling asleep before you can finish counting sheep.

How Batch CBD Became a Leader in CBD + CBN Gummies for Sleep

Batch CBD mixes the best of both worlds: the young and hip side of the modern cannabis world with the tradition of an old-timey farm that is dedicated to supporting local communities and creating from the heart.

All of Batch CBD hemp is home-grown in a rural Wisconsin town, where generations of farmers have used bountiful soil left unscathed by the Ice Age Glacier to farm pure and sunshine-grown crops (and now: hemp!). The brand was founded by three lifelong friends who turned a passion project into a growing business, and have consistently made their way up the food chain by creating effective, safe, and amazing products.

Green Roads: Best Broad Spectrum Sleep Gummy

Green Roads Sleepy Zs CBD + CBN Gummies are a great addition to your evening routine. Made to support sleep, which is one of the most crucial aspects of your health and well-being, these blackberry-flavored chews have 5mg of melatonin, plus 25mg of CBD and CBN. The delicious gummies are designed to make you fall asleep and stay asleep, allowing you to wake up refreshed and feel more rested and productive all day.

Dragon Hemp: Best Organic CBN Gummy

If you need a little extra help getting to sleep, turn to Dragon Hemp Sleep Gummies. These sleep-inducing gummies allow you to fall asleep and stay asleep all night, with 20mg of premium-grade CBD and 5mg of CBN that’ll have you dosing off in no time. Plus, these are a great pick for those who prefer organic products: they’re vegan, organic, and low-sugar.

Otterspace: Best-Tasting CBN Gummy

To enjoy the feeling of the moon’s light on your cheeks as you get lulled to sleep, try Otterspace Nighttime CBD + CBN Gummies. They’re here to take the night shift so you don’t have to worry about anything except trying to run faster than a slow jog in your dreams. With a lick-your-lips raspberry flavor, these are definitely one of the best-tasting gummies out there. Enjoy 25mg of CBD and 15mg of CBN to blissfully drift off.

Slumber CBN: Best Zero-Melatonin Sleep Gummy

Melatonin can be a great complement to help you fall asleep, but it isn’t for everyone. If you’re on the lookout for a melatonin-free sleep supplement, try Slumber CBN Extra-Strength CBN Gummies for Sleep. The good people at Slumber spent two years formulating and perfecting this fast-acting formula that puts 15mg of CBN into delicious and effective gummies that deliciously taste like vanilla and blueberries.

Moonwlkr: Best Vegan Sleep Gummy

Vegans, we’ve got you. Enjoy the goodness of vegan-friendly CBN with Moonwlkr CBD:CBN Sleep Gummies. One of the most potent gummies out there, these mixed-berry-flavored chews pack 10mg of CBN and 25mg of CBD per gummy. Because CBN is thought to be stronger than CBD when it comes to the sleep department, the 10mg will definitely do the trick and have you sleeping all through the night, guilt-free.

Dosed: Best Lavender-Infused CBN

Lavender has often been used to help people fall asleep, from teas to essential oils and candles. Now, enjoy lavender in gummy form with Dosed Sleep CBD:CBN Blackberry Lavender Gummies. Made to encourage sleep and restfulness, these delicious gummies use nanoblend technology to increase bioavailability, absorption, and faster onset.

Enjoy Hemp: Best High-Potency Sleep Gummy

For a Delta-8 and CBN experience, you’ll want to take a look at Enjoy Hemp Unwind Delta-8 + CBN Gummies. These high-potency gummies are filled with 40mg of Delta-8 THC and 10mg of CBN each, allowing you to enjoy an entourage effect with Indica-specific terpenes that’ll help you unwind and reduce stress. Especially good for your evening routine, you’ll be able to plop into bed and let yourself be taken away by the dream fairies faster than you can say tetrahydrocannabinol.

Dad Grass: Best Quality Sleep Gummies

If you’re looking for a super-high-quality way to take CBN, look no further than the Dad Grass Nighttime Formula CBD + CBN Gummies. These midnight berry chews are sure to lull you to sleep, with all-natural ingredients and a healthy dose of both CBN and CBD. To enjoy the fast-acting effects, just pop a gummy or two before bed and let yourself drift off into dreamland.

Sunset Lake CBD: Brand to Watch

We love seeing brands rise up through effective and high-quality products, which is why we’re giving a shoutout to Sunset Lake CBD Sleep Gummies CBN + Melatonin. These elderberry-flavored gummies are infused with a balanced blend of CBD, CBN, and melatonin that are all designed to promote a more restful and deep night’s sleep. These gummies are created naturally and organically from scratch on a Northern Vermont farm.

Kush Queen: Best CBN Blend Gummy

Kush Queen Gummies RX Sleep CBN+CBD Chews combine the magic of CBD & CBN to help you gain restorative sleep without feeling groggy in the morning. These work best when taken consistently, plus you’ll enjoy the natural berry flavor that makes it seem like anything but a chore. You’ll enjoy a healthier circadian rhythm and deep slumber that eases tossing and turning and helps you sleep through the night.

How We Made Our Choices for the Best CBN Gummies for Sleep

We made sure to keep our eye out for any red flags when making our choices for the best sleep-inducing CBN gummies.

First, we had to make sure that the brands were transparent and adhered to all safety measures, making sure to third-party lab test every product and obtaining Certificates of Authentication with safe extraction methods and effective dosage.

Next, we ensured that the values ​​of each brand aligned with our own. Transparency, trustworthiness, quality, and passion were all must-haves.

At the end of the day, we want nothing more than for you to be able to enjoy a full night’s sleep with a little help from CBN brands that want that, too. We believe in the brands we’re supporting, and we’re sure you’ll love them as well.

Buying Guide for CBN Edibles (How to Choose the Best CBN Gummies)

Here are a few tips to keep in mind when you’re looking to buy CBN gummies or any cannabis products:

  • Consider the method of consumption: while we’re focusing on gummies right now, there are many other ways to consume cannabis. Whether you’re using a topical, a tincture, edibles, oil, or even flower, make sure you’re up for it.
  • What effects are you looking for? If you don’t want to fall asleep, maybe look for other cannabinoids and terpenes that support a boost in energy. By knowing the effects you want to experience, you’ll be able to find products that work for you.
  • Checks dosages and potency: what works for one person, might not for another. You’ll want to start off with low dosages, especially if you’re new to the game. Little by little, you’ll figure out the right dosage for your needs.
  • Look out for red flags: make sure the brands you buy from comply with safety measures and are transparent about the ingredients and extraction methods that they use.

Cannabinol Frequently Asked Questions

Benefits of CBN Gummies?

While more research needs to be done, some people are using CBN to help them sleep, deal with health-related symptoms, ease pain, and reduce stress.

How Much CBN Should I Take for Sleep?

Start off with 5 mg. If you feel you need more, you can always up the dosage until you’re comfortable with the effects.

How Long Before CBN Gummies Kick In?

It depends on the person, but most people will feel the effects within 30 minutes, although it can take up to 180 minutes for the effects to set in completely.

How Long Will CBN Stay in My System?

CBN will typically stay in your system for up to five days. However, factors like your metabolism, frequency of use, amount consumed, and method of consumption can lengthen the detox process.

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There’s NO evidence marijuana or CBD oil treats pain better than placebo, major review finds 

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All smoke and mirrors? There’s NO evidence marijuana or CBD oil treats pain better than placebo, major review finds

  • Twenty studies involving 1.5k people found a placebo reduced pain just as well
  • Expecting to have relief can change the way the body perceives pain signals
  • It comes amid a US cannabis revolution with 37 states legalizing to treat pain

Marijuana and CBD have no effect on pain relief, a major review has found.

Despite pain being one of the most popular reasons for using cannabis, researchers found the products are no more effective than a placebo.

The review looked at more than a dozen studies in 11 countries involving 1,459 people from early 2000s to September 2021.

The researchers said: ‘Our team observed no significant difference between cannabis and a placebo for reducing pain.’

Official figures show around a fifth of marijuana users in the US are prescribed medical cannabis. Estimates suggest a quarter of all Americans use CBD oil, with the main reason being pain (64 percent).

It comes after researchers at Cleveland Clinic found that cannabis users were significantly more likely to suffer pain after surgery.

It comes amid a cannabis revolution in the US with more than half of states legalizing the drug for medical reasons, including the treatment of pain. A total of 21 states have permitted its use recreationally.

Compulsory labeling should be used in the cannabis industry to let users know how much THC they are smoking, experts say

Researchers from the Karolinska Institute in Sweden looked at 20 studies. Most participants were female and between 33 and 62 years old.

The majority of the experiments were carried out in the US, UK and Canada, but data from Israel, the Netherlands and the Czech Republic was also included.

A variety of pain conditions were included, such as nerve damage and multiple sclerosis, as well as a range of cannabis products — THC, CBD and synthetic cannabis — taken via pills, sprays, oils and smoking.

Results showed that pain intensity significantly reduced in response to a placebo, as did cannabis.

The research paper said: ‘Our meta-analysis showed that pain was rated as being significantly less intense after treatment with a placebo, with a moderate to large effect depending on each person.’

It added: ‘In line with general principles of human perception, expectations of (possible) pain relief can modulate sensory processing and thereby reduce the perception of incoming nociceptive signals.’

The review also found that lots of participants could tell the difference between a placebo and cannabis, even though they small, taste and look the same.

If people knew which they were receiving, this could lead them to give a biased judgment on the effectiveness of the treatment.

The study was published in the Journal American Medical Association.

The researchers’ findings corroborated a 2021 meta-analysis which found that studies where neither the researchers or participants know who is receiving the marijuana led to higher placebo responses.

It comes as a multi-state study found that pregnant women who live in US states with loose cannabis laws are substantially more likely to use the drug than women who live in places with more restrictions.

Smoking the drug while expecting puts the unborn baby at risk of premature birth and low birth weight or stillbirth as well as long-term brain development issues.

What are the health risks of marijuana?

About 48million Americans smoke cannabis at least once a year, official estimates suggest.

Marijuana is the third most commonly used drug in the US behind alcohol and tobacco.

This figure is rising as states continue to legalize the drug.

21 US states have legalized the drug for recreational use for adults.

But evidence is also growing over its health risks, particularly for young adults.

Researchers suggest it has the following negative impacts:

  • Brain damage: It can cause a permanent loss of IQ because it hinders brain development and could even have lasting cognition effects in young adults;
  • mental health: It has been linked to increased rates of suicide as well as psychiatric disorders such as depression and anxiety, although it is unclear if marijuana is the cause;
  • Daily life: Surveys link it to more problems in careers and maintaining healthy relationships;
  • Driving: Those who drive under the influence have slower reactions and less coordination, research shows.

Source: Substance Abuse and Mental Health Services Administration.

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