FDA Approves New Indication For Drug Containing An Active Ingredient Derived From Cannabis To Treat Seizures In Rare Genetic Disease

DISTRICT OF COLUMBIA: Last month, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex was previously approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). This is the only FDA-approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with TSC.

CBD is a chemical component of the Cannabis sativa plant. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of cannabis.

“The FDA continues to believe the drug approval process represents the best way to make new medicines, including any drugs derived from cannabis, available to patients in need of appropriate medical therapy such as the treatment of seizures associated with these rare conditions. This paradigm ensures new therapies are safe, effective, and manufactured to a high quality that provides uniform and reliable dosing for patients,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “The agency is committed to supporting rigorous scientific research on the potential medical uses of cannabis-derived products and working with product developers who are interested in bringing patients safe and effective, high quality products.”

TSC is a rare genetic disease that causes non-cancerous (benign) tumors to grow in the brain and other parts of the body like the eyes, heart, kidneys, lungs, and skin. TSC usually affects the central nervous system and can result in a combination of symptoms including seizures, developmental delay, and behavioral problems, although the signs and symptoms of the condition, as well as the severity of symptoms, vary widely. TSC affects about 1 in 6,000 people.

Epidiolex’s effectiveness for the treatment of seizures associated with TSC was established in a randomized, double-blind, placebo-controlled trial where 148 patients out of a total of 224 in the study received Epidiolex. The study measured the change from baseline in seizure frequency. In the study, patients treated with Epidiolex had a significantly greater reduction in the frequency of seizures during the treatment period than patients who received placebo (inactive treatment). This effect was seen within eight weeks and remained consistent throughout the 16-week treatment period.

The most common side effects that occurred in Epidiolex-treated patients with TSC in the clinical trial were: diarrhea, elevated liver enzymes, decreased appetite, sleepiness, fever, and vomiting. Additional side effects for patients with LGS, DS, or TSC include: liver injury, decreased weight, anemia, and increased creatinine.

Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for all drugs that currently treat epilepsy, including Epidiolex, the most serious risks may include an increase in suicidal thoughts and behavior, or thoughts of self-harm. Patients, their caregivers, and their families should be advised to monitor for any unusual changes in mood or behavior, such as worsening depression, suicidal thoughts or behavior. Patients, caregivers, and families should report behaviors of concern immediately to healthcare providers. Epidiolex also caused liver injury in some patients. Most cases were generally mild, but a risk of rare, but more severe liver injury exists. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice, and/or dark urine.

The FDA granted Priority Review designation for this application. The approval of Epidiolex was granted to Greenwich Biosciences Inc., of Carlsbad, California.

The First Cannabis IP-Licensing Company, Breeder’s Best, Officially Launches

New company brings together cannabis industry leaders including attorney-scientist Dale Hunt, researcher-physician Ethan Russo, and botanist-author Robert C. Clarke

CALIFORNIA: Cannabis industry pioneers, Dale Hunt, PhD, JD, Ethan Russo, MD, and Robert C. Clarke have joined forces to create Breeder’s Best, the first cannabis company to focus on intellectual property (IP) protection for independent plant breeders and licensing IP for access to markets worldwide. Breeder’s Best brings a global plant-licensing model, proven successful in other agriculture industries, to cannabis.

The liberalization of global cannabis laws and growing public acceptance of cannabis have created a rapidly escalating demand for cannabis flower, as well as therapeutics and products made with cannabis. According to a report by Prohibition Partners, the international cannabis industry is projected to grow to more than $103.6 billion by 2024.

While the cannabis industry presents significant opportunity, there exists a critical disconnect that separates the creativity of breeders from the markets that are demanding products with unique and proven genetic profiles. Additionally, there is typically very little IP protection to support good partnerships between breeders and cannabis brands. Breeder’s Best will connect these two key stakeholders while legally protecting the genetic inventiveness of breeders.

Breeder’s Best founder and CEO Dale Hunt says, “Our mission is to connect the best Cannabis genetics to the greatest needs and most promising commercial opportunities. To do that, we have assembled an unparalleled team of experts with deep experience at every level of the cannabis supply chain. As the industry matures, Breeder’s Best will be positioned to meet the demands of the increasingly professional and GMP-oriented marketplace while doing business in a way that benefits breeders and directs profitable and reliable business to growers who may otherwise be left behind. With our vision, team, model, know-how, and relationships, Breeder’s Best is poised to become the global leader in patented cannabis genetics and related products.” Dr. Hunt has been practicing IP law for 23 years. He has a PhD in plant cellular and molecular biology and has obtained thousands of patents and plant variety rights for his clients in more than 30 countries.

“Cannabis use is finally normalizing. At Breeder’s Best, we present independent Cannabis breeders the opportunity to protect their unique varieties and assist them in placing those genetics in lucrative markets. This is a great service to breeders who would prefer to focus on the art and science of breeding, instead of dealing with the mechanics of commercialization,” said Breeder’s Best Director of Agronomy and Genetics, Robert C. Clarke. Mr. Clarke is a 40-year cannabis industry veteran, revered for his books Marijuana Botany, published in 1982, and Cannabis: Evolution and Ethnobotany, published in 2013.

The Cannabis plant produces over 450 chemical components, many of which are potentially therapeutic. However, decades of cannabis prohibition have resulted in a lack of genetic diversity worldwide and a predominance of only a small fraction of potential agents.

“We have just begun to scratch the surface of everything that cannabis can do to improve and enhance our lives,” said Dr. Ethan Russo. “That’s what Breeder’s Best will do. Identifying, selectively breeding for and utilizing specific chemical components will truly transform medicine in the coming decades.” Dr. Russo is a board-certified neurologist, preeminent medical cannabis expert, author of more than 50 peer-reviewed medical journal articles and a veteran of GW Pharmaceuticals where he served as Senior Medical Advisor as well as the Sativex® and Epidiolex® clinical trial Study Physician and Medical Monitor.


About Breeder’s Best:  Breeder’s Best is a privately held Cannabis IP genetics company organized as a B Corporation to demonstrate our commitment to independent Cannabis breeders and to meeting the worldwide needs of patients and consumers for superior products. To learn more about Breeder’s Best visit www.breedersbest.com.

Hot Pot Stocks: Aurora Cannabis vs. GW Pharmaceuticals. Which Cannabis Stock To Buy?

By Cristine Felt 

Aurora Cannabis vs. GW Pharmaceuticals: Which Cannabis Stock To Buy?

In this time and age when cannabis industry is simply blooming, it appears even an inexperienced rookie could try their hand at buying cannabis stocks and shares without the slightest fear of losing. Indeed, the global market is thought to be worth some astonishing $150 billion, with the prognosis of hitting $272 billion by 2028. You may have envisioned that world popular “shut up and take my money” meme already, but it’s not that simple (as usual). Stocks rise and fall, so it’s best to rely on the companies that have been around for a while and are doing a pretty good job, to say the least – Aurora Cannabis and GW Pharmaceuticals.

But which one is a tad better? Let’s make a brief comparison.

Aurora-Cannabis-LogoAurora Cannabis

Aurora Cannabis is a Canadian cannabis producer which was founded in 2013. The company deals with the production and distribution of medical and recreational cannabis. Just saying their business is based in Canada speaks volumes. Ever since the country has legalized cannabis use in October last year, the sales have been rising, and it was excellent news for experienced players such as Aurora Cannabis.

They had a 20% market share in the last quarter of 2018. As one of the largest marijuana producers, and with expectations to produce astounding 500,000 kilograms in the near future, it appears they are a force to be reckoned with. Moreover, Aurora is Germany’s main cannabis supplier, and this European country is expected to follow Canada’s suit soon. In addition, it also exports products to 20 other countries in five continents. What is more, the announced shortage of cannabis supply is without a doubt an excellent opportunity for the company. Their latest market cap is $9.042B.

But, what about the drawbacks?

For one reason, their overall business in 2018 was not as stable as it may have seemed. Their general performance was quite disappointing, and they were listed as one of top five worst Canadian cannabis stocks. The last quarter turned out great due to the consequences of the messy legalization, which Aurora benefited from.

gwphGW Pharmaceuticals

On the other hand, we have a British biopharmaceutical company and a true pioneer in the industry. They are globally well-known due to a product of theirs called Sativex, an oral spray that is extensively used in the treatment of multiple sclerosis. They reaped huge success with it, and it is sold as a prescription drug in the UK, EU, New Zealand, Israel and Canada. GW Pharmaceuticals was set up in 1998, and their vast research experience is bearing fruit once again with the latest breakthrough in medical cannabis industry in the form of Epidiolex. In its essence, this drug is a purified CBD, and one of the reasons why Epidiolex is a revolutionary prescription drug is the fact that it was recently approved by the U.S. Food and Drug Administration for patients suffering from different types of seizure. Bearing in mind its CBD content, this is definitely an unprecedented event. Obviously, the company has made a huge step into the US market and was recognized as trustworthy (even 2-year-olds are can be prescribed Epidiolex). Naturally, the sales are expected to skyrocket and reach $1 billion per year, or even $2 billion. By the way, GW Pharmaceuticals market cap is 5.131B.

So, everything seems to be going great, but… What the company did not prepare for, and it is a bit surprising bearing in mind their experience, is the huge demand for the new drug which has surpassed the expectations and caused the shares to drop by 3% (!). Which is worse, the doubt in their business management was triggered by a simple tweet of a dissatisfied father. It makes one wonder if GW Pharmaceuticals can rise to the challenge.

Taking everything into consideration, we believe that GW Pharmaceuticals’ future shines a bit more brightly than Aurora Cannabis’. The latter is definitely a huge producer and distributor, but GW Pharmaceuticals seem to be producing medical cannabis of such high quality that even the FDA had to approve of it. After all, the winners have always been those who were able to offer something unique, extraordinary and extremely high-quality, no matter the industry, and GW Pharmaceuticals appear to be one of them.

FDA Approves Marketing Of Plant-Derived Marijuana Medicine

DISTRICT OF COLUMBIA:  Regulators at the US Food and Drug Administration on Monday granted market approval to Epidiolex, a prescription medicine containing a standardized formulation of plant-derived cannabidiol (CBD) for the explicit treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

The proprietary extract formulation – developed by the British biotechnology firm GW Pharmaceuticals – had demonstrated safety and clinical efficacy at reducing seizure frequency in several placebo-controlled trials. It is the fourth marijuana-based medicine to receive US FDA approval – joining dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros). However, Epidiolex is the first FDA-approved medicine containing plant-derived, non-synthetic cannabinoids.

Commenting on the agency’s decision, NORML Deputy Director Paul Armentano said: “We anticipate that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant. Nonetheless, these alternatives should not be regulated as options to replace the use and regulation of herbal cannabis – a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 30 states.”

Federal agencies have 90 days to determine the scheduling of Epidiolex under the US Controlled Substances Act. According to the New York Times, analysts expect Epidiolex to cost patients between $2,500 and $5,000 a month.

Despite the FDA’s approval of Epidiolex, the agency acknowledged in a statement that the cannabidinoid CBD still remains classified at this time as a schedule I controlled substance, and that the agency is “prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.” FDA Commissioner Scott Gottlieb further added: “This is the approval of one specific CBD medication for a specific use. … [T]his is not an approval of marijuana or all of its components.”


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org.

FDA Approves First Cannabis-Based Epilepsy Drug

MARYLAND: The U.S. Food and Drug Administration has approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.

CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of marijuana.

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures). Later, other types of seizures typically arise, including myoclonic seizures (involuntary muscle spasms). Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others.

Lennox-Gastaut syndrome begins in childhood. It is characterized by multiple types of seizures. People with Lennox-Gastaut syndrome begin having frequent seizures in early childhood, usually between ages 3 and 5. More than three-quarters of affected individuals have tonic seizures, which cause the muscles to contract uncontrollably. Almost all children with Lennox-Gastaut syndrome develop learning problems and intellectual disability. Many also have delayed development of motor skills such as sitting and crawling. Most people with Lennox-Gastaut syndrome require help with usual activities of daily living.

“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”

Study: CBD Extracts Significantly Reduced Seizure Frequency In Children With Refractory Epilepsy

ISRAEL: The adjunctive use of CBD extracts is safe and effective in adolescent patients with refractory epilepsy, according to clinical data published online ahead of print in the journal Brain & Development.

Israeli researchers assessed the sustained daily use of extracted CBD oils in a cohort of young patients with treatment resistant epilepsy.

Thirty-five percent of participants experienced a reduction in mean monthly seizure frequency of 75 percent or greater following CBD treatment. Forty-one percent of patients either partially or completely tapered their use of anti-epileptic drugs during the study period due to improvements in their condition. Patients who were younger than ten years of age at treatment onset experienced higher improvement rates compared to older subjects. The most commonly reported adverse side-effect of CBD treatment was somnolence, which was reported in 14 percent of patients.

Authors concluded, “In concordance with recent encouraging evidence, this open-label study using parental report, showed that CBD- enriched cannabis extract appears to have potential anti-seizure effect as an add- on treatment in pediatric patients with refractory epilepsy, with a favorable safety profile.”

The findings are similar to those of other recent trials reporting that the use of CBD extracts reduces seizure frequency and improves other symptoms of epilepsy. Regulators at the US Food and Drug Administration are anticipated to grant market approval this summer to a proprietary formulation of CBD oil, known as Epidiolex, for the treatment of Dravet syndrome and Lennox-Gastaut syndrome, two types of severe pediatric epilepsy.


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Efficacy of CBD-enriched medical cannabis for treatment of refractory epilepsy in children and adolescents – An observational, longitudinal study,” appears in Brain & Development.

FDA Grants ‘Priority Review’ Of Plant-Derived CBD Extract

DISTRICT OF COLUMBIA: Representatives of the US Food and Drug Administration will undertake a ‘priority review‘ of data specific to the safety and efficacy of Epidiolex, a standardized, plant-derived CBD extract formulated by a British pharmaceutical company. The review is scheduled to be completed by June 27, 2018.

Phase III clinical trial data shows that Epidiolex administration reduces seizure frequency in various hard-to-treat conditions, such as Lennox-Gastaut syndrome and Dravet syndrome.

To date, the FDA has approved three marijuana-based pharmaceuticals – dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid dronabinol (aka Syndros). All three of these products primarily consist of synthetic forms of THC.

If Epidiolex achieves FDA-approval, analysts suggest the product could retail for between $30,000 to $60,000 annually.


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org.

Study Confirms Safety Of Cannabis Drug CBD

NEW YORK:  Using a drug based on a chemical found in the cannabis plant to treat epilepsy has been controversial to say the least. An early study from the US may lend more weight to its scientific standing, however. The study suggests that the drug is safe, well-tolerated and effective.

An early American study has assessed the safety of Epidiolex – the drug made from cannabidiol (CBD), a compound derived from cannabis.

The study was conducted by Dr Orrin Devinsky, director of the New York University Langone Comprehensive Epilepsy Center. It was designed to test the safety of Epidiolex and how well people could tolerate it.

Georgia Boy Among First To Receive Experimental Medical Marijuana Drug

GEORGIA:  A 7-year-old boy is one of the first people in the country to receive a potent form of medical marijuana as part of an “extended use” clinical trial to reduce seizures.

Preston Weaver, who lives in Athens, Georgia, has Lennox-Gastaut syndrome which is a severe form of epilepsy. He experiences up to 100 seizures a day, although many are confined to his brain and aren’t noticeable to an observer. There is no known cure for the condition.

Many of the drugs available to treat the syndrome don’t work long term, especially for children. Even with more than a dozen medications Weaver has had no relief.

The active ingredient in Epidiolex, the experimental drug that Weaver and one other child are receiving, is called cannabidiol. It’s also the main active ingredient in marijuana though it doesn’t produce a high.

GW Pharmaceuticals Closes U.S. Public Offering; Cannabis-Based Medicines Progress

NORTH CAROLINA:  Yesterday, Salisbury, UK-based GW Pharmaceuticals plc announced the closing of its public offering of 1.7 million American Depositary Shares on the NASDAQ Global Market. When taken together with the full exercise of options for another 255,000 ADSs by the underwriters at $86.83/ADS, the offering totaled $169.8 million.

Although some of the ADRs were sold by current shareholders, the company still grossed $126.3 million before discounts and expenses.

The funds come at a time when its flagship product,Sativex®, garnered a FDA Fast Track designation–after its approval in several other countries as early as 2005–and its Epidiolex® cannabidiol (CBD) formulation received orphan drug designation for severe, intractable epilepsy syndromes in infants and young children.

Coincident with the conclusion of GW’s stock offering yesterday, the North Carolina State House of Representatives is advancing a bill that would explicitly permit patients and their families to obtain a CBD-enriched oil (10% or more) with no more than 0.3% THC, the primary psychoactive constituent.