FDA Approves Epidiolex (cannabidiol) Oral Solution to Treat Seizures Associated with Tuberous Sclerosis Complex

FDA Approves Epidiolex (cannabidiol) Oral Solution to Treat Seizures Associated with Tuberous Sclerosis Complex

In a Press Release published July 31, 2020, the Food and Drug Administration (FDA) approves Epidiolex (cannabidiol) Oral Solution to Treat Seizures Associated with Tuberous Sclerosis Complex (TSC).  It was confirmed that Epidiolex can now be prescribed for seizures associated with TSC in patients one year or older.

The FDA previously approved Epidiolex as the first drug that contains a purified drug substance derived from cannabis. In 2018, after reviewing three clinical trials, the CBD solution was found to be a safe and effective treatment for patients aged two years or older who were suffering from Lennox-Gastaut and Dravet syndrome, being severe forms of epilepsy. 

FDA has now approved the third indication – TSC related seizures, to the list conditions treatable by Epidiolex and expanded the patient age range to allow children over the age of one suffering with Lennox-Gastaut or Dravet syndrome to access the treatment.

“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 in a statement. “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.”

GW Pharmaceuticals, the manufacturer of Epidiolex, announced on Monday, August 3, 2020, confirming that the FDA had approved EPIDIOLEX oral solution as a treatment for seizures associated with TSC.

“FDA approval of this new indication is exciting news for those with refractory seizures due to tuberous sclerosis complex,” said Justin Gover, GW’s Chief Executive Officer in a statement. Since EPIDIOLEX is already available to patients by physician’s prescription, patients with TSC can immediately access the medication. This label expansion, including the expansion of the age range in all approved indications, further demonstrates that the FDA process can continue to enable broader patient access to appropriately tested regulatory approved cannabinoid medicines. It also provides hope for these patients and their families and is yet another important milestone for EPIDIOLEX as a first-in-class antiepileptic drug.”

About Tuberous Sclerosis Complex (TSC)

According to Tuberous Sclerosis Alliance, TSC is Affecting approximately 50,000 in the United States and 1 million worldwide. TSC is a genetic disorder that causes non-cancerous tumors to form in vital organs; it is also the leading genetic cause of epilepsy and autism.

“Up to 85 percent of those affected by TSC experience seizures at some point in their lifetime,” explained TS Alliance President & CEO Kari Luther Rosbeck in a statement. “Unfortunately, existing medications don’t always effectively control them. Our organization and the TSC community certainly welcome a new option such as Epidiolex, which is the second FDA-approved drug specific to TSC.”

At least two children born each day will develop TSC, with an estimated rate of one in 6,000 newborns. People with TSC may experience a variety of seizure types. One of the most common is infantile spasms that typically present in the first year of life. The condition causes mostly benign tumors to grow in vital organs of the body (such as the brain, heart, skin, eyes, lungs, and kidneys) and is a leading cause of genetic epilepsy. People with TSC may experience a variety of seizure types. TSC is associated with a greater risk of autism and intellectual disabilities, with its severity varying widely. In some patients, the symptoms can be very mild, while others may experience serious complications. Many people with TSC live healthy and independent lives while enjoying challenging professions such as doctors and lawyers. The severity of the various aspects of TSC varies widely between patients, even between identical twins.

About EPIDIOLEX

EPIDIOLEX (cannabidiol) oral solution, a pharmaceutical formulation of highly purified cannabidiol (CBD), is an anti-epileptic medication with a novel mechanism of action. It is the first prescription, plant-derived cannabis-based medicine approved by the FDA. EPIDIOLEX has been indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients one year of age and older. 

Further information about EPIDIOLEX is available at Epidiolex.com.

New Program Launched To Standardize Cannabis Testing Methods

New Program Launched To Standardize Cannabis Testing Methods

The National Institute of Standards and Technology (NIST) has announced that a new program launched to standardize Cannabis testing methods and to aid commercial and forensic laboratories to accurately measure chemical compounds in marijuana, hemp, and other cannabis products.

The aim of the Cannabis Quality Assurance Program (CannaQAP) is to achieve accuracy in product labeling and help laboratories to distinguish between hemp and marijuana. 

While the labels on most cannabis products illustrate the concentration of tetrahydrocannabinol (THC) and cannabidiol (CBD), without official testing methodology, laboratories can often differ in their testing techniques, in turn, providing ’unreliable’ results. 

It is therefore primarily the inconsistencies in testing results that the researchers at NIST are looking to address in the course of the program.

“When you walk into a store or dispensary and see a label that says 10% CBD, you want to know that you can trust that number.” —NIST research chemist Brent Wilson

To achieve the program’s objective, NIST is looking to partner up with a range of hemp testing laboratories. The first point of the CannaQAP effort will consist of NIST sending out hemp oil samples to the participating laboratories and asking them to measure the total of CBD and THC using their routine testing methods. Each lab will then test the oils and relay its results and techniques back to the NIST researchers. It is expected that further exercises will include the testing of plant material samples.

The data collected from the participating laboratories will then be evaluated. NIST is looking to publish the data anonymously so that the participating laboratories’ names are not revealed. Research chemist Melissa Phillips has stated: “Anonymity means that labs don’t have to worry about how their performance will be viewed. Our goal is to help labs improve, not to call them out.”

While the laboratories will not be named, the results will show how much variability there is between them. Furthermore, NIST is looking to publish the correct measurements, so that each laboratory can see how accurate its measurements were and how it performed compared to its peers.  

Once NIST researchers can review the results, and evaluate the scope of the inconsistencies, they will be in a much better position to issue guidance on best practices for cannabis testing. 

NIST has said it will be developing a standard hemp reference material, which will provide accurate measurement values that labs can use to validate their testing methods. One reason these measurements vary so much is that there are currently no reference materials for cannabis.

Finally, it is understood that the new federal CannaQAP endeavour might go beyond legal hemp products. “NIST is also planning to conduct future exercises with ground hemp and possibly marijuana,” the agency has indicated. “Those exercises will involve measuring a larger number of compounds, including terpenes—the chemicals that give different strains of marijuana their distinct aromas—and compounds that people don’t want in their cannabis such as fungal toxins, pesticides, and heavy metals. Future exercises may also include extracts, concentrates, distillates, and edibles.”

We will continue following the program and will provide updates as soon as new data comes to light. Be sure to subscribe to our newsletter to stay in the know.  Laboratories that are interested in participating in the program can find more information and register online

 

CBD Oil – How Is It Made?

CBD Oil – How Is It Made?

CBD Oil – How is it made? CBD or Cannabidiol has been trending in many product industries due to its versatile capabilities to influence health conditions such as pain, anxiety, inflammation, or stress. In this article, we will look at the process of how CBD oil is made. 

Phase 1: Growing

The growing phase is governed by various regulations, depending on the location where the farming takes place. This stage strives to deliver a high-class natural strain of hemp. 

In the growing process, the quality of soil is paramount, whereby the soil nutrient content and the soil texture need to be considered.  The best soil for growing hemp is usually loose, has high fertility and plenty of organic matter. Hemp is a plant that is capable of the phytoremediation process. This means that hemp will absorb whatever is in the soil it has been planted in. Hemp is so proficient at phytoremediation that it has been planted at the Chernobyl Nuclear Disaster location to extract radioactive waste from the soil

Hemp can be grown direct from seed or cloned from parts of the plant tissue. These parts can then develop their root systems and grow plants that are genetically identical to the real plant, which can grow year after year. Cloning provides for the swift production of vast numbers of genetically equal hemp plants. Some growers favor this method because it ensures the quality of every plant. While seeds are more straightforward to obtain, hemp clones can offer excellent consistency when it comes to hemp farming.  

Hemp plants are usually grown to readiness while being spaced well apart. This planting method has been developed explicitly for harvesting hemp for CBD oil. The plants are spread out to their mature size, and natural light nourishes the entire plant producing rich healthy plants.

Phase 2: Harvesting 

When the hemp plants have matured, they are harvested and spread out evenly in large warehouse spaces to dry out. The dry hemp is then milled to create a fine corse powder with a texture similar to coffee grounds. The procedure usually follows the specific standards of the industry. The product is then transferred to the manufacturing and processing facility.

Phase 3: Extracting 

The extraction phase is the process of separating cannabinoids from biomass. Many extraction solvents can be used to separate and collect the essential oils and compounds from the hemp. Producers routinely utilize a carbon dioxide (CO2) process, which utilizes non-toxic fluid CO2 as a solvent. 

To extract all the desired materials, the solvent is forced through the ground plant material. This pulls out the CBD, essential oils, and beneficial compounds. The dissolved ingredients must then be run through a highly engineered filtration system.

Phase 4: Distilling

This phase is the separation of cannabinoids components from their impurities such as terpenes and plant material via vacuum-assisted evaporation. Specialized equipment must be designed and calibrated in order to distill the hemp ingredients at the appropriate pressure, temperature, and vacuum frames in order to limit the degradation of the product. A high vacuum is favored to minimize the requirement for heat, which can degrade those delicate cannabinoids or change the overall activity profile.

Another key point of distillation is the decarboxylation process. In its natural form. CBD is not bioavailable or effective until it is heated lightly, and the acid group is removed, thus leaving the CBD molecule. The other significant results of the distillation process involve purification of all the additional cannabinoids, separating the terpenes, and removing what is left of the remaining impurities.

Phase 5: Isolating

The image of a further refined substance from the distillation phase is a purified, crystal white cannabidiol. In its truest form, these isolates are white crystalline particles comprised of 99%+ cannabidiols. All additional cannabinoids, plant materials, terpenes, chlorophyll, and oil is separated in the production of this powder. All that remains is naturally sourced CBD crystals that bear no odor or flavor. Consumers usually find CBD isolates attractive due to them being THC free. 

Phase 6: Adding a Carrier Oil 

Once the CBD is completely processed, a carrier oil can be added to make for more comfortable administration and to improve the bioavailability, meaning that the body will consume and absorb the cannabidiol to its complete potential.

Oils that consist of medium-chain triglycerides, such as fractionated olive oil, hemp seed oil, and coconut oil, constitute the most suitable carriers. These oils will not reduce the pureness of the oil by altering the taste or vital properties.

The carrier oil provides advantages of their own. For instance,  coconut oil can produce an energy lift and deliver the cannabinoids to the bloodstream faster. Hemp seed oil provides a helpful blend of fatty acids, and olive oil has a wonderful flavor.

The liver directly absorbs the compounds, and the body instantly metabolizes them into the bloodstream together with the CBD. 

Phase 7: Laboratory Testing

Once a carrier oil is added, the CBD oil is ready to be bottled, and a sample from each batch is sent for analysis by a third-party lab. The results of this analysis present a guarantee of the quality of the CBD oil.

Routinely the certificates of analysis will inform you of how much of particular cannabinoid is present in the oil. The most dependable labs also offer a terpene profile and the results of contaminant analysis.

Conclusion 

The entire CBD oil manufacturing process, when done in accordance with the best industry practices, is quite the harmonized chain of events. Each and every phase of the process carries its own challenges that result in high quality, pure CBD oil.

How a CBD oil is made presents a suggestion of its quality. CBD brands that are operating with transparency at the forefront of their culture will often produce and stock the best quality oils. The more information and evidence of good practice available for consumers to review, the better the chance that it is an exceptional CBD oil.