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

 

FDA Issues Draft Guidance on CBD Clinical Research and Submits CBD Enforcement Policy to OMB for Review

FDA Issues Draft Guidance on CBD Clinical Research and Submits CBD Enforcement Policy to OMB for Review

FDA Issues Draft Guidance on CBD Clinical Research and Submits CBD Enforcement Policy to OMB for Review

July 2020 has been a busy month in the CBD world whereby FDA issues draft guidance on CBD clinical research and submits CBD enforcement policy to OMB for review.

After much anticipation, the FDA has begun to address its policies on CBD. On July 21, 2020, FDA issued draft guidance on clinical research involving CBD-containing investigational drugs and other cannabis-derived compounds. Further, on July 22, 2020, the long-awaited draft guidance on CBD enforcement policy was sent to the Office of Management and Budget (OMB) for a review. 

To date, FDA’s movement has not officially changed the existing position on the legal and regulatory status of various CBD-containing consumer products, but more is expected. Still, the recent reports to Congress and draft guidance on investigations involving CBD and other cannabis-derived compounds do provide us with a glimpse of FDA’s current reasoning surrounding CBD.

Clinical Research Draft Guidance

On July 21, 2020, FDA issued draft guidance on quality considerations for clinical research where cannabis-derived compounds are concerned. The guidance titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research” builds off previous guidance FDA had issued regarding the quality and regulatory considerations that govern the development and FDA approval of cannabis products. The draft guidance highlights the following key points :

1. Sourcing of Cannabis

For many years, the only domestic source of cannabis for legal clinical research was the National Institute on Drug Abuse (NIDA) Drug Supply Program (DSP), but with the changes made by the 2018 Farm Bill, hemp can serve as a source for cannabis cannabis-derived compounds for drug development. This change gives the investigational drug sponsors of clinical studies new options that do not involve the NIDA DSP.

2. Quality Considerations

Sponsors of cannabis-derived compounds will be expected to provide sufficient information to ensure the identity, quality, purity, and potency or strength of the investigational product. Furthermore, there will be a requirement to provide quantitative data regarding phytochemicals present in their proposed product, such as cannabinoids, terpenes, and flavonoids. The guidance goes on to list several helpful resources from which sponsors may obtain more information about specific methodologies and other related insights. The guidance clarifies that cannabis is held to the same regulatory standards as any other botanical raw material, botanical drug substance, or botanical drug product; therefore, any FDA guidance that pertains to such items will also be helpful. 

3. THC Calculation

The guidance acknowledges some of the challenges of calculating THC and notes the importance of consulting the DEA before commencing drug-development activities. Amongst other things, the FDA recommends that sponsors calculate the THC level in their product candidates early in the development process to gain insight into its potential control status.

Cannabidiol Enforcement Policy Draft Guidance 

On July 22, 2020, the FDA sent its draft Cannabidiol Enforcement Policy to OMB for review. The scope and the contents of the document titled “Cannabidiol Enforcement Policy; Draft guidance for Industry” are not yet publicly available, but the industry is eagerly anticipating the long-awaited guidance on CBD enforcement.

While the full extent of the FDA’s intended enforcement consideration will be clear only when guidance is finally released, we expect, like many others, that FDA will focus its efforts on consumer products that carry the most significant risk to public health. Therefore, we anticipate that the enforcement guidance will focus on lawful marketing and transparency.

We will continue to monitor the FDA’s issuance of the enforcement guidance and update as soon as it passes the OMB review. Make sure to sign up to our newsletter for further updates. 

Could CBD Help Us Cope During Stressful Times?

Could CBD Help Us Cope During Stressful Times?

The Pandemic has taken its toll not only on our outer world but most certainly on our inner. Even the World Health Organization has published the dim prospect of an imminent, pandemic-related mental health crisis. It is well known that psychological stress from any origin is likely to raise the risk of depression and anxiety. The stress originating from coronavirus implications may likely come with its own mental health challenges. Chronic stress is known to weaken the endocannabinoid system (ECS), therefore making us more exposed to illness. 

With the cannabis plant’s ability to support the endocannabinoid system and research demonstrating that CBD has helped relieve various mental health symptoms, we have dug a little deeper into CBD’s effect on anxiety and depression.

CBD and Anxiety

 Could CBD help us cope during stressful times?

The link between cannabinoids and anxiety and fear has been of special interest in clinical research. 

Anxiety disorders are the most well-known mental illness in the U.S., affecting 40 million adults, or 18.1% of the population and are routinely defined by excessive worrying about things and events that manifest in physiological responses in the body.

In laboratory settings, CBD has been shown to decrease experimentally induced anxiety and lessen fear memories in healthy adult participants. Clinical trials in patients suffering from post-traumatic stress disorder (PTSD) have demonstrated that dronabinol and nabilone can reduce their symptoms.

Although CBD trials have shown limited impact on baseline levels of anxiety, it is evident that CBD reduces experimentally induced anxiety and fear. For example, one study in healthy participants and those suffering from social anxiety disorder found that CBD decreased task-related anxiety. Whereas another study implies that CBD reduces amygdala activation in case of a threat and alters functional link between prefrontal regions and the amygdala, which could explain its inherent anxiolytic effects.

While more is to be learned about CBD’s anxiolytic effect, and with clinical research moving at a slow pace, we might be a while from an official approval of CBD as an anti-anxiety solution. In the meantime, to minimize any damage to our endocannabinoid system caused by current coronavirus stress (which may make us more exposed to anxiety disorders), we could do far worse than incorporate high-grade CBD oil into our self-care regimen. 

CBD and Depression

 Could CBD help us cope during stressful times?

Depression is characterized by having a persistently low mood or loss of pleasure in regular activities for at least two weeks. Approximately 17.3 million adults in the U.S. have had at least one major depressive episode. 

Studies in animals have shown that CBD certainly improves the symptoms of depression. This is to be thought most likely due to the activation of 5-HT1A receptors in the brain.

In one study, animals were given a 5-HT1A receptor antagonist beside CBD, limiting the cannabinoid from bonding with the serotonin receptor. This seemed to prevent the mood-enhancing impact of CBD. Another study found that aside serotonin, CBD increased glutamate production, and neurotransmission resulting in immediate antidepressant-like effects. 

The current research unquestionably indicates that CBD can improve symptoms related to depression. It is hoped that more clinical data will be available soon, however, it is unmistakable that CBD for depression continues to be one of the most common reasons people turn to CBD oil.

Final Thought

CBD is inevitably a multifaceted supplement that’s becoming well established by research with more evidence emerging that shows real therapeutic benefits.

For more information and to try out our range of CBD oproducts or to see how CBD can help you cope during stressful times, head over to our store.

Is CBD Safe For Children?

Is CBD Safe For Children?

Many parents who are using CBD regularly have been reporting that it has successfully treated several ailments for them, from anxiety to pain relief, acne and many more. 

But what about giving CBD to kids? Is CBD safe for children? In this article, we will look to examine the evidence associated with the safety and therapeutic benefits of CBD use in children. 

How Is CBD Different From Marijuana?

Cannabis holds over 100 different chemicals known as cannabinoids. The primary psychoactive element in cannabis is delta-9-tetrahydrocannabinol (THC), which creates euphoria, shifts in perception and mood, as well as provides an improvement in appetite. In contrast, CBD solely offers a level of sedation, without the psychoactive results connected with THC.

Marijuana is made of the dried petals, stems, and leaves of the female cannabis plant and holds between 3% – 20% THC. Various subspecies contain varying ratios of THC to CBD, with the most significant ratios in Cannabis sativa, and the weakest in Cannabis indica. 

“Hemp” is the terminology applied to distinguish varieties of cannabis holding 0.3% or less of THC and is the base of most CBD stocks accessible commercially. 

THC works by binding to 2 cell membrane receptors, named the cannabinoid type 1 (CB1) receptor and type 2 (CB2) receptor. Cannabinoid type 1 receptors are primarily concentrated in brain tissues, and CB2 receptors are located in immune and hematopoietic cells. Through its impacts on these receptors, THC influences pain, anxiety, perception, memory, learning, and motor control.

On the other hand, CBD does not influence CB1 and CB2 receptors and applies its sedative nature by altering numerous other neurotransmitters. It also has been illustrated to decrease the euphoric effects of THC by inhibiting its influence on the CB1 and CB2 receptors and changing the metabolism of THC.

The Evidence For CBD Health Benefits

CBD is being  praised for its benefits in treating various health issues, but the most reliable scientific testimony is for its potency in treating some of the most brutal childhood epilepsy syndromes, such as Dravet syndrome and Lennox-Gastaut syndrome that do not generally respond to anti seizure remedies. In various studies, CBD has demonstrated the effectiveness of reducing the number of seizures, and in some cases, even stopping them entirely. The Food and Drug Administration (FDA) has already approved cannabis-derived medicine, the cannabidiol drug Epidiolex, which can help reduce symptoms of epilepsy. 

Another study published in JAMA Neurology approved prior study results describing the effectiveness of this treatment for Dravet syndrome at a dosage of 20 mg per kg per day. The trial, which involved 199 patients aged between 2 and 18 with a diagnosis of Dravet syndrome, recorded that the 10mg dose might be equally as efficient as the 20mg dose. Experts observed that those who took 10mg experienced seizure declines of 49% contrasted with 46% decrease in those who took 20mg and a 27% decrease for those who took a placebo.

The Epidiolex examinations present evidence that CBD in proper dosages can be effective for seizures in children diagnosed with Dravet syndrome and Lennox-Gastaut syndrome. Epidiolex may also confirm to be a valuable antiepileptic treatment for refractory seizures in additional conditions. 

With some of the benefits of cannabidiol already recognized, Pharmaceuticals are continually seeking the approval from FDA for the treatment of patients who have multiple sclerosis, autism, schizophrenia, spinal cord spasticity, and PTSD (post-traumatic stress disorder).

There are currently a significant amount of ongoing clinical trials concerning the use of CBD products for conditions that involve various conditions such as refractory seizures and anxiety, feeding the hope that soon, we will have more clinically approved data upon which to base the evidence of CBD health benefits. 

How Safe Is CBD For Children?

A report from the World Health Organization affirms that in humans, CBD exhibits no effects indicative of any abuse or dependence potential. The report goes on to state that, to date, there is no evidence of public health-related problems connected with the application of pure CBD.

However, if you are new to using CBD or if you are uncertain if CBD is right for you and your family, do make sure that you take advice from a medical practitioner or an expert in the CBD field. A good starting point would be your family doctor; however, you must bear in mind that many medical professionals are still unfamiliar with CBD products and there is still a large degree of stigma attached to the subject. Equally, you may wish to conduct independent research online or perhaps look to consult with long-standing experts and reputable advocates in the CBD industry.    

It is also sensible to always apply caution when purchasing CBD online.  There are many reputable CBD providers online, but not all brands are bound by appropriate ethical standards, mainly due to the lack of regulation in the industry. Therefore, you should conduct relevant research and make sure that the products you purchase contain the advertised dosages. Only purchase CBD online from a reputable and ethical brand, and remember that the size of the company does not necessarily indicate their commitment to prioritization of quality. Never purchase a CBD product without making sure that you have read the third-party lab report. 

CBD Edibles For Children To Try 

If you are looking to introduce CBD in your family lifestyle, you might wish to begin by introducing products in sweetened forms. Children are likely to tolerate these much better than oil droppers.

Products, such as Bolder Caramels  are made of hemp oil-infused coconut milk, palm sugar, sea salt and phytochemical-rich extracted hemp oil. The delicious artisan-crafted caramels offer a delicious way to enjoy CBD.