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. 

CBD Interaction with Autism

CBD Interaction with Autism

CBD and Autism

People who have autism are generally faced with the reality of numerous medications for a plethora of different accompanying issues. Many parents and people who have autism have turned to CBD as a plant-based alternative to the pharmaceuticals they are prescribed. With CBD products being a newer mainstream concept, research is minimal thus far. With an eye towards education, we have explored and compiled all the information we could find surrounding CBD interaction with autism.

As there is no medication that treats or cures autism, similarly CBD doesn’t treat autism itself, but studies show it can help to alleviate the symptoms that accompany this condition.

Autism

Autism, or autism spectrum disorder (ASD), refers to the range of conditions that affect people through their social skills and communication, and is often characterized by repetitive behaviors and speech and nonverbal communication. This condition is a spectrum disorder, meaning that individuals with ASD can range from mild or moderate symptoms to more severe, requiring constant support.

Areas commonly affected by this condition include gastrointestinal disorders, seizures and sleep disorders. Anxiety, depression and attention deficits are usually present.

People with autism typically have a long list of daily medications, which can cause more problems than they solve. This lends itself to more parents and caregivers turning to CBD for alternative treatment, exploring CBD interaction with autism.

Mental Health

Anxiety and depression are commonalities seen in those diagnosed with autism. Many are put on mood stabilizers to combat these symptoms, which have countless negative side effects.

As of late, cannabis has been claimed as a top contributor for easing anxiety amongst the masses, and recent research has started to back these claims. CB1 receptors have been among the neurological transmitters targeted by anti-anxiety medication, as they play a key role in regulatory systems. Cannabinoids such as CBD function as the direct agonist to these receptors, creating an exciting pathway to aiding in this issue.

A study completed in Israel with children with autism around the age 11 concluded that 47% of these patients had lessened anxiety related symptoms. This is significant because it gives hope to those relying on harsh medications that have previously been their only option.

Another study completed with adults who have anxiety showed just under 80% of patients reported improvement in their anxiety levels after just two months of treatment using this cannabinoid.

Communication is a cornerstone concern for individuals that have autism. Verbal and nonverbal communication is commonly targeted in therapies for autism spectrum disorder. These issues can be directly related to anxiety, therefore affected by the same CB1 receptors that CBD has impact on. In a study completed in Brazil on 18 patients diagnosed with autism, communication was reportedly one of the strongest improvement areas.

Health Problems

People who have autism suffer from numerous health problems associated with this condition. An autism diagnosis is commonly synonymous with gastrointestinal problems, seizures and sleep disorders, among others.

As mentioned in our previous blog, cannabinoids like CBD interact with CB2 receptors to help regulate our body’s homeostasis. CBD interacts with regulatory function of the immune system, which can affect diseases with gastrointestinal symptoms. Studies show that a high CBD intake perpetuates regulation of these functions, decreasing symptoms that accompany gastrointestinal problems.

Seizures are also common in patients with autism. Many studies indicate a positive response from individuals with seizure disorders, with one medication currently on the market derived from cannabis.  Seizures occur due to electrical dissonance in one’s brain. CBD works to decrease the amount of excitatory neurotransmitters released to the brain, which lessons possible risk for a seizure. Understanding this concept, CBD has been worked into the pharmaceutical industry through Epidiolex, the first ever CBD drug approved by the FDA. This was specifically designed to treat people with treatment resistant epilepsy disorders, and the success rates quickly showed substantial reduction in seizures.

Individuals with autism spectrum disorder can be plagued by sleep disorders and dysregulated sleep patterns. Hyperactivity and aggression can stem from these sleep related issues. CBD can help mitigate this through affinity towards the CB1 receptors within our systems help to regulate proper sleep.  In a study conducted in Israel, children with autism were given CBD to treat comorbid symptoms of the condition. Results showed that over 70% of the patients studied had improved sleep habits.

CBD has been touted as a cannabinoid assisting in mental health therapy and specific health issues through anecdotal evidence for a while. The symptoms of autism are directly in line with the commonalities CBD has been claimed to treat. This lends itself to a hypothesis and a hope that alternative treatment for autism spectrum disorder is on the horizon.

Recent research has pointed in the positive direction for those growing wary of the multitude of pharmaceutical drugs associated with an autism diagnosis. As always, consult your doctor regarding CBD interaction with autism before including CBD treatment into your daily regimen when treating symptoms of autism.

CBD and Digestive Health

CBD and Digestive Health

CBD and Digestive Health

Digestive problems seem to be running rampant in today’s health community. Diagnoses like IBD, Crone’s, and leaky gut are becoming more prevalent. Many individuals have seemed to find relief from utilizing CBD in their daily routine, many finding correlation between CBD and digestive health.

The Endocannabinoid system in our bodies helps to regulate a whole host of functions, one of which is the immune system. Our first line of immune defense is our digestive tract, primarily the gut. This is why when we get sick we tend to notice gastrointestinal issues first. Many people with autoimmune diseases not primarily characterized with digestive problems still experience gastrointestinal discomfort. This is because their immune system is not functioning the way it should, thus their gut is not happy with them.

The Immune System

Cannabinoids help to regulate the immune system by interacting with CB2 receptors in our bodies. They activate cannabinoid receptors that aid in homeostasis, making sure our bodies are responding appropriately to different situations. CB2 receptors are found throughout the body, with a great concentration in the gastrointestinal system, here they work to limit unnecessary immune responses. This does not mean that cannabinoids suppress the immune system, it means they allow the immune system to function better, recognizing when immune defense is actually needed and when it is not.

Diseases like IBD and Crone’s are situations in which the immune system in the gut is not working correctly and attacks the body as a foreign body or malicious entity. Those suffering with this disease experience gastrointestinal discomfort and food sensitivities. It is not known exactly what causes this immune system malfunction, but current research indicates it might have a connection with the endocannabinoid system. This would make sense because of the endocannabinoid system’s great influence on the immune system.

The Research

In a study done in 2011, a number of patients with IBD that was resistant to treatment showed marked improvement in symptoms following an introduction of CBD oil into their daily regimen. It is unclear whether or not this was merely based on cannabinoids helping with the symptoms or the underlying issue causing them. However, this is promising to those who experience frustration without relief of their disease.

The most significant improvement seen is in the quality of life. For those with chronic illness, living a normal life with the disease is the hardest part. With limited options for treatment of these inflammatory conditions, CBD offers a viable option for relief. With legalization of cannabinoids from hemp and medical marijuana, more and more patients are turning to alternative treatments.

Crone’s disease is an autoimmune disease that is characterized by inflammation of the digestive tract. Those with this disease often suffer gastrointestinal discomfort and pain. Food sensitivities accompany this illness and often lead to extreme weight loss. In a study that compared the use of CBD to a placebo, the group that consumed cannabis showed more improvement in their symptoms. It is important to note that these results are in comparison to a placebo treatment. However, when considering the alternative medications to Crone’s and their side effects CBD might be a more appealing option.
In many cases, steroids are used to treat chronic inflammation, and when used long term they can cause diabetes, high blood pressure, and higher risks of infection.

While there is limited evidence that shows the validity of actual treatment of diseases using cannabinoids, the improvement in symptoms is enough to give hope. As with any medical decision, be sure to consult with your doctor if you are considering adding CBD to your diet. Consider any other medications you are taking as some are metabolized in a way that is not compatible with CBD.

For any questions or to try CBD out for yourself feel free to call us here at Revexia: (970) 449-1603, or stop by our storefront located at 1724 Topaz Drive, Loveland, CO 80537.

The Endocannabinoid Deficiency Theory Explained

The Endocannabinoid Deficiency Theory Explained

Endocannabinoid Deficiency Theory

In our previous post, we touched on the endocannabinoid system and how this neurological network works within our bodies to maintain systematic homeostasis. Cannabinoids work with CB1 and CB2 receptors to aid in regulatory functions concerning inflammation, immune response, metabolic performance, as well as a host of other operations within the human body. As an expansion on this topic, it is important to discuss endocannabinoid deficiency theory in relation to the many health claims that are tied to cannabinoids and CBD use. As always, first and foremost, any health related decisions should be discussed with a doctor, especially if you are being treated with medication for any condition. There are certain enzymes within the body that render CBD incompatible for use with certain prescription medication.

We here at Revexia do the digging in order to have the knowledge to offer insight into questions you might have regarding if CBD is right for you.

What is clinical endocannabinoid deficiency?

Clinical endocannabinoid deficiency theory is a new horizon in CBD research; it might hold the key to unanswered conditions such as autoimmune disease, fibromyalgia, and other widespread systematic disorders.

This theory was first introduced in 2001 and highlights the neurological function, or dysfunction of the cannabinoid receptors in the body. The belief is that a lack of endocannabinoid production in the body, or ineffective receptors contribute to an imbalance in the body. This leads to an ineffective or over reactive immune system, or hyperactive inflammatory response. Current studies examine the function of endocannabinoids in patients with conditions like irritable bowel syndrome and migraines, as well as psychological conditions like anxiety and post-traumatic stress disorder. From the limited studies that have been conducted, there is an indication that introduction of a CBD regimen could be helpful in these cases.

Why does this matter?

Because research has seen so many different health conditions responding favorably to CBD treatment, medical professionals hypothesize that endocannabinoid deficiency could be the underlying commonality. Cannabinoids are unique in that they do not treat diseases themselves; rather they activate regulatory systems in the body that might not be working the way they should. The hypothesis is that these hard to treat diseases could all be a product of some kind of deficiency, merely manifesting itself in different ways.

Neurotransmitter deficiencies are cited as the cause for many diseases such as Parkinson’s, Alzheimer’s, and depression. Science has identified the presence of a chemical imbalance in these conditions, marked by a either a lack of chemicals or hormones, or a failure of the receptors that utilize them.

Because the endocannabinoid system works in areas like inflammation, immunity, and cell function, it naturally fits the attributes of autoimmune diseases. Endocannabinoid deficiency could have the ability to explain the pathology behind functional disorders.  In a study published in 2004 by Neuroendocrinology Letters, endocannabinoid deficiency theory is considered provable, but requires extensive research.

It is already apparent through the few studies that have been done so far that cannabinoids have some kind of impact on many systems in the body. Many have claimed overwhelmingly positive results from CBD use. The discovery of the endocannabinoid system itself was impactful in understanding systematic function. However, what remains to be researched and uncovered is if endocannabinoid deficiency theory can be substantiated as an explanation for so many unexplained disorders.

It is clear however, that this is an avenue that should be explored further, for the sake of so many who face diseases that cannot be solved by current traditional medicine.

 

If you are interested in trying CBD or just want more information about the endocannabinoid system, feel free to call Revexia anytime at (970) 449-1603, or stop by our storefront at 1724 Topaz Dr. in Loveland.