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.

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.