The U.S. Food and Drug Administration (FDA) approved Epidiolex in June 2018, a CBD oral solution for the treatment of seizures. The drug is proven to effectively treat two rare forms of epilepsy, Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (D.S.). Epidiolex manufactured by G.W. Pharmaceuticals is approved for children over two years and adults who suffer from one of these rare disorders.
Diagnosed with Dravet Syndrome, Charlotte Figi was the first American girl who took cannabidiol to prevent seizures. Using whole cannabis plant CBD oil extract, Charlotte, who was then five, went from having a seizure every 30 minutes to not having one for a week after starting the treatment. This led to naming the oil “Charlotte’s Web.”
CBD has received great scientific interest due to its
- anticonvulsant,
- antidepressant,
- antioxidant,
- analgesic,
- appetite stimulant,
- muscle relaxant,
- cognitive, and
- neuroprotective properties.
The neuroprotective ability is linked to its antioxidant and anti-inflammatory properties.
What Are Seizures?
Seizures are caused by erratic electrical activity in the brain that can cause uncontrolled physical movements and/or alterations of consciousness. Seizures occur when a part of the brain experiences increased excitation or decreased nerve cell inhibition, causing them to fire abnormally. Underlying conditions may include epilepsy, electrolyte imbalances, Traumatic Brain Injury, sleep deprivation, brain infections, and drug overdose.
What is Epilepsy?
Epilepsy is a complex medical, economic and social issue that affects at least 5.1 million of the U.S. population alone and about 50 million people worldwide. It is the most common neurological disorder characterized by repeated seizures due to an abnormal excessive or synchronous neuronal activity in the brain. About 30% of patients are affected by treatment-resistant epilepsy (TRE), hence do not respond well to antiepileptic therapies.
What is LGS and Dravet Syndrome?
LGS and Dravet syndrome are two rare forms of childhood epilepsy that are usually resistant to antiepileptic drugs. They require two or more anti-seizure drugs to be under control. Dravet syndrome is a debilitating type of frequent febrile seizures, including myoclonic seizures. Children with Dravet Syndrome experience hyperactivity, poor development of language and motor skills, and difficulty relating to others.
LGS begins in early childhood, characterized by frequent seizures, usually between ages 3-5. Most affected children experience tonic seizures, which cause the muscles to contract uncontrollably. Children with LGS develop intellectual disability and learning problems, delayed development of motor skills such as sitting and crawling.
The Endocannabinoid System (ECS) in Epilepsy:
The ECSmaintains homeostasis in the body, and cannabinoid interacts with the CB1 and CB2 receptors in the brain enhancing the work done by the ECS. Cannabinoid receptors are particularly dense in the CNS (central nervous system), in the hippocampus, the part of the brain that handles emotions and memory encoding.
Abnormal changes in the hippocampal cells create an excitatory feedback loop that causes seizures. Studies on animals and humans show that cannabinoids have a neuroprotective effect on hippocampal cells and make the abnormal cells less active. CBD’s anti-seizure effects involve reducing excitability by acting on two groups of receptors, namely GPR55 and TRPV1 receptors.
Recent research on animal models and human clinical observations also indicates cannabinoids decrease glutamate synthesis throughout the CNS, decreasing inflammation and seizure activity.
The Role of CBD And Other Phyto-cannabinoids In Controlling Seizures:
A review in the Journal of Clinical Neurophysiology noted that CBD, either as an isolate or part of a CBD-enriched plant extract, decreases the frequency of seizures in treatment-resistant epilepsy.
Evidence suggests that CBD in the whole-plant extract is four times more effective than isolated CBD. This may probably be due to the ‘entourage effect, whereby the whole plant’s therapeutic effect is more significant than a single compound.
This was confirmed through a study in which 71% of people using CBD-rich extracts had reduced seizure frequency compared with 46% of those using CBD isolates. The population was treatment-resistant, having tried 4-12 medications before using CBD.
Epidiolex and Epilepsy
FDA-approved CBD isolate Epidiolex is used to treat seizures and rare forms of epilepsy, such as D.S. and LGS. The drug’s uniform strength and consistent delivery give a person that they are getting the exact dose. Epidiolex contains 98% purified CBD, hence it is a better than other forms of CBD available.
Dosing: Clinical trials done on Epidiolex tested a range of 2-50mg/kg/day. While dosing, an experienced physician recorded an EEG before starting CBD oil and repeated the same at 1-3 months to see if the child showed improvement.
Oral or sublingual dosing of a lab-tested, quality-controlled CBD oil with a ratio of at least 10:1, CBD: THC is started at 1mg/kg/day. These doses are divided into 8-hour doses and increased every 1-2 weeks depending upon the child’s results. The therapeutic range for most patients seems to be 5-10mg/kg/day. The recommended starting dose is usually 2.5mg/kg twice a day which can be increased to 5mg/kg twice a day.
CBD is an astonishingly safe drug and a recent study published confirms that high doses of CBD (1500mg/day) can be used safely with antiepileptic drugs. CBD can be used as a first-line treatment for epilepsy and can enhance other antiepileptic drugs. However, it may interact with other drugs and cause some side effects. Sleepiness, drowsiness, diarrhea, and loss of appetite are some side effects associated with prolonged use of CBD.
CBD For Other Kinds of Seizures:
Tuberous sclerosis complex is a rare genetic disorder that is characterized by noncancerous tumors to grow in various parts of the body. Tumor growth in the brain may cause seizures; 25-50 mg/kg of Epidiolex proved effective.
The effect of CBD on 55 people with one of the following epileptic syndromes:
Aicardi syndrome, CDKL5 deficiency syndrome, Doose syndrome, and Dup15q syndrome was examined in a 2018 study. The participants had an average of 59.4 seizures/month. After 12 weeks of medication, the average went down to 22.5/month.
A note of caution while using commercial CBD products to treat epilepsy uses a high-quality product made from organically grown hemp, properly labeled and clearly states the amount of CBD in the product is recommended.
A 2020 study found that the group taking prescription CBD, i.e., Epidiolex, showed a 39% reduction in seizures. Since Epidiolex is FDA approved, it has a consistent dose with high manufacturing standards.
Epidiolex is a prescription drug approved by the FDA to cure treatment-resistant epilepsy in children. CBD is effective for treating other types of seizures too. The dosage and frequency of CBD will depend on the product being used and the severity of the condition. The ECS plays an important role in enhancing the effect of cannabinoids in the body.