Epidiolex: Cannabidiol Prescription Medicine
One of the biggest obstacles for prescribing cannabis as a medicine is the schedule 1 status that the DEA (Drug Enforcement Agency) has placed upon it.
With that being said, any state where cannabis is outlawed as a whole would benefit tremendously if a prescription medicine containing cannabidiol (The naturally forming cannabinoid within cannabis that does not produce psychoactive effects) were to be reclassified as a lower schedule.
Fortunately, this is exactly what has been done through Epidiolex. Families no longer have to be uprooted to unfamiliar cities with uncertain outcomes because the law won’t allow them to take care of their loved ones. Although the 2018 rescheduling of Epidiolex is a major win for proponents of cannabis, there are still much more obstacles to be hurdled and progress to be made.
What Is Epidiolex?
Epidiolex is a prescription grade medicine produced by the British GW Pharmaceuticals company, containing cannabidiol as the main active ingredient.
It also includes non-active ingredients such as strawberry flavoring, dehydrated alcohol (also known as anhydrous ethanol or absolute ethyl alcohol), sesame seed oil, sucralose (zero-calorie artificial sweetener) and contains zero gluten.
Epidiolex is an oral solution that is made up of extract solely from the cannabis plant, making it purely plant derived. Most importantly, it is approved for use on patients from ages 2 and up, meaning many young and suffering patients can legally and easily access life-saving medicine.
FDA Approves Epidiolex As Treatment For Seizures
Back in September 2018, by joint decision of the DEA and DOJ (United States Department of Justice), the oral solution of Epidiolex was rescheduled to the lowest possible classification of schedule 5.
Schedule 5 is described as drugs, substances or chemicals that have a low potential for abuse, generally reserved for antidiarrheal, antitussive and analgesic medicines.
This puts Epidiolex among the likes of cough medicine (Less than 200mg of codeine) such as Robitussin AC and diarrhea management medications.
Two months before this historic reclassification, the FDA (United States Food and Drug Administration) approved Epidiolex as the first ever FDA-approved drug to treat Dravet Syndrome, which is a severe form of epilepsy that develops during childhood.
However, although Epidiolex is the spearhead for FDA-approved cannabidiol prescription medicines, it has only paved the way for cheaper and more effective medicines just like itself.
Epidiolex Stock Surges After FDA Approval
On Wednesday, September 19, 2018, the NASDAQ (A broad-based stock index) stock named GWPH for GW Pharmaceuticals was soaring sky high as the DOJ and DEA were planning to reschedule Epidiolex from schedule 1 to 5.
During the entirety of the trading day, the stock was constantly on the rise, while also increasing the stock’s trading volume by nearly 5 times its daily average just as the report came in from David Lebowitz of Morgan Stanley.
In the report, David Lebowitz claimed that the DEA planned to reclassify Epidiolex for medicinal use which came two months after the historic FDA ruling.
This spike in the stock is largely due to the potential profits that many investors expect GW Pharmaceuticals to produce in the coming months or years due to their creation of the sole cannabidiol medicine that is legal across all pharmacies and borders in the United States.
Clinical Trials On Epidiolex
Cannabidiol research can be traced back to scientists conducting trials in 2007 when cannabidiol had yet to hit the mainstream.
The most recent trials among researchers have shown that Epidiolex, when used with other anti-epileptic or anti-seizure medication effectively reduced the overall frequency in seizures in comparison to placebo trials.
The clinical trials of Epidiolex included three random, placebo-controlled, double-blind studies that involved an astounding 516 patients that suffered from either Dravet syndrome or Lennox-Gastaut syndrome.
In a May 2017 issue of The New England Journal of Medicine, it was stated that a 50 percent reduction in convulsive seizures was experienced in 43 percent of children with Dravet syndrome while 5 percent saw a complete disappearance of seizures altogether.
In other studies presented during the Annual Meeting of the American Academy of Neurology, it was reported that when cannabidiol was added to any anti-epileptic or anti-seizure therapy drug, it significantly reduced the frequency in which drop seizures occurred in patients with Lennox-Gastaut Syndrome that were treatment-resistant (which means existing treatments did not adequately improve their conditions).
Drop seizures being more common in children which involve a sudden loss of muscle tone causing the affected child’s body to go limp and fall down.
Lastly, another published study by The New England Journal of Medicine in May 2018 concluded that both adults and children who suffered from Lennox-Gastaut syndrome experienced the greatest reductions in seizure frequency when 10 to 20 milligrams of cannabidiol per kilogram of body weight was implemented in tandem with a regularly prescribed anti-epileptic medication.
What Is Epidiolex Used For?
Epidiolex is a prescription medicine that contains cannabidiol as its main active ingredient. It is used to treat patients 2 years and older who suffer from severe epileptic conditions such as Lennox-Gastaut Syndrome and Dravet syndrome.
Epidiolex’s main contribution to seizure-prone patients is the tremendous reduction in seizures it can cause and possibly even completely eliminating seizures for some patients as well.
How To Use Epidiolex
Epidiolex is an oral solution that can be administered directly into the patients’ mouth and swallowed. This is made easy with the provided oral syringe that is provided with each bottle of Epidiolex upon purchase.
Epidiolex Preparation And Administration
In order to be prepared for Epidiolex as a prescribed medication, it is suggested by the manufacturer that:
- Use EPIDIOLEX within 12 weeks of first opening the bottle
- After 12 weeks, safely throw away any EPIDIOLEX that has not been used
- Do not use EPIDIOLEX after the expiration date on the package and each bottle
- Ask your healthcare provider or pharmacist if you are not sure how to prepare, take, or give the prescribed dose of EPIDIOLEX
- Be sure that you read, understand, and follow the Instructions for Use carefully to ensure proper dosing of EPIDIOLEX
- Follow your healthcare provider’s instructions for the dose of EPIDIOLEX to take or give the prescribed dose of EPIDIOLEX
- Always use the oral syringe provided with EPIDIOLEX to make sure you measure the right amount of EPIDIOLEX
The dosage for Epidiolex is generally decided by a patient’s body weight. The general recommended starting dose for patients is 2.5 milligrams per kilogram, twice a day. Following a week of use, the dose is usually increased to 5 milligrams per kilogram, twice a day which is considered maintenance.
If a patient requires an increased reduction of seizures the patient can take anywhere from 10 milligrams per kilogram to 20 milligrams per kilogram, twice a day. However, it has been noted that such an increase in usage could result in unwanted side effects due to some ingredients contained within Epidiolex.
Although there are no direct warnings that come with the use of Epidiolex, patients should be monitored for any hypersensitivity to ingredients such as cannabidiol within Epidiolex.
It is recommended that users should avoid eating meals that are high in calories and fat as an increase in weight will mean a required increase in dosage and a possible increase in the body’s drug absorption abilities. It should also be noted that no trials have been conducted which included women who are pregnant.
Epidiolex Side Effects
The possible and common side effects reported during clinical trials included:
- Elevated liver enzymes
- Sedation and lethargy
- Sleep disorder and poor quality sleep
- Decreased appetite
- Malaise and weakness
Possible symptoms of traditional epilepsy medication may occur with the addition of Epidiolex such as:
- New or worsening depression
- Panic attacks
- Attempts to commit suicide
- Feelings of agitation
- Thinking about suicide
During clinical trials, Epidiolex resulted in liver damage that was mild, but may result in the following:
- Dark urine
- Abdominal pain
The Benefits Of Using Epidiolex
Epidiolex is easily accessible to patients around the United States due to its approval by the FDA and reclassification by the DEA and DOJ.
Patients who use Epidiolex in tandem with a traditional anti-epileptic or anti-seizure medication can expect to experience a tremendous decrease in seizure frequency and a possible complete disappearance of seizures.