Could a drug for epilepsy alter US Federal Cannabis Policy?

Epidiolex has been given FDA approval to treat seizures in children. The medicine contains a cannabis ingredient, but it is doubtful that its approval will change the law regarding medicinal cannabis.

There will soon be a prescription form of the substance after years of anecdotal reports from parents who used a cannabis derivative to help manage their children’s seizures.

The first medication made from cannabidiol (CBD), one of the several substances contained in the cannabis plant, has been approved by the U.S. Food and Drug Administration (FDA) [1].

Tetrahydrocannabinol (THC), on the other hand, is what gives cannabis its characteristic “high,” but CBD does not.

Lennox-Gastaut syndrome and Dravet syndrome are two uncommon kinds of epilepsy that the medication Epidiolex, an oral solution, has been licensed to treat in patients 2 years of age and older.

The treatment is also the only one now authorised to treat Dravet syndrome, a rare genetic disorder wherein newborns frequently have seizures that may have an impact on their development.

Between 1 and 4% of all occurrences of juvenile epilepsy are thought to be caused by Lennox-Gastaut.

After Epidiolex’s efficacy was examined in 516 individuals with either Lennox-Gastaut syndrome or Dravet syndrome, the drug was authorised.

According to the  FDA, the medicine was found to lower the frequency of seizures when combined with other treatments in three randomised, double-blind, placebo-controlled clinical studies.

Dr. Scott Gottlieb, commissioner of the FDA, stated that “this product approval indicates that furthering good scientific research to examine compounds derived from cannabis may lead to valuable therapeutics. This innovative therapy offers patients fresh alternatives.”

Classifying Cannabis

Although cannabis is legal or decriminalised in more than 30 states, the federal government is adamant about maintaining the plant’s most restrictive classification under the Controlled Substances Act (CSA).

Cannabis is still classified as a Schedule 1 narcotic by the Drug Enforcement Agency (DEA), meaning it has “no generally accepted medicinal use and a significant potential for misuse.” Heroin and LSD are among the other substances on that list.

In order to decide Epidiolex’s scheduling, which would influence the sentencing guidelines for persons who possess it without a doctor’s prescription, the federal government has 90 days from the date of approval.

That includes scientists who wish to learn more about the potential of CBD. According to the FDA’s notice, it will be “prepared to take action” if it discovers that CBD-containing products are being illegally marketed while making significant, unproven medical claims.

Epidiolex, according to Paul Armentano, deputy director of the National Organisation for the Reform of Marijuana Laws (NORML), might be the first of many cannabis-based medications to receive FDA approval.

However, he said in a statement, “These alternatives should not be regulated as possibilities to replace the use and regulation of herbal cannabis – a plant that humans have used safely and successfully as a medicine for thousands of years and is now recognized by legislation in 30 states.

No Change Expected

However, Epidiolex is not the first cannabis-based drug to receive FDA approval. The FDA approved a THC derivative in 1985; it is most frequently prescribed under the trade name Marinol [3]. It helps AIDS patients with their appetite by reducing nausea brought on the cancer treatments.

The Association of Cannabis Specialists’ president and CEO, Dr. Jordan Tishler, a Harvard-educated physician, claims that the federal government’s attitude on cannabis hasn’t changed since the approval of Marinol in the 1980s and doesn’t expect Epidiolex to be any different [4].

The federal government’s stance on cannabis is founded on a myth that was created at the time the CSA was passed (in 1971). Since then, they have blatantly ignored all scientific evidence, Tishler told Healthline. In the next years, the federal government’s position on cannabis may shift, but neither this product nor the FDA itself will be the driving force behind it.

According to Todd Davis, chief executive officer of Endexx Corporation, which creates and sells CBD product lines for both people and animals, the approval of Epidiolex demonstrates that cannabis has legitimate medicinal uses.

As a result, he told Healthline, “the DEA’s reading of the statute is out of date.” In the end, Congress must set the example for how to change legislation and policy in a way that allows the market, research, and education to function as intended.

The FDA’s clearance, according to Eyal Barad, CEO of Cannabics Pharmaceuticals, gives the medical cannabis market legitimacy. Cannabics Pharmaceuticals is a biotech business that employs artificial intelligence to produce CBD-based cancer medicines.

But the federal government must reduce cannabis scheduling status in order to aid in research and development.

According to Barad, there are countless potential applications for cannabis as a medicine. Research has previously shown that there are health advantages of combating cancer in addition to epilepsy. Its advantages will only become more obvious with greater investigation.

A Challenge For Doctors

Another concern is whether medical professionals would be willing to recommend cannabis-based medications to their patients.

Lennox-Gastaut or Dravet syndrome patients will “definitely” be prescribed Epidiolex by Dr. Aaron Cardon of Child Neurology Consultants of Austin since it is “first-in-class,” which means it prevents seizures from occurring differently in the brain than any other medicine on the market.

Cardon told Healthline that such first-in-class medications are “extremely encouraging” since they provide novel combinations for patients whose seizures are not under control and new opportunities for seizure independence.

Doctors are frequently uneducated about cannabis, according to Sanford Wolgel, PhD, a former chief science officer at Chicago-based Cannabistry Labs, and patients must undergo a challenging process of trial-and-error to determine what is best for their bodies.

The “patchwork of regulation” that results from the conflict between federal and state legislation is another issue.

He predicted that “cannabis policy is evolving in the United States and will soon result in legalization on a federal level.” As soon as this occurs, considerably more academic and medical study on CBD and cannabis will be possible.


[1] FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana to Treat Rare, Severe Forms of Epilepsy


[3] FDA-Approved Drugs

[4] Evidence based cannabis association

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