Epidiolex, the First FDA-Approved Cannabis Medication, Nears Market

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Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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The US Drug Enforcement Administration (DEA) has just rescheduled Epidiolex—the recently-approved, cannabis-derived drug for rare forms of childhood epilepsy—from Schedule I to Schedule V. Schedule 1 drugs are not allowed to be prescribed by doctors due to their high potential for abuse, lack of medical use and limited safety data. Schedule V drugs are those considered to have medical use and carry a low potential for abuse, which means Epidiolex has crossed yet another regulatory hurdle to get to market.

This rescheduling represents a landmark shift in the DEA’s stance towards cannabis in the treatment of medical conditions. Marijuana was classified as a Schedule I drug in 1972. The decision made it exceedingly difficult for researchers to investigate whether cannabis or its components like cannabidiol (CBD), the active ingredient in Epidiolex, had any therapeutic value.

Technically, the DEA didn’t reschedule marijuana but rather, FDA-approved medications containing cannabidiol. But, Epidiolex is our only FDA-approved cannabidiol medication to date. We also have three other cannabinoid-related medications: Marinol, Syndros and Cesamet. The active ingredients in these medications are synthetic cannabinoids.


What is Epidiolex for?

Epidiolex is made by GW Pharmaceuticals and is approved by the FDA to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. The medication contains a pharmaceutical grade CBD oil, which is used to treat many patients with epilepsy, but it doesn’t contain tetrahydrocannabinol (THC), the ingredient in marijuana known to produce the mind-altering effects.

GW Pharmaceuticals has not yet discussed how much Epidiolex will cost, but some have speculated that it could cost as much as $25,000 per year. With the new schedule V classification in place, GW Pharmaceuticals plans to launch Epidiolex in six weeks.

What is a cannabidiol (CBD)?

Cannabidiol (CBD) is a non-psychoactive cannabinoid which may have anti-inflammatory, analgesic and antipsychotic properties. It may help with spasticity, epilepsy, and nausea but does not appear to induce euphoria.

Epidiolex would be the first prescription medication in the United States made from the cannabis plant and the first medication in a new category of anti-seizure drugs.


What is Lennox-Gastaut syndrome?

Lennox-Gastaut syndrome (LGS) is an epilepsy syndrome that appears in infancy or childhood and is characterized by seizures (various types), regression and/or cognitive dysfunction, and abnormal EED (electroencephalography) findings. EEGs record the electrical activity of the brain and can be helpful in seeing how seizures progress.


What is Dravet syndrome?

Dravet syndrome, previously known as severe myoclonic epilepsy of infancy (SMEI), is a rare genetic disease characterized by seizures that are often triggered by hot temperatures or fever. Symptoms often appear in the first year of life in otherwise healthy infants and last throughout life. Along with seizures, patients with Dravet syndrome may also have delayed language learning, difficulty with motor control, growth and nutritional issues, and chronic infections.

Does Epidiolex have any known adverse effects?

In pre-market studies, the most common adverse effects of Epidiolex were drowsiness, decreased appetite, diarrhea, elevated liver enzymes, fatigue, rash, sleep disturbances and infections.


Does GW Pharmaceuticals have any other cannabinoid products?

Yes. GW Pharmaceuticals developed the world’s first cannabinoid prescription drug, Sativex, which is approved for the treatment of spasticity due to multiple sclerosis in numerous countries outside the United States. GW Pharmaceuticals also has other cannabinoid products in their pipeline which include compounds in development for epilepsy, glioma and schizophrenia.

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