FDA Approves First Cannabis-Based Drug For Debilitating Seizures

By Victoria Kim 06/27/18

The DEA must re-classify cannabidiol (CBD) before the medication can be available to patients.

child holding a hemp leaf
FDA Approves First Cannabis-Based Drug For Debilitating Seizures

On Monday, the Food and Drug Administration (FDA) approved Epidiolex, a cannabidiol (CBD) treatment for debilitating epilepsy beginning in children as young as 1 or even younger.

Cannabidiol is a chemical compound (cannabinoid) of the cannabis plant known for its pain-relieving and anti-seizure properties, among others. However, it differs from THC, another cannabinoid, by not producing the “high” that marijuana is known for.

Epidiolex was approved for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, both characterized by frequent and debilitating seizures that severely delay or limit a child’s development.

Lennox-Gastaut syndrome can appear in children as young as 3-5 years old, while Dravet syndrome appears during infancy.

According to STAT News, Epidiolex was shown to reduce the number of seizures by about 40% in patients with either disorder.

“The FDA is committed to this kind of careful scientific research and drug development,” FDA Commissioner Scott Gottlieb said in a statement. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients.”

However, drug maker GW Pharmaceuticals will have to wait until the Drug Enforcement Administration (DEA) decides whether to re-classify cannabidiol before it can be available to patients.

Currently CBD is classified as a Schedule I drug, meaning that, by the federal government’s definition, it has no medical value and a high potential for abuse. STAT News reports that the DEA will make a decision in the next 90 days.

Drugs that mimic the anti-nausea and appetite-inducing properties of THC have long been FDA-approved for treating chemotherapy patients and HIV/AIDS patients.

Over a dozen U.S. states have passed legislation specifically to allow CBD for debilitating epilepsy, many of them to help children.

The FDA’s decision gives hope to families living in non-medical marijuana states who have struggled to legally obtain and use CBD products for these conditions.

Alexis Bortell is one patient who could have benefited from legal CBD in all 50 states.

Bortell made headlines last year for being the 12-year-old girl who sued Attorney General Jeff Sessions for promoting the anti-marijuana policy that made it difficult for her to treat her intractable epilepsy that she’s suffered since she was 7 years old.

Her family ultimately moved from Texas to Colorado—where cannabis is legal for both medical and adult use—so they could legally access CBD medication, which she says has allowed her to be seizure-free for about three years now.

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Victoria is interested in anything that has to do with how mind-altering substances impact society. Find Victoria on LinkedIn or Tumblr