FDA Approves First Cannabis-Derived Drug For Treatment Of Epilepsy

For the first time in its history, the US Food and Drug Administration (FDA) has approved a drug derived from one of the active ingredients in marijuana. The FDA is quick to caution us that they are still prepared to “take action” when marijuana-derived products make unproven medical claims; still, it’s hard not to wonder if this signals a softening stance on marijuana’s medicinal potential. Will we see more marijuana-derived drugs in the near future?

The new drug, Epidiolex, is an oral solution derived from CBD, or cannabidiol, one of the chemical components of the cannabis plant. CBD oil has long been touted as a pain-reliever and anxiety-reducer, and many parents of children with autism claim that using medical marijuana or CBD oil has led to drastic reductions in violent and self-harming behaviors.

Photo: AdobeStock/William Casey
Photo: AdobeStock/William Casey

In 2017, the World Health Organization announced its opinion that CBD should not be treated as a controlled substance, is non-addictive, and is effective in the treatment of seizures and related conditions. But in the United States, CBD is still a Schedule I drug because its derived from the cannabis plant. Schedule I drugs are those the DEA says have a “high potential for abuse,” and cannabis is on the same list as drugs like heroin and LSD.

The cannabis plant contains both CBD and THC (tetrahydrocannabinol), but it’s only THC that has the psychoactive properties that cause the “high” associated with marijuana use. The DEA does not currently distinguish between the two compounds.

Photo: Pixabay/herbalhemp
Photo: Pixabay/herbalhemp

About the drug

Epidiolex is designed to treat seizures for those with Lennox-Gastaut or Dravet syndrome, two serious and rare forms of epilepsy. Both syndromes begin in childhood and involve frequent, severe seizures. Dravet’s syndrome can cause a life-threatening state of continuous seizing, and children with Dravet syndrome generally have challenges with language and motor skills, hyperactivity, and social interaction.

Children with Lennox-Gastaut syndrome will likely develop intellectual disabilities, have delayed motor skills, and need assistance with daily living skills throughout their lives.

In trials, Epidiolex reduced the number of seizures in children with these syndromes, and the drug can be prescribed to children as young as two. The FDA granted the drug priority review, which means the FDA will take action on a drug’s application within six months instead of the standard ten.

Photo: AdobeStock/Christin Lola
Photo: AdobeStock/Christin Lola

What’s next?

With clinical trials for CBD’s effect on the symptoms of autism already underway in the United States, it’s hard not to wonder if Epidiolex will be the first of many eventual cannabis-derived drugs.

The FDA’s Commissioner Scott Gottlieb said in a press release:

“We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products.”

The commissioner was quick to stifle the notion that this signals a green light on cannabis: “…we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims,” he said.

Photo: flickr/pipedreemz1
Photo: flickr/pipedreemz1

The line between fact and fiction is sometimes hard to find when it comes to cannabis and its compounds. Claims are overblown, and anecdotal evidence is packaged as universal truth. But with so many claiming CBD is an untapped resource in the treatment of a variety of conditions, including those that affect people with autism, many are grateful for what appears to be a softening attitude about CBD.

More trials are underway, and many will be waiting to see what benefits are found from tapping in (officially) to the potential of cannabis.

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