Legislation and Policy

FDA Approves More Uses for Epidiolex

Colby McCoy
Written by Colby McCoy

As of July 2020, the FDA has approved an additional use for the cannabidiol-derived drug Epidiolex as an oral solution for the treatment of seizures linked to tuberous sclerosis complex (TSC) starting at one years of age or older.

This is a big victory for cannabis’ role in medicine as a viable treatment for a whole host of conditions, including epilepsy, depression, anxiety, and debilitating conditions.

In an official statement, the FDA pointed out that Epidiolex is “… the only FDA-approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with TSC.”

What exactly is TSC?

It is a rare genetic disease that causes non-cancerous tumors to grow in various parts of the body, including the brain, eyes, heat, kidneys, lungs, etc. The disease is known to target the central nervous system, causing seizures and even behavioral problems according to the FDA. It is know to affect roughly 1 in 6,000 people.

Epidiolex was originally approved by the FDA for treating two rare and severe epileptic conditions known as Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS).

The drug’s viability as a treatment for LGS and DS was found in a randomized, double-blind, placebo-controlled study where 124 patients out of a total of 248 were given Epidiolex.

It was found that patients on Epidiolex saw a noticeable decrease in seizure activity over a 16-week treatment period. Researchers noted an improvement in conditions for the 124 patients as early as 8 weeks into the study.

In all, the FDA’s recent approval of a secondary use for Epidiolex points to ongoing research into cannabis as potential medicine and the willingness of the FDA to approve cannabis-derived medical solutions.

While this is indeed a victory, there is still a long way to go on the long, often unpredictable road of cannabis research.

Photo courtesy of Unsplash

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Colby McCoy

Colby McCoy

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