CBD oral solution was FDA-approved for severe childhood epilepsies alongside other emerging antiepileptic drugs | Research

The takeaway

A progress report from the Eilat XIV conference summarized the FDA approval of cannabidiol oral solution for Lennox-Gastaut and Dravet syndromes, alongside data on other investigational antiepileptic compounds.

Read this if you want to understand the FDA approval of CBD for epilepsy and its place in antiepileptic drug development.

First cannabis-derived FDA-approved medication: cannabidiol oral solution for severe epilepsies

What the researchers found

This progress report from the Fourteenth Eilat Conference on New Antiepileptic Drugs documented a landmark regulatory event: on June 25, 2018, the FDA approved a standardized cannabidiol oral solution (Epidiolex) for treating seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients 2 years and older.

The report placed cannabidiol within the broader context of antiepileptic drug development, alongside other compounds in advanced clinical development including cannabidivarin, fenfluramine, ganaxolone, and several others. For cannabidiol specifically, the report noted promising efficacy and safety results from placebo-controlled randomized controlled trials.

The conference highlighted that there continues to be a steady flow of potential antiepileptic drugs progressing to clinical development, many with innovative mechanisms of action. The inclusion of two cannabinoid-derived compounds (cannabidiol and cannabidivarin) among these reflects the growing acceptance of the endocannabinoid system as a legitimate therapeutic target in epilepsy.

Why it matters

The FDA approval of Epidiolex was a watershed moment for cannabinoid medicine, representing the first plant-derived cannabinoid product to receive FDA approval for any condition. Its inclusion in a mainstream conference on antiepileptic drugs signals the integration of cannabinoid research into conventional pharmaceutical development.

The numbers in context

FDA approval: June 25, 2018. Approved for: Lennox-Gastaut syndrome and Dravet syndrome. Age cutoff: patients 2 years and older. Conference attendance: 168 delegates from 28 countries. Other cannabinoid in pipeline: cannabidivarin.

How the study worked

This was a conference progress report summarizing preclinical and clinical data presented at the Eilat XIV conference (Madrid, May 2018) for investigational antiepileptic compounds, attended by 168 delegates from 28 countries.

What this study cannot tell us

This is a conference progress report rather than a systematic review. The data on individual compounds reflects presentations rather than peer-reviewed publications in all cases. The report covers a broad range of compounds with varying evidence levels.

How to read the evidence

This reports on compounds backed by randomized controlled trials and FDA review, representing strong evidence for the approved indication.

When this study was published

Published in 2018, documenting the landmark FDA approval of Epidiolex. The product has been in clinical use since.

The bigger picture

The approval of Epidiolex opened doors for cannabinoid pharmaceutical research beyond epilepsy. It demonstrated that cannabis-derived compounds could meet the rigorous standards of FDA drug development, paving the way for future cannabinoid-based medications. It also influenced the subsequent rescheduling of Epidiolex under the Controlled Substances Act.

Questions still open

Will cannabidivarin prove effective for different epilepsy types than cannabidiol? Can the success of Epidiolex accelerate FDA approval of other cannabinoid-based medications? How does pharmaceutical-grade cannabidiol compare to artisanal cannabis products for epilepsy?

Common questions

Is CBD FDA-approved for epilepsy?

Yes. On June 25, 2018, the FDA approved Epidiolex, a standardized cannabidiol oral solution, for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients 2 years and older. This was the first cannabis-derived product to receive FDA approval.

What makes Epidiolex different from regular CBD?

Epidiolex is a pharmaceutical-grade, standardized formulation that went through the full FDA drug development process including multiple randomized controlled trials. Unlike commercial CBD products, its purity, consistency, and efficacy have been rigorously verified.

Read the original research

Progress report on new antiepileptic drugs: A summary of the Fourteenth Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XIV). II. Drugs in more advanced clinical development.

Epilepsia, 59(10), 1842-1866

View on PubMed ↗Publisher’s paper ↗

Citation

Bialer, Meir; Johannessen, Svein I; Koepp, Matthias J; Levy, René H; Perucca, Emilio; Tomson, Torbjörn; White, H Steve. (2018). Progress report on new antiepileptic drugs: A summary of the Fourteenth Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XIV). II. Drugs in more advanced clinical development.. Epilepsia, 59(10), 1842-1866. https://doi.org/10.1111/epi.14555