Menu

ISTOCK, LPETTET

FDA Approves First Marijuana-Derived Drug

As the CBD-based medication enters the market, the agency promises a crackdown on producers of cannabidiol products that make unproven claims.

Jun 25, 2018
Shawna Williams

The US Food and Drug Administration today (June 25) approved for the first time a marijuana-derived drug, Epidiolex, for the treatment of two rare forms of epilepsy. The drug contains cannabidiol, or CBD, and does not make users high while reducing the rate of seizures in patients with Dravet or Lennox-Gastaut syndromes, clinical trials show.

“In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD,” says Orrin Devinsky of NYU Langone Health, a lead investigator in the trials, in a statement released by the company that makes Epidiolex. “I am delighted that my physician colleagues and I will now have the option of a prescription cannabidiol that has undergone the rigor of controlled trials and been approved by the FDA to treat both children and adults.”

See “Medical Marijuana for Kids?

Both Dravet and Lennox-Gastaut are relatively severe forms of epilepsy that can be fatal, STAT News notes. While there are other drugs approved to treat Lennox-Gastaut, there had previously been none for Dravet. Some parents have used unapproved CBD oils to treat their children. In a statement released today, FDA notes that it “has taken recent actions against companies distributing unapproved CBD products. . . . We’ll continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims.” 

“I'm really happy we have a product that will be much cleaner and one that I know what it is,” Ellaine Wirrell, director of the Mayo Clinic's program for childhood epilepsy, tells the AP. “In the artisanal products there's often a huge variation in doses from bottle to bottle depending on where you get it.” 

See “Opinion: Do Not Believe the Hype

But Heather Jackson of Realm of Caring, a charity affiliated with the CBD company CW Hemp, tells the outlet, “I don't know a mom or dad in their right mind who is going to change what's already working. . . . I really don't think [the FDA approval is] going to affect us much.”

July 2019

On Target

Researchers strive to make individualized medicine a reality

Marketplace

Sponsored Product Updates

Overcoming the Efficiency Challenge in Clinical NGS
Overcoming the Efficiency Challenge in Clinical NGS
Download this white paper to see how an ECS lab serving a network of more than 10,000 healthcare providers integrated QIAGEN Clinical Insight (QCI) Interpret to significantly reduce manual variant curation efforts and increase workflow efficiency by 80%!
Veravas Launches Product Portfolio to Mitigate Biotin Interference and Improve Diagnostic Assay Accuracy
Veravas Launches Product Portfolio to Mitigate Biotin Interference and Improve Diagnostic Assay Accuracy
Veravas, Inc., an emerging diagnostic company, launched a portfolio of products that can improve the accuracy of current diagnostic test results by helping laboratory professionals detect and manage biotin interference in patient samples with VeraTest Biotin and VeraPrep Biotin.
New Data on Circulating Tumor DNA as a Biomarker for Detecting Cancer Progression Presented at 2019 ASCO Annual Meeting
New Data on Circulating Tumor DNA as a Biomarker for Detecting Cancer Progression Presented at 2019 ASCO Annual Meeting
Scientists presented more than 30 abstracts featuring Bio-Rad’s Droplet Digital PCR (ddPCR) technology at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 31–June 4.
BellBrook Labs Receives NIH Grant for the Discovery of cGAS Inhibitors to Treat Autoimmune Diseases
BellBrook Labs Receives NIH Grant for the Discovery of cGAS Inhibitors to Treat Autoimmune Diseases
The National Institute Of Allergy And Infectious Disease recently awarded BellBrook Labs a $300,000 Small Business Innovative Research (SBIR) grant to develop novel inhibitors for the target cyclic GAMP Synthase (cGAS). The grant will be used to accelerate the discovery of new treatments for autoimmune diseases by targeting the cGAS-STING pathway.