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.”

February 2019

Big Storms Brewing

Can forests weather more major hurricanes?

Marketplace

Sponsored Product Updates

Bio-Rad Releases First FDA-Cleared Digital PCR System and Test for Monitoring Chronic Myeloid Leukemia Treatment Response
Bio-Rad Releases First FDA-Cleared Digital PCR System and Test for Monitoring Chronic Myeloid Leukemia Treatment Response
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that its QXDx AutoDG ddPCR System, which uses Bio-Rad’s Droplet Digital PCR technology, and the QXDx BCR-ABL %IS Kit are the industry’s first digital PCR products to receive U.S. Food and Drug Administration (FDA) clearance. Used together, Bio-Rad’s system and kit can precisely and reproducibly monitor molecular response to treatment in patients with chronic myeloid leukemia (CML).
Bio-Rad Showcases New Automation Features of its ZE5 Cell Analyzer at SLAS 2019
Bio-Rad Showcases New Automation Features of its ZE5 Cell Analyzer at SLAS 2019
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) today showcases new automation features of its ZE5 Cell Analyzer during the Society for Laboratory Automation and Screening 2019 International Conference and Exhibition (SLAS) in Washington, D.C., February 2–6. These capabilities enable the ZE5 to be used for high-throughput flow cytometry in biomarker discovery and phenotypic screening.
Andrew Alliance and Sartorius Collaborate to Provide Software-Connected Pipettes for Life Science Research
Andrew Alliance and Sartorius Collaborate to Provide Software-Connected Pipettes for Life Science Research
Researchers to benefit from an innovative software-connected pipetting system, bringing improved reproducibility and traceability of experiments to life-science laboratories.
Corning Life Sciences to Feature 3D Cell Culture Technologies at SLAS 2019
Corning Life Sciences to Feature 3D Cell Culture Technologies at SLAS 2019
Corning Incorporated (NYSE: GLW) will showcase advanced 3D cell culture technologies and workflow solutions for spheroids, organoids, tissue models, and applications including ADME/toxicology at the Society for Laboratory Automation and Screening (SLAS) conference, Feb. 2-6 in Washington, D.C.