Cannabis-Derived Drug Approved by FDA for Epilepsy Treatment

On Monday, the Food and Drug Administration approved the first cannabis-based prescription drug. Utilizing cannabidiol (CBD), a component of cannabis that does not induce euphoria, the new drug Epidiolex has been approved as a safe and non-psychoactive treatment for rare forms of epilepsy.  

The drug is only approved for treatment of Lennox-Gestaut and Dravet syndromes. Both are very uncommon epileptic conditions, with roughly 0.1 to 0.28 adults per every 100,000 having Lennox-Gestaut syndrome, and 6.37 per every 100,000 having Dravet syndrome. Lennox-Gestaut syndrome is much more common in children, however, with the annual incidence being 2 children per every 100,000.  

Today FDA approved the first drug with a compound derived from marijuana for treatment of seizures associated with certain rare, severe forms of epilepsy https://t.co/jXpMijNQKu pic.twitter.com/51i97XTm7l

— U.S. FDA (@US_FDA) June 25, 2018

Epidiolex is the first drug to be approved specifically for Dravet syndrome treatment, and according to FDA’s Dr. Billy Dunn it will “provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.” Dravet syndrome usually presents in the form of fever-linked seizures during infancy, evolving into more severe seizures-types later in life. This typically induces hyperactivity, various social complications, and hinders language and motor skill development. 

Lennox-Gestaut syndrome usually presents seizures later in childhood, beginning around ages 3 to 5. This form of epilepsy is almost always coupled with intellectual complications and difficulty learning. Motor skill development is often impaired in those with Lennox-Gestaut syndrome as well, requiring most to have assistance with routine daily activities.   

FDA commissioner Dr. Scott Gottlieb stresses that this is not an approval of all cannabis-based medications- it is one specific CBD medication extracted from CBD flower being approved by marketing companies for CBD for the treatment of two forms of epilepsy. The FDA warns the public to be weary of unproven claims from companies selling cannabis-derived treatments, and states that valid scientific studies displaying safety and effectiveness are prerequisites for consideration of approval.  

“The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases,” – Dr. Scott Gottlieb 

Sources: NBC News, Dravet Foundation, National Organization for Rare Disorders