The oral solution contains cannabidiol, or CBD, a nonpsychoactive compound that has proved beneficial in reducing the catastrophic, potentially life-threatening seizures that accompany both conditions.
In clinical trials, children with Dravet syndrome who took Epidiolex experienced 39 percent fewer seizures; those with Lennox-Gastaut syndrome saw a 37 percent decrease.
In a statement accompanying Monday’s approval announcement, the FDA hastened to note that it’s not signing off on the safety or medical utility of marijuana in general ― just this one compound and only for this limited use.
“It’s also important to note that this is not an approval of marijuana or all of its components,” said Dr. Scott Gottlieb, the FDA’s commissioner. “This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition.”
He added, “This is how sound medical science is advanced.”
Critically, the drug will be available to patients nationwide, not just in states where cannabis is legal for medical purposes.