The Food and Drug Administration (FDA) finally approved the first prescription drug derived from cannabidiol (CBD), a milestone that researchers are hoping will open the door to more of the same…and a relief for families and relatives of children with intractable epilepsy.
The medication, Epidolex, has been shown effective in significantly reducing seizures caused by two rare forms of epilepsy that begin in childhood: Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS).
Developed by GW Pharmaceuticals, based in England, Epidiolex is essentially a pharmaceutical-grade CBD oil, already used by some parents to treat children with epilepsy. CBD is one of more than 100 chemicals found in cannabis.
After having done research on more than 500 children and adults and navigating the legal hurdles that continue to line the path of cannabis research, GW’s strawberry-flavored syrup has been approved.
Physicians say it’s important to have a consistent, government-regulated version.
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA Commissioner Scott Gottlieb said in a statement, reported by AP. “And, the FDA is committed to this kind of careful scientific research and drug development.”
Physicians are chiming in.
“I’m really happy we have a product that will be much cleaner and one that I know what it is,” said Dr. Ellaine Wirrell, director of the Mayo Clinic’s program for childhood epilepsy. “In the artisanal products there’s often a huge variation in doses from bottle to bottle depending on where you get it.”
Before GW can market Epidiolex, however, the Drug Enforcement Administration (DEA) will have to reclassify CBD, which it still considers a Schedule I drug. The DEA is expected to do that within 90 days.
The question is: will the DEA reclassify CBD and leave cannabis itself on the Schedule I list?