On Monday, the US Food and Drug Administration approved a cannabis-derived medication used to treat certain forms of epilepsy. The drug, Epidiolex, is made from cannabidiol (CBD) and contains no THC. This is the first time the FDA has approved a cannabis-based medication.
The FDA approved Epidiolex to treat two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. Lennox-Gastaut syndrome causes multiple types of seizures that begin in early childhood, usually between the ages of 3 and 5. Dravet syndrome causes seizures due to a rare genetic dysfunction of the brain. The medication is approved to be administered to patients 2 and older twice daily as an oral solution.
“Today’s announcement gives individuals with Lennox-Gastaut Syndrome and their families much-needed hope,” said LGS Foundation Executive Director Christina SanInocencio.
Dravet Syndrome Foundation Executive Director Mary Anne Meskis agreed with SanInocencio.
“We are very pleased to see the approval of Epidiolex for Dravet and Lennox-Gastaut syndromes. While each of our disorders are different in terms of etiology, both of our communities suffer from intractable seizures, an increased risk of mortality and many devastating co-morbid conditions that significantly affect quality of life.”
CBD can be found in both hemp and marijuana, and unlike other cannabinoids, like THC, CBD has no psychoactive effects. Cannabis, including CBD, is still considered a Schedule I drug under US law.
In a statement Monday, FDA Commissioner Dr. Scott Gottlieb said, “This is an important medical advance. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery.”
“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,”
Epidiolex was developed by UK-based GW Pharmaceuticals, who also manufacture Sativex, another cannabis-based medication used to treat muscle stiffness and spasms associated with multiple sclerosis.