In a major milestone for medical marijuana, the U.S. Food and Drug Administration on Monday approved a cannabis-based drug, making it the first marijuana substance meeting the federal agencies stringent guidelines.
The drug, Epidiolex, was developed by GW Pharmaceuticals, a publicly traded British cannabis company. The strawberry-flavored syrup is a purified form of cannabidiol (CBD), a non-psychoactive component in cannabis. The approval is expected to spur additional research into cannabis, which is still illegal under federal law.
The FDA’s ruling clears the way for the drug to be used in patients aged 2 years and older suffering from Dravet Syndrome and Lennox-Gastaut Syndrome, two rare childhood-onset forms of epilepsy that are among the most resistant to treatment.
“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said the FDA’s Dr. Billy Dunn. “In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”
The approval only covers use of the liquid drug for Lennox-Gastaut syndrome and Dravet syndrome. FDA advisers recommended the approval in April.
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Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures. Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others.
Lennox-Gastaut syndrome begins in childhood. It is characterized by multiple types of seizures. People with Lennox-Gastaut syndrome begin having frequent seizures in early childhood, usually between ages 3 and 5. Most people with Lennox-Gastaut syndrome require help with usual activities of daily living.
Under the Controlled Substances Act, CBD is currently a Schedule I substance because it is a chemical component of the cannabis plant.