FDA approves first drug derived from cannabis
The Food and Drug Administration (FDA) approved the first drug derived from cannabis to treat rare, severe forms of epilepsy, according to a press release published by the agency on June 25.
The drug, Epidiolex, or cannabidiol (CBD), is a treatment for seizures associated with two forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. It is the first FDA approval of a drug derived from cannabis, as well as the first drug for treatment of patients with Dravet syndrome, according to the FDA.
CBD is a chemical component of the cannabis sativa plant, and is one of more than 80 active cannabinoid chemicals. However, unlike contain tetrahydrocannabinol (THC), the primary psychoactive component of marijuana that can be derived from parts of the cannabis plant, it does not cause intoxication or a “high.”
Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken along with other medications, was shown to be effective in reducing the frequency of seizures when compared with placebo.
In April, an FDA advisory committee unanimously supported approval of the drug before it reached the FDA for a final vote on Monday. The drug is administered in a syrup form and taken orally. Most patients who would take the drug would have uncontrolled daily seizures despite treatment, putting them at high risk for developmental disabilities, serious injury, and premature death, according to the FDA.
This approval could pave the way for other cannabis-based drugs in conventional medicine and is a big step for the FDA, said Scott Gottlieb, MD, FDA Commissioner.
“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,” said Gottlieb. “We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products.”