FDA Approves First Marijuana-Based Drug

The US Food and Drug Administration (FDA) has approved Epidiolex (cannabidiol)[CBD] oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients aged 2 years and older. This is the first drug approved by the FDA that contains a purified drug substance derived from marijuana.

The FDA noted that although CBD is a chemical component of the cannabis sativa plant, it does not cause intoxication or euphoria associated with tetrahydrocannabinol (THC).

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“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 FDA Commissioner Scott Gottlieb, MD.

The effectiveness of the drug was examined in 3 randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. In these studies, Epidiolex was shown to effectively reduce the frequency of seizures compared with placebo.

The most common side effects associated with Epidiolex treatment were sleepiness, sedation, elevated liver enzymes, decreased appetite, diarrhea, rash, fatigue, malaise, insomnia, sleep disorder, and infections.

—Michael Potts

Reference:

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy [press release]. June 25, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm.