FDA Approves Cannabidiol (CBD) for Treatment of Rare Seizure Disorders

FDA Approves Cannabidiol (CBD) for Treatment of Rare Seizure Disorders

The FDA recently approved Epidiolox (Cannabidiol) for the treatment of Dravet syndrome and Lennox-Gastaut syndrome, two rare and severe seizure disorders which are often resistant to standard anti-epileptic drugs.   CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana.  However, CBD does not cause intoxication or euphoria  that comes from tetrahydrocannabinol (THC).

In a double-blind, placebo controlled trial (1) of 120 children with Dravet syndrome, CBD reduced the  median frequency of convulsive seizures per month from 12.4 to 5.9  compared to placebo,  with a decrease from 14.9 to 14.1 (95% confidence interval [CI], -41.1 to -5.4; P=0.01)  Adverse events including diarrhea, vomiting, fatigue and increased liver function tests were more  frequent in the CBD group.  

 In a double-blind, placebo controlled trial (2) of 225 adults and children with Lennox-Gastaut syndrome participants were randomized to 20 mg of CBD, 10 mg of CBD or placebo.  The median percent reduction in seizures was 41.9% in the 20 mg CBD group, 37.2% in the 10 mg  CBD group, and 17.2% in the placebo group, both groups receiving CBD were significantly improved compared to placebo.    Somnolence, decreased appetite, and diarrhea were more common in the CBD group.  

Epidiolex  is a 100mg/mL oral solution and marketed by Greenwich Biosciences.  It is currently listed as a Schedule I agent, however, the FDA recommended re-scheduling when it was approved.   

Additional information about the anti-epileptic medications Carbamazepine, Oxcarbazepine, and Phenobarbital can be found in the Top 300 Pharmacy Drug Cards.  If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to the Top 300 Pharmacy Drug Cards.  If your institution does not provide access, ask your medical librarian about subscribing.

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FDA Approves Cannabidiol

1. Devinsky O, Cross JH, Laux L, et al. Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome. N Engl J Med. 2017 May 25;376(21):2011-2020. doi: 10.1056/NEJMoa1611618.

2. Devinsky O, Patel AD, Cross JH, et al. Effect of Cannabidiol on Drop Seizures in the Lennox-Gastaut Syndrome. N Engl J Med. 2018 May 17;378(20):1888-1897. doi: 10.1056/NEJMoa1714631.

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