Officials with the FDA have approved cannabidiol oral solution (Epidiolex) for the treatment of seizures associated with 2 rare and severe forms of epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome, in patients aged 2 years and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana, and is the first FDA approval of a drug for the treatment of patients with Dravet syndrome.
Officials with the FDA have approved a novel cannabidiol (CBD) treatment for 2 rare and severe forms of epilepsy, making it the first FDA-approved medication that contains a purified drug substance derived from marijuana, according to a press release.1 Epidiolex (GW Research) is an oral solution indicated to treat seizures associated with Lennox-Gastaut syndrome (LGS), and Dravet syndrome in patients aged 2 years and older.
The first in a new category of antiepileptic drugs (AEDs), Epidiolex is a prescription formulation of highly-purified, plant-derived CBD, a cannabinoid lacking the high associated with marijuana. This is the first FDA approval of a drug to treat Dravet syndrome.
The approval is based on efficacy data from 3 clinical trials involving 516 patients with either LGS or Dravet syndrome. In the trials, epidiolex, taken along with other antiepileptic medications, reduced the frequency of seizures compared with a placebo. The most common adverse reactions were somnolence, decreased appetite, diarrhea, transaminase elevations, fatigue, malaise, rash, insomnia, sleep disorder and poor quality of sleep, and infections.
“In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD,” Orrin Devinsky, MD, of NYU Langone Health’s Comprehensive Epilepsy Center and a lead investigator in the epidiolex clinical program, said in a GW Pharmaceuticals press release.2 “I am delighted that my physician colleagues and I will now have the option of a prescription cannabidiol that has undergone the rigor of controlled trials and been approved by the FDA to treat both children and adults.”
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