Abstract
Medically refractory epilepsy remains an area of intense clinical and scientific interest since a significant porportion of patients continue to suffer from debilitating seizures despite available therapies. In this setting, recent studies have focused on assessing the benefits of cannabidiol (CBD)-enriched cannabis, a plant based product without psychoactive properties which has been shown to decrease seizure frequency in animal models. More recently, several randomized controlled and open label trials have studied the effects of Epidiolex, a 99% pure oral CBD extract, on patients with refractory epilepsy. This in turn has led to the FDA approval of and more recently, to the Drug Enforcement Administration’s placement of Epidiolex into schedule V of the Controlled Substances Act (CSA). In this review, we summarize the major findings of several recent large-scale studies using this product with a focus on its adverse effects.
Highlights
Refractory epilepsy remains an area of intense clinical and scientific interest since a significant porportion of patients continue to suffer from debilitating seizures despite available therapies
Since up to 35% of patients with refractory epilepsy have inadequate seizure control despite currently available treatments, there has been growing interest in the use of cannabis-derived products for the treatment of medically refractory epilepsy over the past 10 years[1,2]. This need, combined with recent media attention focused on the benefits of non-purified cannabidiol (CBD)-enriched cannabis in the treatment of refractory epilepsy[3], has spurred a series of clinical trials in an attempt to more clearly understand the risks and benefits associated with this treatment
Unlike THC, CBD is non-hedonic with no known abuse potential, lacks detectable psychoactive properties, and has a relatively low affinity for both cannabinoid type 1 receptor (CB1R) and cannabinoid type 2 receptor (CB2R)
Summary
F1000 Faculty Reviews are written by members of the prestigious F1000 Faculty. They are commissioned and are peer reviewed before publication to ensure that the final, published version is comprehensive and accessible. For patients with Lennox–Gastaut syndrome, the addition of Epidiolex to a stable regimen at doses of both 10 mg/kg per day and 20 mg/kg per day resulted in significant median percentage decreases in drop seizures (atonic, tonic, or tonic-clonic) of 41.9% for 20 mg/kg per day and 37.2% for 10 mg/kg per day versus 17% for the placebo group (P = 0.005 and P = 0.002, respectively)[24]. Despite the above interactions with anti-seizure drugs, a recent open-label study showed a statistically and clinically significant decrease in overall side effects reported by patients when Epidiolex was added to their anti-seizure drug regimen This decrease remained stable even after Epidiolex dose was increased and doses of other anti-seizure drugs were decreased[26]. Grant information The author(s) declared that no grants were involved in supporting this work
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