The U.S. Food and Drug Administration (FDA) has expanded the age range for all Epidiolex (cannabidiol) indications to include patients ages 1 and older, according to its developer, GW Pharmaceuticals (GW).
The FDA now has also approved Epidiolex to treat seizures associated with tuberous sclerosis complex, a rare genetic disease in which benign tumors can cause epilepsy.
“This label expansion, including the expansion of the age range in all approved indications, further demonstrates that the FDA process can continue to enable broader patient access to appropriately tested regulatory approved cannabinoid medicines,” Justin Gover, CEO at GW, said in a press release.
“It also provides hope for these patients and their families and is yet another important milestone for EPIDIOLEX as a first-in-class antiepileptic drug,” he said.
Epidiolex is a plant-derived cannabidiol (CBD), the most abundant non-psychoactive cannabinoid compound in the cannabis plant. CBD can mimic natural compounds that act on brain receptors, which can cause seizures if they are faulty.
Importantly, CBD does not have the mind-altering effects that are characteristic of delta (9)-tetrahydrocannabinol (THC), the main psychoactive component of marijuana that gets people “high.”
The clinical program for Epidiolex, which led to its approval, included three randomized, controlled Phase 3 clinical trials (NCT02091375, NCT02224703, and NCT02224560) and the GWPCARE5 open-label extension study (NCT02224573).
The cannabidiol was found to be efficient and have an acceptable safety profile as add-on anti-epileptic treatment in people with Dravet — at a dose of 20 mg/kg/d — and in patients with LGS at doses of 10 and 20 mg/kg/d.
Importantly, a lower (10 mg/kg/d) Epidiolex dose was found to have a better safety and tolerability profile among Dravet patients when compared with the higher 20 mg/kg/d dose. Similar clinically relevant reductions in the frequency of convulsive seizures were found at both doses.
The U.S. Drug Enforcement Administration (DEA) recently reclassified Epidiolex as a non-controlled substance, a move that will facilitate Dravet syndrome patients’ access to the treatment. This action removed all federal controlled-substance restrictions for the cannabidiol.
In the U.S., Epidiolex is marketed by GW’s subsidiary, Greenwich Biosciences.
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