A new drug derived from marijuana just became the first of its kind to get the green light from the USA government.
Made by the British biopharma company GW Pharmaceuticals, Epidiolex uses purified cannabidiol, or CBD, which is one of more than 80 active compounds in the cannabis sativa plant, often known simply as marijuana.
Epidiolex contains CBD, which does not produce the "high" associated with marijuana.
The federal thumbs-up comes on the heels of several months of promising research results and a positive preliminary vote from the Food and Drug Administration this spring.
The agency, he added, remains concerned about "the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims". In one study of 120 children and young adults with Dravet syndrome, cannabidiol reduced the median frequency of convulsive seizures to 5.9 a month from 12.4 before treatment, while patients getting a placebo saw minimal reductions, according to results published past year in the New England Journal of Medicine.
With Epidiolex meeting FDA standards, the drug will "finally be made available to the thousands that may benefit from it", he said. Researchers and advocates cautioned against this, however, with the caveat that it's impossible to verify that what's in those products is actually pharmaceutical-grade CBD. GW Pharma says about 6,000 to 10,000 have Dravet Syndrome.
A flowering marijuana plant is pictured at the Canopy Growth Corporation facility in Smiths Falls, Ontario, Canada, January 4, 2018.
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A government-regulated version of the oil will ease some doubts about the amount of CBD in the product, which can vary based on its origin, said Dr. Elaine Wirrell, director of the Mayo Clinic's child epilepsy program. CBD is one of more than 100 chemicals found in marijuana.
"Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes", Gottlieb said. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions.
Jackson's group estimates the typical family using CBD to treat childhood epilepsy spends about $1,800 per year on the substance.
It's not clear how quickly the drug will be available for prescription. Those taking 20 mg of Epidiolex a day had 42 percent fewer seizures, on average, compared with 37 percent fewer seizures in the group taking 10 mg of the drug, and a 17 percent reduction in the placebo group.
Vivian's parents, Brian and Meghan Wilson, elevated the shortcomings of the state's medicinal marijuana program and helped pass a law that led to the availability of a wide range of strains.
The European Medicines Agency is now reviewing Epidiolex for treating seizures associated with LGS and Dravet Syndrome, with a decision on whether or not to recommend approval expected early next year.