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.
In a statement accompanying Monday's approval announcement, the FDA hastened to note that it's not signing off on the safety or medical utility of marijuana in general ― just this one compound and only for this limited use. This decision comes despite the fact that the US Drug Enforcement Agency lists the plant itself as a schedule 1 drug-meaning it has no recognized uses with a high potential for abuse.
Zaki Jackson is 15 years old now and living with a rare form of epilepsy called Doose syndrome. What's more, the DEA will reportedly reschedule CBD in light of the FDA's decision, greatly loosening restrictions on research.
There are six other drugs approved to treat seizures associated with Lennox-Gastaut, but none approved for Dravet. It is the fourth marijuana-based medicine to receive US FDA approval - joining dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros). But thanks to a cannabis extract dubbed Charlotte's Web, Zaki's seizures all but stopped entirely. The administration would then presumably reclassify cannabidiol in a less restrictive schedule (the DEA has five drug schedules, with Schedule I being the most restrictive and Schedule V being the least restrictive).
"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.
Side effects with the drug include diarrhea, vomiting, fatigue and sleep problems.
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In April, an advisory committee to the FDA voted unanimously that the risk-benefit profile for Epidiolex was favorable. This is the approval of one specific CBD medication for a specific use. "He was able to come off of all his pharmaceuticals and his condition went into complete remission for four years", Jackson said.
Nasdaq-listed GW Pharmaceuticals, which grows its own marijuana plants in glass houses in Britain, hopes the drug will be approved in the United Kingdom next year.
Epidiolex's effectiveness was studied in three randomized clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome, comparing Epidiolex to a placebo. Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy.
The medication, which will continue to be manufactured in Britain, will be marketed by Greenwich Biosciences, the US subsidiary of GW Pharmaceuticals. "I really don't think it's going to affect us much". The company is also looking beyond CBD at uses for marijuana compounds that range from neurological conditions to diseases like multiple sclerosis and cancer to other issues like pain.
GW said it expects the reclassification to occur within 90 days. "This is how sound medical science is advanced".