With the historic approval, the London-based company behind the drug, GW Pharmaceuticals plc, is expecting another consequential decision in the coming weeks: getting the US Drug Enforcement Administration to reclassify CBD.
The oral solution contains cannabidiol, or CBD, a nonpsychoactive compound that has proved beneficial in reducing the catastrophic, potentially life-threatening seizures that accompany both conditions. Where is weed legal? What's more, the DEA will reportedly reschedule CBD in light of the FDA's decision, greatly loosening restrictions on research.
Federal agencies have 90 days to determine the scheduling of Epidiolex.
Proponents of medical marijuana have heralded the substance as the "answer to the opioid crisis" for relieving chronic pain with nonfatal side effects. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician's care. This drug does not contain THC, which is the part of the marijuana plant that would get someone high.
Ohio's medical marijuana program was expected to be operational in early September but now has no definite start date, and none of the approved cultivation centers has begun growing the plant. It doesn't contain THC, the ingredient that gives marijuana its mind-altering effect.
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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.
In the meantime, it is possible that once on the market, Epidiolex could be prescribed for conditions other than the ones it's approved for.
"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.
FDA's Gottlieb warned about the use of CBD products with "unproven medical claims".
Called Epidiolex, the drug is created to treat two rare forms of childhood epilepsy using a cannabis compound called cannabidiol (or CBD). The company has not yet set a price for the drug and said it would work with insurance providers to ensure the medicine would be covered under health plans.
The medicinal acknowledgment of CBD should come as good news to marijuana startups eyeing the compound for consumer and medical consumption. The Figi family, whose daughter Charlotte was diagnosed with Dravet syndrome at 3 months old, has been extremely vocal about medical marijuana's merits.