A new drug derived from marijuana just became the first of its kind to get the green light from the United States government.
While there was initially some confusion about whether the Drug Enforcement Administration might block the sale of Epidiolex, given cannabis' status as a Schedule I substance, Epidiolex manufacturer GW Pharmaceuticals doesn't believe that will be the case.
CBD has medicinal effects, but it does not cause the mind-altering high that comes from THC, the primary psychoactive component of marijuana.
While most hemp-derived CBD companies are rapidly growing their businesses without repercussion or worry, many cannabis CBD businesses are hesitant about selling products in states where marijuana is not yet legal.
"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies", said Food and Drug Administration Commissioner Scott Gottlieb.
Having an FDA-approved, pharmaceutical-grade CBD drug will open up a new treatment option for epilepsy patients by delivering a high-quality, consistent dose of CBD, says Robert Carson a pediatric neurologist at Vanderbilt University who treats patients with epilepsy.
FDA's Gottlieb warned about the use of CBD products with "unproven medical claims".
Federal agencies have 90 days to determine the scheduling of Epidiolex.
A flowering marijuana plant is pictured at the Canopy Growth Corporation facility in Smiths Falls, Ontario, Canada, January 4, 2018.
"The DEA will not prevent Epidiolex from being sold", Fox said Monday.
GW Pharmaceuticals manufactures another cannabis-derived drug, Sativex, which helps treat muscle spasms from multiple sclerosis.
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. "This is the approval of one specific CBD medication for a specific use. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases".
The FDA is not required to follow the advisory panel's advice but usually does.
The drug should provide a more reliable alternative than the homemade cannabis oil parents for years have made for the children, said Devinsky, who once treated Vivian Wilson of Scotch Plains, a toddler with Dravet syndrome.
Medical marijuana is available in about half of the states.
The company has not said how much the drug will cost, but Wall Street analysts have predicted it could cost $25,000 per year. 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.
The FDA's decision was expected.
The European Medical Society is also considering approval of Epidiolex and is expected to announce a decision in the first quarter of next year, according to Gover.