FDA Approves Country's First Marijuana-Based Medicine

The drug is made of cannabidiol (CBD), a component of marijuana that doesn't give users a high.

The U.S. Food and Drug Administration on Monday approved Epidiolex, which contains marijuana compound cannabidiol or CBD, to treat two types of severe epilepsy.

The drug is derived from the cannabidiol of cannabis, and, as the plant is yet to be decriminalized by federal regulators, its approval gives GW Pharma a lead among cannabis-exposed companies in the US financial markets. Where is weed legal? "However, we remain concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims". Once the FDA approves Epidiolex, the DEA will be compelled to deschedule it from a Schedule I drug on the Controlled Substances Act (defined as "no recognized medical use") to either a Schedule II or III drug. This is called off-label use and is a common practice with many medications. A published study in the Journal of the American Medical Association (JAMA) showed tremendous variability in 84 CBD products tested.

Since receiving Epidiolex, Hendershot says her daughter has been able to concentrate more and has had fewer "drop" seizures - in which her entire body goes limp and collapses. 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.

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.

The FDA is not required to follow the advisory panel's advice but usually does.

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Industry supporters downplayed the impact of the FDA approval. 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 a year ago in the New England Journal of Medicine. The floodgate effect is known as "sea change", as described by Barbara Carreno, public affairs officer for the U.S. Drug Enforcement Administration (DEA). But GW said it expects that the DEA will reschedule CBD within 90 days. 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 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. Patients experience frequent, severe seizures, in some cases more than 100 per day.

The FDA's decision was expected.

Another 20 states allow medical marijuana, but the US government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.

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.

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