USA approves first marijuana plant-derived drug for epilepsy

Grant Boone
June 26, 2018

Today's approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies.

A new drug derived from marijuana just became the first of its kind to get the green light from the U.S. government.

Epidiolex will be marketed by Greenwich Biosciences, a subsidiary of GW Pharmaceuticals.

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 USA financial markets.

The strawberry-flavored syrup is a purified form of a chemical ingredient found in the cannabis plant - but not the one that gets users high.

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.

FDA Commissioner Scott Gottlieb said the agency "will continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products". 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. 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.

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"Hopefully this day and announcement, which will lead to rescheduling, will open up the possibilities for research in other areas", Patel said. Most producers say their oil is made from hemp, a plant in the cannabis family that contains little THC and can be legally farmed in a number of states for clothing, food and other uses.

Treatments available for both disorders are far from ideal and some patients resort to buying "self-prescribed" CBD online or from unregulated vendor sites, Dr. Pavel Klein, founder of the Mid-Atlantic Epilepsy and Sleep Center, said. Any drug containing cannabis from here on out will still need to clear plenty of hurdles before getting approval. It compared two different doses of Epidiolex head-to-head and against an inactive placebo, Devinsky said. This is called off-label use and is a common practice with many medications.

"Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others", said the FDA.

Dravet syndrome is a rare genetic condition that causes frequent fever-related seizures, involuntary muscle spasms and a potentially life-threatening state of continuous seizure activity requiring emergency medical care.

The FDA is not required to follow the advisory panel's advice but usually does. A prescription drug provides a workaround to this issue. That decision is expected within 90 days.

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.

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