Published: Wed, June 27, 2018
Medicine | By Melba Vasquez

GW Pharma's Epidiolex Becomes First Cannabis-Based FDA-Approved Drug (NASDAQ:GWPH)

GW Pharma's Epidiolex Becomes First Cannabis-Based FDA-Approved Drug (NASDAQ:GWPH)

The Food and Drug Administration approved the medication from GW Pharmaceuticals on Monday to treat two rare forms of childhood epilepsy.

The drug is made from purified cannabidiol, or CBD, a compound found in the cannabis plant. It comes from a proprietary strain of cannabis grown by GW that has been bred to have high levels of CBD and low levels of THC, the component that does make people high. Where is weed legal?

Fox hailed Monday's FDA action as a win for the broader medical marijuana community, in that it will facilitate more clinical research into the drug's medical benefits. Almost all patients with these conditions continue to have daily seizures-some having multiple per day-despite the use of legally available drugs. The agency now has 90 days to reschedule CBD from its rank as a Schedule I drug on the Controlled Substances Act. 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. The company has pushed legislation in several states to make sure its drug can be legally sold and prescribed. Last year, the FDA sent warning letters to a number of CBD manufacturers, demanding that they cease making "unproven" claims that their medicines can fight cancer.

The study also showed that Epidiolex is a safe treatment, with only seven patients dropping out of the trial due to side effects - six from the 20-mg group and one from the 10-mg group.

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More research is still necessary for medical professionals to draw any firm conclusions about CBD's potential to treat seizure conditions. Epidiolex, produced by GW Research Ltd., is now approved to treat the conditions known as Lennox-Gastaut syndrome and Dravet syndrome.

The U.S. approval for Epidiolex was largely expected after an FDA advisory panel endorsed it with a 13-0 vote in April.

Epidiolex was approved for patients age 2 and older who suffer from Lennox-Gastaut and Dravet syndromes. The drug is the first treatment approved for Dravet syndrome.

"In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD", Devinsky said.

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As a result, Epidiolex's launch remains at the discretion of the DEA, which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, so as to allow GW to begin selling it.

Rescheduling cannabidiol means the DEA would remove this substance from its list of Schedule I prohibited substances, which includes drugs like heroin, LSD, and ecstasy.

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. The decision caps decades of work by the company to gain approval in the US for a medicine derived from the cannabis plant.

The FDA's first approval of a cannabis-derived compound happened thanks to sound science, and it must proceed that way.

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