FDA Approves First Marijuana-Derived Drug

FDA Approves First Marijuana-Derived Drug

GW Pharmaceuticals Plc's epilepsy treatment on Monday secured an approval from the U.S. Food and Drug Administration, becoming the first cannabis-based drug to be approved in the country.

While the DEA still classifies all other cannabis-derived medicines as Schedule I drugs with no medical value, the agency will have to choose a different schedule for Epidiolex now that the FDA has approved its medical use.

"Compared to other drugs used to treat epilepsy, I think Epidiolex, which is 99-percent pure cannabidiol, has a better side-effect profile than numerous available drugs", Devinsky said. As well, CBD remains in a legal grey area, making it hard for patients outside of legal states to acquire. 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 FDA is willing to help companies that want to pursue such research programs, he said, but they need to prove their products work and are safe with data from clinical trials.

The drug is called Epidiolex and is a plant-derived oral solution of cannabidiol (CBD)-a chemical component of marijuana that does not cause intoxication or a euphoric "high". The FDA has previously sent warning letters to companies that hyped their products as cancer or Alzheimer's fighters.

The FDA took pains to specify that clearing Epidiolex for use is not an approval of marijuana or any of its components.

"I'm really happy we have a product that will be much cleaner and one that I know what it is", Wirrell told the Associated Press. "And, the FDA is committed to this kind of careful scientific research and drug development", FDA Commissioner Scott Gottlieb, M.D, said.

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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. ABC News also confirmed this expected timeline with Christy Curran, spokesperson for GW Pharmaceuticals. The six-month supply can be used to treat the boy's seizures, which, without the medication, could number up to 100 a day.

For years, families of children with severe seizure issues have been turning to marijuana-based substances to find relief from debilitating episodes, often skirting the law to obtain what they said was their only effective treatment option. The floodgate effect is known as "sea change", as described by Barbara Carreno, public affairs officer for the U.S. Drug Enforcement Administration (DEA).

A reclassification is expected within 90 days, according GW Pharmaceuticals.

Gottlieb emphasized that the approval of Epidiolex does not have any implications for the approval of marijuana as a medicine more broadly, but the move is still widely seen by the industry as a significant step towards acceptance of 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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