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The drug's approval permits its use in patients aged two years and older with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), rare childhood-onset forms of epilepsy that are among the most resistant to treatment.

United Kingdom based biotech firm, GW Pharmaceuticals has recently received a green signal from the U.S. Food and Drug Administration (FDA) for its Epidiolex drug.

GW CEO Justin Gover said: "This approval is the culmination of GW's many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine". "Lennox-Gastaut Syndrome is a devastating form of epilepsy, and despite now available FDA-approved medications and a poly-therapy approach to treatment, the majority of individuals with LGS will continue to have life-long, debilitating seizures, along with cognitive impairment and an abnormal brain waves on EEG (electroencephalogram)".

FDA Commissioner Scott Gottlieb said in a statement that while the announcement represents a significant scientific achievement, the public shouldn't take it as an overall stamp of approval for marijuana, a Schedule 1 drug with known risks. The trials included 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. CBD is a derivative of marijuana, but the drug only contains small traces of THC, the psychoactive element of the plant, and does not induce an altered perception of being high.

While cannabidiol (CBD) is still considered a Schedule I substance, the FDA determined in their review that its potential for abuse is negligible, and the FDA advises the DEA on controlled substance issues.

Before getting FDA-approved, Epidiolex was tested on over 500 patients with either Lennox-Gastaut syndrome or Dravet syndrome to ensure its effectiveness.

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"Research to demonstrate that marijuana or its components could be safe and effective in the treatment of medical disorders should be held to the same standard as other drug compounds", he said.

"DEA is required to make a scheduling determination". For those in the wellness space, the FDA's high-profile approval could provide a marketing boost.

"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", Gottlieb said.

The FDA has previously approved synthetic versions of another cannabis ingredient for medical use, including severe weight loss in patients with HIV. However, Schultz says his company plans to create more CBD medications.

GW Pharmaceuticals' U.S. commercial business, Greenwich Biosciences, began quietly lobbying to change states' legal definition of marijuana, beginning in 2017 with proposals in Nebraska and South Dakota.

The article does not state exactly when the drug will be on the US market, but generally, FDA approval coincides with market availability.


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