"The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients' quality of life", said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. The approval marks the first time patients will have access in the U.S.to a cannabis-derived drug that has undergone a safety and efficacy review by the FDA. Humboldt marijuana growers tighten belts for legalizationThe strawberry-flavored syrup is a purified form of a chemical in the cannabis plant - but not the one that gets users high.
"Based on numerous clinical trials, this medication may help meet the need for this specific paediatric patient population and is now the first to be approved by the FDA in Dravet syndrome".
In a call with reporters yesterday, the FDA's commissioner of food and drugs, Scott Gottlieb, MD, said "We remain concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims". The trials included 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. CBD does not contain THC, the psychoactive ingredient in marijuana, so it can not get patients high. 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 tetrahydrocannabinol (THC), the cannabis constituent that produces the euphoric high typically associated with marijuana and cannabis-derived products.
This is the first FDA-approved drug that contains the marijuana-based purified drug. It was shown to be more effective at reducing seizures, when taken with other drugs, than a placebo during these studies.
Epidiolex is now classified as a Schedule I substance because it is a chemical component of the cannabis plant. Some of the side effects of treatment with Epidiolex included, among other, sleepiness, lethargy, diminished appetite, rashes, and infections.
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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.
Justin Gover, CEO of GW Pharmaceuticals, the UK-based company behind the drug, said the approval signals "validation of the science of cannabinoid medication".
50 children in the United Kingdom have been given Epidiolex as a treatment as part of a large scale clinical trial that took in 1,500 kids worldwide. Just a few months ago, news broke of a very encouraging FDA panel assessment, which indicated a positive outlook for the drug's approval.
Gottlieb went on to say that the FDA will support further scientific studies involving the therapeutic potential of marijuana-derived products.
The article does not state exactly when the drug will be on the US market, but generally, FDA approval coincides with market availability.