The FDA May Approve Its First Cannabis-Based Drug This Week

FDA approves first ever drug derived from marijuana | TheHill

Even though there are numerous approved epilepsy drugs, Dr. Devinsky says there's a pressing need for something like Epidiolex because it has a completely different, and better tolerated, formula for patients.

The drug is the "first pharmaceutical formulation of highly-purified, plant-based cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs", according to a statement Monday from GW Pharmaceuticals, the UK-based biopharmaceutical company that makes Epidiolex.

Epidiolex is made of CBD (cannabidiol), a cannabis chemical compound of marijuana that does not cause tightness. And of course, the fact that it is approved for children over the age of 2 is applause-worthy in and of itself, as this is the first time a cannabis-based drug has been approved for children.

The effectiveness of Epidiolex has forced parents who have children suffering from epilepsy to move to states where marijuana has been legalized. "But it's also important to note that this is not an approval of marijuana or all of its components". The syndromes treated include Dravet syndrom and Lennox-Gastaut syndrome.

The drug's approval permits https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf 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.

Patients with Lennox-Gastaut and Dravet syndromes, which typically emerge in the first few years of life, can suffer from debilitating and recurrent seizures, sometimes dozens a day. This classification conflicts with the FDA's approval of its medicinal use, and signals hope that this compound will soon find its way off the DEA's list. In one study of 120 children and young adults with Dravet syndrome, cannabidiol reduced the median frequency of convulsive seizures to 5.9 a month from 12.4 before treatment, while patients getting a placebo saw minimal reductions, according to results published past year in the New England Journal of Medicine. And, as NPR has reported, CBD supplements are available widely online and in dispensaries in the form of oils or tinctures. The agency explained that the drug contains CBD, and not THC, and is hence not psychoactive in any way. "It's being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits", Gottlieb said. The DEA recently published an internal directive stating that6 CBD from hemp is mostly legal.

"We'll 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", furthered Dr Scott. "This is how sound medical science is advanced". "I really don't think it's going to affect us much".

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