Published: Sat, June 30, 2018
Health Care | By Cedric Leonard

FDA Approves First Marijuana-Derived Drug

FDA Approves First Marijuana-Derived Drug

Today marks a turning point in the marijuana market as the first ever FDA-approved cannabis drug, "Epidiolex", is going to be the trailblazer for cannabis-derived medicines in the U.S. GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) will supply the drug to the U.S. market via its subsidiary, Greenwich Biosciences Inc.

First, the Drug Enforcement Agency (DEA) still classifies marijuana as a Schedule 1 drug, alongside heroin and other deadly substances.

GW Pharmaceuticals makes the drug in the United Kingdom from cannabis plants that are specially bred to contain high levels of CBD.

Epidiolex is made of CBD (cannabidiol), a cannabis chemical compound of marijuana that does not cause tightness. This is the first time the agency has approved a medication with an active ingredient that comes from marijuana. 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.

A recent TechCrunch article noted a new milestone achievement for companies and patients pushing for the acceptance of medical marijuana. It's important to note that as a large pharmaceutical company, GW provides a much different play versus traditional marijuana companies. The drug also is being reviewed for sale in Europe and a decision on that review is due in the first quarter of next year.

Lennox-Gaustaut syndrome is estimated to account for between one and four percent of all cases of childhood epilepsy.

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The drug is meant to treat seizures in those 2 years and older who suffer from Dravet Syndrome and Lennox-Gastaut Syndrome, both very rare forms of childhood epilepsy.

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. However, Schultz says his company plans to create more CBD medications. "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)".

"And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition", he continued. The industry on cannabis has been working to combine that of the pharmaceutical industry for some time now given how much potential cannabis has to treat a wide variety of diseases and ailments.

"This is a purified form of CBD".

He added, "This is how sound medical science is advanced". "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 explained this wouldn't be the only CBD-based medication hitting the market.

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