GW Pharma's Epidiolex Becomes First Cannabis-Based FDA-Approved Drug (NASDAQ:GWPH)

Ebony Scott
June 26, 2018

"For a maligned substance like cannabis, I think the vindication tour will ultimately be years long", said Ricardo Baca, a former marijuana editor at the Denver Post, and the founder of Grasslands, a cannabis PR agency.

As a result, Epidiolex's launch remains at the discretion of the DEA which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, which would allow GW to begin selling it.

Epidiolex, manufactured by GW Pharmaceuticals in the United Kingdom, is made from cannabidiol, the non-psychoactive part of the cannabis plant. It is the fourth marijuana-based medicine to receive US FDA approval - joining dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros).

Many families have moved to states where marijuana is legal medically or recreationally so they could treat their children with CBD on their own.

US Food and Drug Administration Commissioner Dr Scott Gottlieb said: "This is an important medical advance".

Epidiolex, made by the British company GW Pharmaceuticals, is now marketed to treat two forms of severe childhood epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.

"This is clearly a breakthrough drug for an very bad disease", John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug. Researchers and advocates cautioned against this, however, with the caveat that it's impossible to verify that what's in those products is actually pharmaceutical-grade CBD.

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Although THC can induce paranoia, anxiety and hallucinations, CBD has the opposite effects and has been cited by scientists as a potential treatment for mental health issues. This is the approval of one specific CBD medication for a specific use.

"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.

Cannabidiol is derived from the cannabis plant, also known as marijuana.

That's because these kids did not experience as many side effects from the cannabidiol, which can include tiredness, decreased appetite, diarrhea and signs of possible liver damage, Devinsky explained.

It's an option for those patients who have not responded to other treatments to control seizures.

Gottlieb hinted at additional enforcement actions against companies that sell unregulated CBD products with medical claims that aren't backed up by evidence. "Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases".

Justin Gover, chief executive officer of GW Pharmaceuticals, described the approval in the statement as "a historic milestone". That decision is expected within 90 days. 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.

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