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

FDA approves first cannabis-based drug

The US pharmacies were allowed to sell the drug out of marijuana

Cannabidiol (CBD) is the first FDA-approved drug derived from marijuana and the first FDA-approved drug to treat patients with Dravet syndrome. It doesn't contain THC, the ingredient that gives marijuana its mind-altering effect.

According to Dr. Angel Hernandez, of the Helen DeVos Children's Hospital in Grand Rapids, Mich., these results prove that pharmaceutical-grade CBD helps suppress seizures and "increases our options to treat many of these patients with very, very difficult-to-control epilepsies".

The FDA previously cleared medications containing synthetic versions of THC for nausea for patients getting chemotherapy and for other uses, but it had not approved any drug derived from the plant itself.

GW Pharmaceuticals, the British company responsible for the drug, said now approved AEDs (anti-epileptic drugs) are not always effective in the majority of patients with Lennox-Gastaut Syndrome (LGS) and Dravet syndrome - severe forms of childhood-onset epilepsy.

Side effects included sleepiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, weakness, insomnia, poor quality sleep and infections.

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Once the DEA gets the FDA recommendation for how CBD should be scheduled, it has 90 days to decide. The drugmaker is testing other CBD treatments for glioblastoma and schizophrenia.

Gover said the approval signals "validation of the science of cannabinoid medication".

The FDA is not required to follow the advisory panel's advice but usually does.

"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. The Figi family, whose daughter Charlotte was diagnosed with Dravet syndrome at 3 months old, has been extremely vocal about medical marijuana's merits.

"Compared to other drugs used to treat epilepsy, I think Epidiolex, which is 99-percent pure cannabidiol, has a better side-effect profile than numerous available drugs", Devinsky said.

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GW Pharma grows its own supply of cannabis in specialized glass houses in the United Kingdom to ensure uniformity in the genetic composition of the plants, which are then processed into a liquid solution of CBD.

The new medication enters an increasingly complicated legal environment for marijuana.

Despite increasing acceptance, there is little rigorous research on the benefits and harms of marijuana.

With the historic approval, the London-based company behind the drug, GW Pharmaceuticals plc, is expecting another consequential decision in the coming weeks: getting the US Drug Enforcement Administration to reclassify CBD.

Still, this approval comes as the White House is said to be reconsidering federal prohibition of marijuana and as more and more states approve it for recreational and medicinal use. A year ago a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health.

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Many companies sell cannabis-based treatments, touting them as cancer cures, pain relievers and anxiety medicines. European approval is expected in early 2019.

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