A pharmaceutical drug utilizing a non-psychoactive cannabis compound was given a boost in support from American health officials this week, bringing the naturally-derived cannabidiol (CBD) medication one-step closer to total approval from the Food and Drug Administration (FDA).
According to the New York Times, Epidiolex — a seizure-reducing CBD liquid made by British drug firm GW Pharmaceuticals — was given a vote of support in a new FDA Briefing Document released Tuesday, in which members of the federal agency reported positive trials and suggested the drug be approved by the FDA at large.
CBD, a chemical compound found in the cannabis plant that does not have psychoactive effects, has been used to treat a seizures and other ailments in both children and adults for decades. Currently, CBD is sold in both medical and recreational marijuana markets across the country, including a hemp derivative that can be found in health food stores outside of legal weed states.
In the preliminary, non-binding report, the FDA officials concluded that in three studies encompassing over 500 patients, Epidiolex had decreased the amount of seizures in trial patients suffering from both Lennox Gastaut syndrome (LGS) and Dravet syndrome (DS), two types of rare childhood epilepsy, by approximately 40%.
"Clinically meaningful and statistically significant reductions in seizure frequency were demonstrated in three adequate and well-controlled trials in LGS and DS," the FDA report detailed. "The results from these three studies provide substantial evidence of the effectiveness of CBD for the treatment of seizures associated with LGS and DS."
Unlike other attempts from pharmaceutical companies to create synthetic versions of both THC and CBD for America's regulated medical market, Epidiolex is made from CBD taken directly from marijuana plant extracts.
Since naturally-occuring CBD has far fewer side effects than most synthetically-produced pharmaceuticals, Epidiolex trials have included patients as young as three years old. CBD's efficacy in childhood epilepsy treatment has lead to cannabis reform laws in otherwise prohibitionist states, but without clinical trials or FDA approval, doctors across the country have been unable to officially prescribe the potentially life-saving medication.
"The development of a pharmaceutical product tends to cost in the billions of dollars," GW Pharmaceuticals CEO Justin Gover told MERRY JANE last year. "When you're testing and developing a potential prescription drug, you have to prove each step along the way. It's not just, 'Does it work?' We have to show, 'What's its safety profile on its own? What's its safety profile when other drugs are taken at the same time? What's its profile when it's taken with food?' It's that kind of information that we have to show to the satisfaction of the FDA in order to make a medicine like Epidiolex available."
Now, with a positive clinical trial review, Epidiolex will move to a public meeting this Thursday, April 19th, in which a panel of outside experts will speak to the marijuana medication's safety and efficacy.
Even before Thursday's panel meeting though, pharmaceutical investors put their full confidence in the british drugmaker, with Green Market reporting that GW Pharmaceuticals' stock spiked nearly 11% in less than 24 hours after the FDA officials' initial report.
If approved by the outside panel of experts, the CBD pharmaceutical could be granted final FDA acceptance as soon as July of this year.
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