FDA Approves First Marijuana Based Drug

Glen Mclaughlin
June 27, 2018

More importantly, a DEA representative recently affirmed that outlook, telling Leafly reporter Ben Adlin that if Epidiolex is approved, the DEA will "absolutely" reschedule CBD.

The FDA took pains to specify that clearing Epidiolex for use is not an approval of marijuana or any of its components.

Research has shown that CBD has the potential to treat seizure conditions, like Dravet syndrome. This would be historic as CBD would no longer be listed, alongside the marijuana plant itself, as a Schedule I drug with "no accepted medical use". 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.

FDA said it is providing medical and scientific information and recommendations to the DEA about CBD. The oral drug Epidiolex is intended for patients to treat two rare, and severe forms of epilepsy-Lennox-Gastaut syndrome and Dravet syndrome. FDA chief Scott Gottlieb said his agency had supported research on cannabis-derived products "for many years". Rescheduling cannabidiol paves the way for other advanced cannabinoid formulations, like the ones now being researched and developed by scientists on staff at my Colorado-based cannabinoid science business, ebbu.

The Drug Enforcement Administration must reclassify cannabidiol before GW Pharma can market Epidiolex.

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.

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USA health regulators have approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law.

Some experts believe the anticipated approval will likely open the floodgates for product demand of other CBD products, and place further pressure on the FDA to move it along and approve other CBD-based medications.

Some have said that they have no intention of switching to the new prescription CBD drug because the products they're using are helping their children.

This milestone is expected to help patients ages 2 and older with Dravet and Lennox-Gastaut syndromes. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions. GW Pharmaceuticals grows the plants in the United Kingdom. "I really don't think [the FDA approval is] going to affect us much".

GW said it expects the reclassifying to occur within 90 days.

The drug is derived from the cannabidiol of cannabis, and, as the plant is yet to be decriminalized by federal regulators, its approval gives GW Pharma a lead among cannabis-exposed companies in the USA financial markets. For instance, a clinical trial is underway to test whether CBD can be an effective treatment for people with post-traumatic stress disorder and alcohol use disorder. "This is how sound medical science is advanced".

Other reports by MaliBehiribAe

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