First marijuana-derived drug approved, will target severe epilepsy

FDA approves first cannabis-based drug


Cannabis, including CBD, is a "schedule 1" drug, meaning it has no medicinal value and poses a high risk for abuse. 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.

Not only is the first marijuana-derived drug approved by the FDA, but the first FDA approval of a drug for the treatment of patients with Dravet syndrome.

And Epidiolex's approval doesn't mean other CBD substances are OK to sell, Gottlieb said.

Parents treated their children's seizures with CBD oil years before the FDA backed any drug.

Prior approval has been granted for medicines derived from synthetic cannabinoids.

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On a call with reporters on Monday, FDA Commissioner Scott Gottlieb, M.D., cautioned that Epidiolex's green light is not an approval for marijuana but an approval for "one specific CBD medication for a specific use" based on well-controlled clinical trials. It does not contain THC, the well-known psychoactive component of marijuana responsible for the drug's characteristic high. CBD is one of more than 100 chemicals found in marijuana.

He added, "This is how sound medical science is advanced". According to the New York Times, analysts expect Epidiolex to cost $2,500 to $5,000 a month.

Since receiving Epidiolex, Hendershot says her daughter has been able to concentrate more and has had fewer "drop" seizures - in which her entire body goes limp and collapses.

Ohio's medical marijuana program was expected to be operational in early September but now has no definite start date, and none of the approved cultivation centers has begun growing the plant. "Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases". However, it isn't clear whether CBD, in general, would be reclassified or CBD as used in an FDA-approved product.

There are likely to be drug interactions, she said, but "that's not uncommon for antiepileptic medications", and she noted that this could affect the effectiveness of the medication. "Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery".

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Although several states have legalized the medical and recreational use of marijuana, the federal agency had yet to do so until today.

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, so as to allow GW to begin selling it.

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.

"Hopefully this day and announcement, which will lead to rescheduling, will open up the possibilities for research in other areas", Patel said.

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