The difference between FDA-approved CBD and ‘regular’ marijuana

27 June, 2018, 13:37 | Author: Denise Dawson
  • AP  File 2017		GW Pharmaceuticals’ Epidiolex a medicine made from the marijuana plant

The Food and Drug Administration on Monday approved the country's first drug derived from marijuana, a medication that treats two rare and devastating forms of epilepsy.

The drug contains cannabidiol, or CBD, a substance derived from marijuana, but causes no intoxication, euphoria or "high", the FDA said. Almost 70 percent of those products had different amounts of CBD than were specified on the product label, with many testing positive for the psychotropic THC even though the products are legally not supposed to have any THC.

In three large clinical trials which the FDA considered before giving Epidiolex the official green light, researchers presented strong evidence that the pharmaceutical-grade CBD in the medicine had the power to significantly curb some of the worst symptoms of two of the hardest-to-treat forms of epilepsy, known as Lennox-Gastaut syndrome and Dravet syndrome.

"We get at least one inquiry a day from patients either using, or considering using, CBD that they ordered online". These companies would love to expand their businesses into every state and are hoping the FDA's June approval of Epidiolex will help pave the way.

Physicians say it's important to have a consistent, government-regulated version. "But it's also important to note that this is not an approval of marijuana or all of its components".

And Epidiolex's approval doesn't mean other CBD substances are OK to sell, Gottlieb said. There was some concern about the drug's effects on the liver, but experts have said this risk could be addressed by doctors as they monitor their patients during treatment.

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In clinical trials, children with Dravet syndrome who took Epidiolex experienced 39 percent fewer seizures; those with Lennox-Gastaut syndrome saw a 37 percent decrease. From Walmart to CVS to the Mom-n-Pop drugstores still kicking it Smalltown, USA - legitimate cannabis medicine will be available in the same way as other prescription drugs. British drugmaker GW Pharmaceuticals expects the oral solution to hit the market this fall. Under the Controlled Substances Act, marijuana is a Schedule I drug, meaning it has a high potential for abuse and no recognized medical objective (heroin, LSD, and ecstasy are also Schedule I drugs).

USA health regulators on Monday approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical 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.

The agency, he added, remains concerned about "the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims".

GW Pharma won't be able to launch the drug right away, however, because its active ingredient, CBD, needs to be rescheduled by the DEA. And the company plans to continue importing the medicine, bypassing onerous US regulations on manufacturing restricted substances.

The FDA's first approval of a cannabis-derived compound happened thanks to sound science, and it must proceed that way.

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