US OKs marijuana-based prescription drug for seizures

FDA approves first ever drug derived from marijuana | TheHill

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

Jackson's group estimates the typical family using CBD to treat childhood epilepsy spends about $1,800 per year on the substance. 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). 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 previous year in the New England Journal of Medicine. Last year, the FDA sent warning letters to a number of CBD manufacturers, demanding that they cease making "unproven" claims that their medicines can fight cancer.

The U.S. Food and Drug Administration has approved a naturally derived CBD drug, a landmark decision that will trigger the health agency to seek rescheduling for the cannabinoid from the Drug Enforcement Administration (DEA).

"Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others", said the FDA.

"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 that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes", Gottlieb said.

Even though 16 percent of trial participants experienced unwelcome side effects, such as diarrhea, vomiting and abnormal liver function, FDA officials and an advisory panel unanimously recommended its approval.

He added: "We anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant".

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Epidiolex would also be the first approved therapy for DS, treatments for which are now limited to a combination of seizure medication and drugs to prevent emergencies.

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

For medical marijuana advocates, it's a clear vindication of a fundamental premise of a decadeslong movement: that cannabis can have legitimate medical applications and it isn't the bogeyman that the federal government has long made it out to be. British drugmaker GW Pharmaceuticals expects the oral solution to hit the market this fall.

A phase three clinical trial is underway for a third seizure-related condition called tuberous sclerosis complex, which begins in infancy and causes a sudden stiffening of the body, arms and legs, with the head bent forward. The DEA's decision is expected to be made within 90 days.

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.

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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