FDA Approves First Drug Derived From Marijuana Plant

Ebony Scott
June 27, 2018

The United States Food and Drug Administration (USFDA) on Monday approved the first marijuana-derived drug to enter the US market - a medication to treat two rare and severe forms of childhood epilepsy.

The drug, Epidiolex, is made up of cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant, and contains less than 0.1 percent of tetrahydrocannabinol (THC), the psychoactive component that makes people high.

The medicinal acknowledgment of CBD should come as good news to marijuana startups eyeing the compound for consumer and medical consumption.

This drug is a treatment option of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.

Most patients with LGS and DS require multiple seizure medications and the majority are resistant to now approved anti-epileptic drugs.

"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies" said FDA Commissioner Scott Gottlieb.

The approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle. Once the FDA approves the drug, expected by the end of June, doctors will be able to prescribe it legally.

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Most patients with LGS and Dravet syndrome require multiple seizure medications and the majority are resistant to now approved anti-epileptic drugs. The DEA's decision is expected to be made within 90 days.

While the FDA had not previously approved any drug directly deriving from marijuana, it has marketed some containing a synthetic version of THC. Marijuana and its components, including CBD, are Schedule 1 controlled substances - meaning they are banned because they are thought to have a high abuse potential, no medical value and serious safety implications.

Shlomo Shinnar, president of the American Epilepsy Society and a neurologist at Montefiore Medical Center in NY, has said the drug will be "a very valuable addition" to the limited options for treating severe childhood-onset epilepsy. 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.

"I preferred this to some of those other options because it's is a commercial product that has gone through rigorous testing", said Hendershot, who lives in Rochester, New York.

"We anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant", Armentano continued. The administration would then presumably reclassify cannabidiol in a less restrictive schedule (the DEA has five drug schedules, with Schedule I being the most restrictive and Schedule V being the least restrictive).

The FDA is not required to follow the advisory panel's advice but usually does.

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.

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