FDA Approves First Marijuana-Derived Drug

Grant Boone
June 30, 2018

On Monday the agency approved its first marijuana-derived drug, Epidiolex, for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, two rare forms of pediatric epilepsy.

First, the Drug Enforcement Agency (DEA) still classifies marijuana as a Schedule 1 drug, alongside heroin and other deadly substances.

The most common side effects of Epidiolex in clinical trials were sleepiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, fatigue, malaise and weakness, insomnia, sleep disorder, poor quality sleep, and infections, the FDA says.

But the tide is changing, and a year ago, a government-commissioned group of experts concluded that the U.S.is creating a risk to public health by not engaging in more research about cannabis and CBD in particular.

While the FDA had not previously approved any drug directly deriving from marijuana, it has marketed some containing a synthetic version of THC. "Nonetheless, these alternatives should not be regulated as options to replace the use and regulation of herbal cannabis - a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 30 states".

CEO of GW Pharmaceuticals plc, Justin Gover stated, "This approval is the culmination of GW's many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine". The Food and Drug Administration OKs country's first marijuana-based drug called Epidiolex on Monday.

Lennox-Gaustaut syndrome is estimated to account for between one and four percent of all cases of childhood epilepsy.

How major U.S. stock indexes fared Monday
Japan's benchmark Nikkei 225 index dropped 0.5 percent to 22,221.33 and South Korea's Kospi lost 0.9 percent to 2,337.60. Chipmakers and US -listed Chinese companies were among the most traded stocks in premarket trading on Monday.

Like Dravet syndrome, Lennox-Gastaut syndrome also begins in childhood and causes multiple types of seizures. The FDA said Epidiolex was tested in three clinical trials involving 516 people with the syndromes and was found to be effective at reducing the frequency of seizures better than a placebo when taken in conjunction with other medications.

"And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition", he continued. This classification conflicts with the FDA's approval of its medicinal use, and signals hope that this compound will soon find its way off the DEA's list.

"Moreover, this is a purified form of CBD", Gottlieb continued. "It's being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits", Gottlieb said.

In the meantime, it is possible that once on the market, Epidiolex could be prescribed for conditions other than the ones it's approved for.

"This is an important medical advance". The companies behind those products say the CBD is extracted from hemp, which contains little THC, and is allowed under the federal farm bill.

It's unclear at this time whether Epidiolex receiving FDA approval will move marijuana to a different class of drugs in the future, or how this will affect CBD research in the future.

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