Epilepsy Treatment Derived From Marijuana Approved for US Sales

Desiree Steele
June 28, 2018

The drug set to be launched in autumn in the United States market is for treating rare and severe forms of epilepsy - Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients aged 2 and older.

Elizabeth Thiele, director of the paediatric epilepsy programme at Massachusetts General Hospital, professor or neurology at Harvard Medical School and a lead investigator in the Epidiolex clinical programme, said: "LGS and Dravet syndrome are two of the most severe and difficult-to-treat forms of childhood-onset epilepsy". 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. Epidiolex is the first FDA-approved drug that contains CBD, a purified substance sourced from marijuana.

The news story further emphasizes that the marijuana compound - CBD - contains too little of the psychoactive part of the plant, THC, to cause the "high" associated with recreational use. This includes seizures from two types of rare epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

FDA commissioner Scott Gottlieb has said that it is committed to this kind of careful scientific research and drug development making these kinds of important medical advances. The trials included 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome.

The administration pointed out that unlike THC, a more well-known chemical component of marijuana, CBD doesn't cause intoxication.

The drug that was just approved is only for rare forms of epilepsy, but Bainbridge is now working on a few other clinical trials that have ingredients derived from marijuana. FDA staff said at an April meeting on the drug with outside advisers that cannibidiol, known as CBD, "does not appear to have abuse potential".

Epidiolex is now classified as a Schedule I substance because it is a chemical component of the cannabis plant.

The most common side effects that occurred in Epidiolex-treated patients in the clinical trials were: sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections. However, with Epidiolex, patients will be able to get a high-grade, medically regulated dosage each time they take it.

"I believe there is going to be an even larger emergence of CBD [and other marijuana] companies touting their [products] as beneficial and using this approval as their basis, " said Kelvin Harrylall, the CEO of the CBD Palace, which audits CBD companies and creates a list of vendors it deems safe for customers.

Will we see a flood of CBD products? "It's an fantastic plant with so many different chemical compounds that can fix medical problems", Defran said. The company has pushed legislation in several states to make sure its drug can be legally sold and prescribed.

The article does not state exactly when the drug will be on the USA market, but generally, FDA approval coincides with market availability.

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