Wednesday, 19 September, 2018

United States approves first marijuana plant-derived drug for epilepsy

United States approves first marijuana plant-derived drug for epilepsy United States approves first marijuana plant-derived drug for epilepsy
Isabel Fisher | 28 June, 2018, 11:19

The drug - called Epidiolex - employs cannabidiol (CBD), a chemical component in marijuana, to treat two rare and severe forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome, the FDA said in a press release.

GW Pharmaceuticals' Epidiolex has become the first cannabinoid prescription medicine to be approved in the U.S., winning clearance to treat two rare forms of epilepsy.

"The FDA's approval of this plant-derived medicine provides an additional option to patients seeking the therapeutic benefits of cannabis", said NORML Deputy Director Paul Armentano.

Shaun Hussain, MD, a pediatric neurologist at Ronald Reagan UCLA Medical Center in Santa Monica, says that while the FDA's approval of a marijuana-based drug is "indeed a big deal", it is also significant because "it offers another drug for Lennox-Gastaut and the first-ever drug for Dravet".

That includes Dravet syndrome, a genetic dysfunction in the brain that appears within the first year of life.

So how do you get medical marijuana treatment in Southwest Florida? Outside the USA, this medicine is now under review by the European Medicines Agency (EMA) for the treatment of seizures associated with Dravet Syndrome and LGS.


In states where marijuana has been legalized, thousands of cannabis startups sell pens, oils, and edibles that contain either CBD, THC, or both ingredients.

Cannabidiol (CBD) is a compound derived from the cannabis plant that does not produce a "high" and has been an increasing focus of medical research in epilepsy. It's the first drug approved by the FDA for the treatment of Dravet syndrome. The report by Stat goes on to add that analysts predict the drug might be used to treat forms of epilepsy other than DS and LGS. Some of the side effects of treatment with Epidiolex included, among other, sleepiness, lethargy, diminished appetite, rashes, and infections.

Stephen Schultz, vice president of investor relations for GW Pharmaceuticals, said the company expects to launch Epidiolex in the fall, pending scheduling from the DEA. "And, the FDA is committed to this kind of careful scientific research and drug development", FDA Commissioner Scott Gottlieb, M.D., said in a statement. We'll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products.

This one landmark approval could have another one following it soon: the reclassification of CBD by the United States Drug Enforcement Administration. Interestingly, the warning focused not on the products' CBD content as violative of the CSA, but instead on the unproven and potentially fraudulent nature of the product's marketing representations.

The FDA's decision was not unexpected, as the proprietary extract formulation - developed by the British biotechnology firm GW Pharmaceuticals - had previously demonstrated safety and clinical efficacy at reducing seizure frequency in several placebo-controlled trials. Catherine is part of the drug company's clinical trial.

The other epilepsy drugs in the market lead to serious risks like suicidal thoughts and attempts.

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