The U.S. Food and Drug Administration has approved a marijuana-deriveddrug for the treatment of two rare and serious forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, that begin in childhood but can persist in adulthood.
Patel helped run trials here testing Epidiolex to treat Dravet syndrome and Lennox-Gastaut syndrome, two rare, often drug-resistant forms of epilepsy that start in childhood.
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.
Many parents already are giving children unregulated CBD formulations that are available in medical marijuana dispensaries in the many states where such operations are legal.
Several researchers are studying the potential of CBD to treat psychiatric conditions. GW won't be able to market Epidiolex until the DEA reclassifies CBD.
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The drug contains nearly non of the psychoactive chemical from marijuana that makes people high and proved through testing to be effective in treatment of certain pediatric seizure patients. In a statement released today, FDA notes that it "has taken recent actions against companies distributing unapproved CBD products". She says this is a step forward for other families suffering all across the country.
Now with the approval of Epidiolex, a drug that will not produce an euphoric "high" feeling in the user - Devinsky said he expected CBD would be moved down to a schedule 4 or 5 drug, which is one that poses a low potential for abuse and dependence. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions.
The medication, which will continue to be manufactured in Britain, will be marketed by Greenwich Biosciences, the USA subsidiary of GW Pharmaceuticals. "I really don't think [the FDA approval is] going to affect us much". She has not used Epidiolex in her own clinical practice and was not involved in the development of the drug but said she's not sure it will live up to "all of the hype" that has surrounded it.
Nine states and the District of Columbia have legalized marijuana for recreational use. And even the ones that do are far from having the blessing of the federal government, and therefore are not covered through any insurance network.
Epidiolex is under review in Europe as well, and GW expects a decision from the European Medicines Agency in the first quarter of next year.
"And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition", he continued. One in five patients is estimated to die before they are 20 years old. European approval is expected in early 2019. The AP is exclusively responsible for all content.