Published: Thu, June 28, 2018
Medical | By Josefina Yates

FDA Approves First Marijuana-Derived Drug

FDA Approves First Marijuana-Derived Drug

FDA approves marijuana-derived drug, the prescription cannabidiol medicine to treat seizures in a subset of patients suffering from rare and severe epilepsy.

The drug, Epidiolex, is derived from 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.

Patients with Lennox-Gastaut and Dravet syndromes, which typically emerge in the first few years of life, can suffer from debilitating and recurrent seizures, sometimes dozens a day.

Epidiolex is approved to treat Lennox-Gastaut and Dravet syndromes in patients age two or older. Both genetic conditions are characterized by frequent seizures and reduced motor skills, including sitting and crawling. Most people with Lennox-Gastaut syndrome require help with usual activities of daily living. But Shauna Garris, a pharmacist highlighted the fact that most of the side effects would occur when the medicine is taken along with other medications, which is a major concern as many patients are already taking other medications.

Currently, CBD-as with other marijuana components-is classified as a Schedule I drug by the DEA. Per regulations, if an ingredient was first studied under a drug IND, it is not permitted to be sold as a food or supplement ingredient. Supporters of the FDA's Epidiolex approval mark it as a major medical milestone, and are hopeful that this will open the doors to further research of cannabis as a medical cure for other ailments. 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.

Upon reviewing the research data for Epidiolex, FDA said it granted priority review designation for its application. Fast-Trackdesignation was granted for Dravet syndrome.

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This drug is also likely to be available made in the United Kingdom and Europe market from mid of 2019, though overtly subject to regulatory approval from European Medicines Agency in early next year.

LGA and Dravet syndrome develop in childhood and are rare, severe forms of epilepsy that are notoriously hard to treat.

FDA Commissioner Dr. Scott Gottlieb called the approval "an important medical advance".

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.

For a 2017 study published in the Journal of the American Medical Association, researchers tested 84 CBD products purchased from 31 different online retailers. Perhaps in anticipation of an onslaught of unfounded medical claims, Gottlieb warned that his agency will "continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims".

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