FDA Approves First Marijuana Based Drug

Marissa Parsons who has Lennox Gastaut syndrome visits the Grand Canyon with her family in 2016

Marissa Parsons who has Lennox Gastaut syndrome visits the Grand Canyon with her family in 2016

United States regulators on Monday approved the first marijuana-derived drug ever to hit the U.S. market, Epidiolex, which will be used to treat two rare and severe forms of childhood epilepsy.

The drug is the "first pharmaceutical formulation of highly-purified, plant-based cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs", according to a statement Monday from GW Pharmaceuticals, the UK-based biopharmaceutical company that makes Epidiolex.

GW Pharmaceuticals, the British company responsible for the drug, said now approved AEDs (anti-epileptic drugs) are not always effective in the majority of patients with Lennox-Gastaut Syndrome (LGS) and Dravet syndrome - severe forms of childhood-onset epilepsy.

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. The drug is a strawberry-flavored syrup made by British company GW Pharmaceuticals.

In 1985, the FDA signed off on Marinol, which contains a synthetic version of THC, to treat loss of appetite in people with AIDS.

"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies", FDA Commissioner Scott Gottlieb said.

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FDA said it is providing medical and scientific information and recommendations to the DEA about CBD. It's given as an oil, and in clinical trials, it was show to reduce the number of seizures by about 40 percent.

"Our families have been waiting for this exciting announcement", CEO of Epilepsy Foundation Central and South Texas, Sindi Rosales said. But FDA officials have said they believed the risks were manageable if cautionary language was placed in the drug's prescribing label, and if the agency monitored liver risk after the drug was on the market.

The goal is have it available in pharmacies by the end of the year, said Orrin Devinsky, a pediatric neurologist and director of the New York University-Langone and Saint Barnabas Comprehensive Epilepsy Center in Livingston, who co-authored the research. Schedule I drugs include heroin and LSD as well as marijuana.

Gottlieb noted that the action was "not an approval of marijuana or all of its components" but rather of one specific CBD medication for a particular use.

The approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle. Accordingly, before Epidiolex is ready for use amongst patients, it needs to be appropriately reclassified - something GW Pharmaceuticals expects to see happen within the next three months.

Shauna Garris, a pharmacist, pharmacy clinical specialist and adjunct assistant professor at the University of North Carolina's Eshelman School of Pharmacy, said the drug is effective and works somewhere between "fairly" and "very well". This treatment we have studied for the last five years.

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