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FDA Approves Landmark Marijuana-Derived Drug First Tested at UCSF



30th June 2018 – By For the first time, a marijuana drug was approved by the Food and Drug Administration, and it could soon bring relief to children at serious health risk – confiscation. In 2013, UCSF Benioff Children's Hospital San Francisco became the first site to administer the drug in a child, and as of this week, the FDA has approved its use in two rare and devastating forms of epilepsy. <img src = "http://goldrushcam.com/sierrasuntimes/images/2018/june/marijuana-cannibis-plant_0.jpg" alt = "marijuana cannibis plant 0 [19659002]" Everyone knew this was a good drug for seizures said Maria Roberta Cilio, MD, PhD, research director at the UCSF Pediatric Epilepsy Center, Cilio was the lead author of a multicentre study looking at the safety and efficacy of the new drug Epidiolex in children and young adults The study provided evidence that Epidiolex should be considered for FDA approval.

"UCSF was very brave to support me" Cilio said "We pioneered this drug . "

Eleven epilepsy centers across the country administered Epidiolex to 1

62 participants over 12 weeks, all of whom had severe, treatment-resistant childhood epilepsy 5 published in The Lancet Neurology showed that the treatment was well tolerated by the patients and the frequency of their seizures was reduced. Participants had an average 36.5 percent reduction in monthly motor seizures, which affects muscle activity, with the monthly incidence of motor seizures dropping from 30 a month to 15.8 during the course of the study.

Last Month of Study Six patients were free of all motor seizures and nine others were free of all seizure types. At the beginning of the study, some of these seizure-free patients regularly had hundreds of seizures per day and were treated in the emergency department every three weeks, said Cilio.

  Maria Roberta Cilio, MD, PhD (left) Maria Roberta Cilio, Ph.D.

Unclear how CBD works in seizures

Epidiolex is a purified form of cannabis without the main psychoactive component of the plant, tetrahydrocannabinol or THC. The liquid medication consists mainly of cannabidiol or CBD, a component of marijuana that produces anticonvulsant effects without accompanying "high".

It is still unclear what mechanism CBD relieves seizures, Cilio said, but basic research studies have consistently shown that while THC can sometimes cause seizures. Like any other antiepileptic drug, CBD oil works better in some patients than others and can sometimes be made more effective when combined with other medications. Now that Epidiolex is approved, further studies are needed to understand how it suppresses seizures at the molecular level and which patients could benefit most.

Currently, medical marijuana is licensed in 30 states and Washington DC. Syndros and Cesamet, which use synthetic forms of THC, but this is the first time a drug has been approved from the cannabis plant.

CBD oils containing varying levels of CBD and THC are already approved in some states. including Georgia, Iowa and Oklahoma, but only for the treatment of certain conditions and often only with an official registration card. The quality and dosage of these drugs has not been reviewed by the FDA.

In contrast, epidiolex has proven to be reliable and relatively safe over years of rigorous testing. It is now the only FDA-approved treatment for Dravet's Syndrome, a genetic disorder that can lead to daily seizures, sometimes hundreds. It is also approved for the Lennox-Gastaut syndrome, which is difficult to control with standard epilepsy drugs and therapies.

Children with Dravet's Syndrome begin to have seizures before their first birthday, and those with Lennox-Gastaut often show symptoms as infants. Epidiolex is now an option for these children and their families.

"I'm glad that this drug was finally approved – the first few years were not easy" Cilio said, referring to the regulatory hurdles of working with Schedule 1 classified substance. The next challenge is to better understand how the drug works, she said.

"This is just the beginning."


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