[ad_1]
June 30, 2018 – By Nicoletta Lanese – For the first time, a drug derived from marijuana has been approved by the Food and Drug Administration, and it may soon offer relief to children with problems health. Trauma. In 2013, UCSF Benioff Children's Hospital San Francisco became the first site to administer the drug to a child, and as of this week, the FDA approved its use in two rare forms of epilepsy and devastating <img src = "http://goldrushcam.com/sierrasuntimes/images/2018/june/marijuana-cannibis-plant_0.jpg" alt = "marijuana cannibis plant 0 [19659002]" Everyone knew that this could be a good medication for seizures, but no one has yet tried, " said Maria Roberta Cilio, MD, PhD, director of research at the UCSF Pediatric Epilepsy Center. Lead author of a multi-center study evaluating the safety and efficacy of the new drug, Epidiolex, in children and young adults. </ p> <p> The study provided evidence that Epidiolex should be considered for the approval of the FDA.
"The UCSF was very brave for me outgoing, " Cilio said. "We were the pioneers of this drug."
Eleven centers of epilepsy across the country administered Epidiolex to 162 participants for 12 weeks. All participants had severe, early, treatment-resistant epilepsy. The results, published in The Lancet Neurology in 2015, showed that the treatment was well tolerated by patients and reduced the frequency of their seizures. Participants had a median reduction of 36.5% in monthly motor seizures that affected muscle activity, with the monthly median frequency of motor seizures increasing from 30 to 15.8 during the trial. six patients were free of all motor seizures and nine were free of all types of seizures. At the start of the study, some of these crisis-free patients routinely had hundreds of seizures a day and ended up in the emergency department every three weeks or so, Cilio says.
(Left) Maria Roberta Cilio, MD, Ph.D.
It is not known how CBD acts on epileptic seizures
Epidiolex is a purified form of cannabis devoid of the main psychoactive component of the plant, tetrahydrocannabinol or THC. The liquid medicine is mainly composed of cannabidiol, or CBD, a component of marijuana that produces anticonvulsant effects without "accompaniment".
The mechanism by which CBD attenuates seizures is still unclear, but baseline studies have demonstrated that is the case, while THC can sometimes cause seizures. Like any other antiepileptic drug, CBD oil works better for some patients than others and can sometimes be made more effective if it is combined with other drugs. Now that Epidiolex is approved, further studies are needed to understand how it stifles seizures at the molecular level and which patients could benefit the most.
Currently medical marijuana is legal in 30 states and Washington DC The FDA has already approved the drugs Marinol, Syndros, and Cesamet, which use synthetic forms of THC, but this is the first time that 's. a drug derived from the cannabis plant is approved.
CBD oils containing different percentages of CBD and THC are already legal for medical use in some states, including Georgia, Iowa, and Oklahoma, but only for the treatment of specific conditions and often only with an official registration card. The quality and dosage of these drugs have not been verified by the FDA.
By contrast, Epidiolex has proven reliable and relatively safe after years of rigorous testing. It is now the only FDA approved treatment for Dravet syndrome, a genetic disorder that can cause daily seizures, sometimes by the hundreds. It is also approved for Lennox-Gastaut syndrome, which is difficult to control with standard drugs and therapies for epilepsy.
Children with Dravet syndrome begin to have seizures before their first birthday, and those with Lennox-Gastaut often begin to show symptoms. Epidiolex is now an option for these children and their families.
"I am happy that this drug was finally approved – the early years were not easy," Cilio said, referring to the regulatory hurdles of working with a ranked substance in the US. Annex 1. The next challenge will be to better understand the mechanism of action of the drug, she said.
"This is only the beginning."
Source link
