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United States Food and Drug Administration approved the use of a drug derived from marijuana for the first time Monday, giving the opportunity to treat two rare forms of epilepsy with the compound cannabidiol, also known as CBD, found in hemp and marijuana.
Epidiolex, a form of cannabidiol, will be legally used to treat Lennox-Gastaut syndrome and Dravet syndrome, two serious and rare forms of epilepsy. Epidiolex is the first approved treatment for Dravet syndrome, according to the FDA.
Although CBD is extracted from sativa marijuana plants, it does not produce the level typically associated with marijuana because it does not contain the THC psychoactive ingredient. Instead, CBD is often used in the form of oil as a way to relieve anxiety without the top.
"This endorsement serves as a reminder that promoting strong development programs that properly value active ingredients in marijuana can lead to important medical therapies," said FDA Commissioner Scott Gottlieb in a statement. .
Epidiolex was effective in reducing the frequency of seizures in patients with both syndromes in clinical trials. Since Lennox-Gastaut syndrome and the Dravet synonym occur early in childhood, Epidiolex is legal in the treatment of patients two years of age and older.
Both syndromes have uncontrollable and severe seizures resulting in some form of learning disorder, such as language and motor disorders.
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For families whose loved ones are suffering from these epileptic disorders, the approval of Epidiolex offers "much needed hope," said Christina SanInocencio, executive director of the LGS Foundation, in a statement. But even with CBD oil, most people with LGS "will continue to have debilitating seizures for life," she added.
Some side effects presented in clinical trials include drowsiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, weakness, insomnia, poor sleep and infections, according to the FDA.
CBD is currently considered an Schedule I drug because of its relationship with marijuana. Trials have been conducted to examine the potential for CBD abuse.
According to the CBD summit, the CBD industry is worth $ 200 million. The use of CBD in the treatment of other diseases and disorders, such as post-traumatic stress disorder, is being tested.
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