FDA experts have approved the first marijuana-based drug for patients with severe epilepsy. The tool may enter the American market in the fall of 2018.
The US Food and Drug Administration (FDA) has approved the use of a drug based on one of the cannabinoids found in hemp for the first time. Epidiolex reduces seizures in two rare and severe forms of epilepsy. The FDA's decision is reported on the organization's website.
Epidiolex is based on cannabidiol (CBD), one of the components of hemp. Unlike tetrahydrocannabinol (THC), cannabidiol is not psychoactive. The drug is made in the form of a strawberry-flavored syrup, you need to take it twice a day.
Epidiolex is designed to treat two severe forms of epilepsy - Dravet syndrome and Lennox-Gastaut syndrome. Both diseases are rare, they first appear in childhood: the first attack of Dravet syndrome in a child can occur at the age of several months. Diseases are accompanied by various types of seizures and loss of consciousness. Moreover, many modern antiepileptic drugs are ineffective for these diseases, so scientists are looking for new drugs.
Research in recent years has shown that CBD patients were less likely to experience seizures. FDA experts analyzed the results of three randomized, placebo-controlled trials of different CBD-based drugs in patients with severe epilepsy. The tests involved 516 people with Dravet and Lennox-Gastaut syndromes. Epidiolex markedly reduced the number of seizures, with drowsiness and decreased appetite being the most common side effects. The drug was allowed to be used in the treatment of children aged two years and older.
Epidiolex Packaging / AP Photo / Kathy Young.
According to representatives of the company that manufactures Epidiolex, the drug may go on sale in the US in the fall of 2018. European health experts can also approve the use of drugs for severe forms of epilepsy - the final decision will be made in the spring of 2019.
Natalia Pelezneva
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