What is epidiolex fda approved for?

EPIDIOLEX is the first and only prescription cannabidiol (CBD) approved by the FDA to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or the tuberous sclerosis complex (TSC) in patients aged 1 year and older. The. gov means it's official, federal government websites often end in.gov or. thousand.

Before sharing sensitive information, make sure you're on a federal government site. CBD is a chemical component of the plant Cannabis sativa, more commonly known as marijuana. However, CBD doesn't cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). The main psychoactive component of marijuana is THC (and not CBD).

Dravet syndrome is a rare genetic condition that occurs during the first year of life with frequent seizures related to fever (febrile seizures). Later on, other types of seizures usually arise, including myoclonic seizures (involuntary muscle spasms). In addition, a state epileptic may occur, a life-threatening state of ongoing seizure activity that requires emergency medical attention. Children with Dravet syndrome often experience poor motor and language skills development, hyperactivity, and difficulty relating to others.

The efficacy of Epidiolex was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken together with other medications, was shown to be effective in reducing the frequency of seizures compared to placebo. Under the Controlled Substances Act (CSA), CBD is currently a Schedule I substance because it is a chemical component of the cannabis plant. In support of this application, the company conducted clinical and non-clinical studies to assess the potential for abuse of CBD.

The FDA prepares and transmits, through the U.S. Department of Health and Human Services, a medical and scientific analysis of substances subject to classification, such as CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the CSA. The DEA must make a programming determination. The FDA granted the Priority Review designation for this request.

The FastTrack designation was granted for Dravet syndrome. The designation of an orphan drug was granted for the indications of Dravet syndrome and Lennox-Gastaut syndrome. The FDA granted Epidiolex approval to GW Research Ltd. The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety of human and veterinary drugs, vaccines and other biological products for human and veterinary use, and medical devices.

The agency is also responsible for the security of our country's food supply, cosmetics, dietary supplements, products that emit electronic radiation, and for regulating tobacco products.

Mariah Wisley
Mariah Wisley

Award-winning music specialist. Freelance food maven. Freelance internet guru. Unapologetic zombie geek. Certified pop culture advocate. Infuriatingly humble introvert.

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