EPIDIOLEX is the only prescription drug with CBD approved by the FDA, which, among many things, means that it has a safety and efficacy profile that has been thoroughly evaluated in clinical trials. 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 Cannabis sativa plant, better known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). THC (not CBD) is the main psychoactive component of marijuana.
Dravet syndrome is a rare genetic condition that occurs during the first year of life with frequent fever-related seizures (febrile seizures). Later on, other types of seizures usually occur, such as myoclonic seizures (involuntary muscle spasms). In addition, there may be status epileptic, a state of continuous seizure activity that can be life-threatening and that requires emergency medical attention. Children with Dravet syndrome often have poor language and motor skill development, hyperactivity, and difficulty relating to others.
The effectiveness 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, has been 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 request, the company conducted clinical and non-clinical studies to assess the abuse potential of CBD.
The FDA prepares and transmits, through the United States 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) on controls under the CSA. The DEA must make a determination about programming. The FDA granted the priority review designation for this application. The Fast-Track designation was granted for Dravet syndrome.
The orphan drug designation was granted for both Dravet syndrome and Lennox-Gastaut syndrome indications. The FDA granted the approval of Epidiolex 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 and effectiveness of drugs, vaccines and other biological products for human and veterinary use and medical devices. The agency is also responsible for the safety of our country's food supply, cosmetics, dietary supplements and products that emit electronic radiation and for regulating tobacco products.
Currently, the only plant-based drug approved by the FDA that contains CBD is Epidiolex, produced by GW Pharmaceuticals. Epidiolex treats two rare forms of epilepsy in children over two years old: Lennox-Gastaut syndrome and Dravet syndrome. CBD is a part of the cannabis plant that doesn't cause the high associated with marijuana use. Some research has found that it can relieve pain, and the FDA has approved a CBD drug to treat rare and severe forms of epilepsy.