First Marijuana-Based Drug Approved to Treat LGS, Dravet Syndrome

FDA approves first ever drug derived from marijuana | TheHill

Regulators at the US Food and Drug Administration on Monday granted market approval for Epidiolex, a prescription medicine containing a standardized formulation of plant-derived cannabidiol (CBD), for the explicit treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

The approved drug is called Epidiolex. The medicine is now approved in the USA for treatment of seizures due to Lennox-Gastaut and Dravet syndromes, which are both severe forms of epilepsy. Therefore, patients will not be able to access Epidiolex until CBD is rescheduled by the DEA, which is expected to take place within 90 days, according to GW Research Ltd. Epidiolex is the first cannabis-based drug to be legalized in the United States.

This bit of marijuana news marks the first time in the history of the USA that the FDA has given its approval to a purified drug derived from marijuana. The new approval is already ushering in a wave of renewed interest in the potential health benefits of marijuana's many compounds, from CBD to THC - the plant's other well-known ingredient and the one linked with a high. Dravet syndrome is a rare genetic dysfunction of the brain in kids as young as one-year-old.

FDA commissioner Scott Gottlieb said the drug was an "important medical advance" but cautioned that approval did not cover medicinal cannabis, which is legal in some U.S. states but not in others. CBD does not contain THC, the psychoactive ingredient in marijuana, so it can not get patients high. CBD oil has gained popularity with consumers as a remedy for a variety of other ailments.

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CBD is effective in treating two different types of epilepsy, LGS and Dravet Syndrome, which can cause seizures and other symptoms. FDA staff said at an April meeting on the drug with outside advisers that cannibidiol, known as CBD, "does not appear to have abuse potential". The FDA noted in its announcement today that it informs and advises the DEA about scheduled substances.

With the historic approval, the London-based company behind the drug, GW Pharmaceuticals plc, is expecting another consequential decision in the coming weeks: getting the US Drug Enforcement Administration to reclassify CBD. The FDA's warnings reminded these producers that only FDA-approved products that have gone through rigorous clinical trials can make such claims.

Justin Gover, CEO of GW Pharmaceuticals, the UK-based company behind the drug, said the approval signals "validation of the science of cannabinoid medication".

Analysts claim that the drug launched by the pharmaceutical company may garner over Dollars 1 billion in annual sales, becoming GW's debut "blockbuster medication". "In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition".

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