FDA approves first cannabis-based drug

FDA approves first ever drug derived from marijuana | TheHill

Regulators at the US Food and Drug Administration today 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 component in this newly approved drug is CBD (cannabidiol), which is part of the sativa marijuana plant.

Dravet syndrome is a rare genetic condition that causes frequent fever-related seizures, involuntary muscle spasms and a potentially life-threatening state of continuous seizure activity requiring emergency medical care. Epidiolex, which is produced by the United Kingdom-based company GW Pharmaceuticals, is meant to treat two forms of rare childhood epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. FDA officials also said the drug doesn't appear to have abuse potential, citing minimal reports of euphoria in patients who took the drug in clinical studies. Carreno says that once the drug is descheduled, CBD manufacturers must register with the DEA-and that will make all the difference to the industry in the U.S.

"This is an important medical advance", FDA Commissioner Scott Gottlieb, MD, said in a statement. "This is how sound medical science is advanced". "This is the approval of one specific CBD medication for a specific use", Gottlieb said.

"I hope patients have conversations with their physicians about whether this product (Epidiolex) provides them with treatment they have been looking for with other unapproved products", said Douglas Throckmorton, deputy director of regulatory programs at the FDA's Center for Drug Evaluation and Research. There are only a few pharmaceutical treatments for patients living with Lennox-Gastaut, no pharmaceutical options for those living with Dravet syndrome. "We'll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high-quality products".

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Epidiolex is also the first prescription created to treat children with Dravet syndrome, according to the FDA's announcement.

As a result, Epidiolex's launch remains at the discretion of the DEA which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, which would allow GW to begin selling it. Schedule I drugs include heroin and LSD as well as marijuana. Once the FDA approves Epidiolex, the DEA will be compelled to deschedule it from a Schedule I drug on the Controlled Substances Act (defined as "no recognized medical use") to either a Schedule II or III drug.

The two epilepsy forms are severe and associated with high rates of mortality.

In April, an advisory committee to the FDA voted unanimously that the risk-benefit profile for Epidiolex was favorable. That so-called "high" comes from a different compound in marijuana, known as tetrahydrocannabinol (THC). Another 20 states allow medical marijuana, but the US government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.

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