FDA Moves Forward With Marijuana-Based Drug To Fight Childhood Epilepsy

marijuanaindex.com

The Food and Drug Administration has granted orphan drug designation for a cannabis-based drug developed to treat childhood-onset epilepsy, GW Pharmaceuticals announced last week.

Although not full FDA approval — its maker still must demonstrate the efficacy of the drug in clinical trials — the orphan drug designation represents a tremendous step forward for cannabis-based medicine.

The drug, called Epidiolex, contains a highly purified, plant-derived form of cannabidiol (CBD), a non-psychoactive compound found in marijuana that doesn’t produce the “high” sensation associated with THC, the plant’s main psychoactive ingredient. CBD has long been used as a treatment for Dravet syndrome, a rare and severe form of epilepsy in children, and GW Pharmaceuticals sees Epidiolex as useful in treating both Dravet and Lennox-Gastaut syndrome (LGS), another rare form of childhood epilepsy.

The FDA grants the orphan drug designation to drugs intended to treat rare disorders. It qualifies the maker of the drug for certain tax incentives related to clinical testing as well as an exclusive marketing period for the drug.

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