United States: FDA approves Epidiolex, the first authorized cannabis-based medicine

The Food and Drug Administration (FDA), whose responsibilities include drug approval, yesterday approved the first cannabis-based medication in the United States. Epidiolex can be prescribed to treat two forms of epilepsy in children over the age of 2: Dravet and Lennox-Gastaut syndromes (LGS).

Both forms of epilepsy lead to frequent, life-threatening seizures, affecting both learning ability and intellectual and psychomotor development, and sometimes requiring emergency medical care.

«For people living with intractable seizures caused by LGS and Dravet syndrome, Epidiolex represents a real medical breakthrough,» said Philip Gattone, President of’Epilepsy Foundation.

«Clinical research around these rare and serious diseases is essential, and today's news brings hope for these patients and their families that a new treatment option could help them better control their seizures.»

Epidiolex is a strawberry-flavored syrup containing 98% of cannabidiol (CBD), one of the hundreds of molecules in cannabis, and less than 0.1% of THC.

The drug is manufactured by GW Pharmaceutical in the UK, where the company grows medical cannabis from which CBD is then extracted.

Its market launch now depends on the Drug Enforcement Agency which has 90 days to reclassify CBD, now categorized in Schedule 1 of the US narcotics list, a section that recognizes no therapeutic value for the substances present.

The effectiveness of Epidiolex was studied in three clinical trials randomized placebo-controlled trial involving 516 patients with Dravet or LGS. The drug proved effective in reducing seizure frequency. FDA advisory panel had given the green light in April for Epidiolex.