First FDA-Approved Cannabis-Based Drug Now Available in the US
WASHINGTON -- Epidiolex, the first cannabis-based medication approved by the US Food and Drug Administration, is now available by prescription in all 50 states.
Epidiolex is a twice-daily oral solution of pure plant-derived cannabidiol, or CBD, according to manufacturer GW Pharmaceuticals.
It is approved for use in patients 2 and older for the treatment of two rare seizure disorders: Dravet syndrome, a rare dysfunction of the brain that appears in the first year of life, and Lennox-Gastaut syndrome, a form of epilepsy with multiple types of seizures that usually begins in early childhood.
"Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures," said Justin Gover, CEO of GW Pharmaceuticals, the maker of Epidiolex, in a written statement.
Epidiolex was recommended for approval by an advisory committee in April and approved by the FDA in June. It was classified as a Schedule V substance in September, clearing the final hurdle for it to be legally prescribed by US doctors.
GW Pharmaceuticals says the average list price of Epidiolex is $32,500 a year. The company expects that the drug will be covered by most insurance plans.
Although Epidiolex is approved only for the treatment of two rare seizure disorders, doctors can now prescribe the medication "off-label" for other conditions. According to the US Department of Health and Human Services, this is both legal and common; one in five of all medications prescribed is for off-label use.
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