The U.S. health regulator approved GW Pharmaceuticals Plc's epilepsy treatment on Monday, making it the first cannabis-based drug to win approval in the country and opening floodgates for more research into the medicinal properties of cannabis. Marijuana and its components, including CBD, are Schedule 1 controlled substances - meaning they are banned because they are thought to have a high abuse potential, no medical value and serious safety implications.
Commenting on the agency's decision, NORML Deputy Director Paul Armentano said: "The FDA's approval of this plant-derived medicine provides an additional option to patients seeking the therapeutic benefits of cannabis".
Epidiolex, developed by London-based GW Pharmaceuticals, is an oral solution containing "highly purified" cannabidiol (CBD).
For medical marijuana advocates, it's a clear vindication of a fundamental premise of a decadeslong movement: that cannabis can have legitimate medical applications and it isn't the bogeyman that the federal government has long made it out to be. This is the first time the agency has approved a medication with an active ingredient that comes from marijuana. However, Epidiolex does not contain THC, the component of marijuana that gets people high, Jamie Alan, an assistant professor of pharmacology and toxicology at Michigan State University, tells Yahoo Lifestyle.
GW CEO Justin Gover said: "This approval is the culmination of GW's many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine".
A new drug derived from marijuana just became the first of its kind to get the green light from the USA government.
Lennox-Gaustaut syndrome is estimated to account for between one and four percent of all cases of childhood epilepsy.
The FDA approval for Epidiolex is technically limited to patients with Dravet and Lennox-Gastaut syndromes, two rare forms of epilepsy for which there are few effective treatments.
"The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients' quality of life", said the FDA's Dr. Billy Dunn.
The EPIDIOLEX® clinical development program included three randomized, controlled Phase 3 clinical trials and an open-label extension study. And, as NPR has reported, CBD supplements are available widely online and in dispensaries in the form of oils or tinctures. The approval is expected to spur additional research into cannabis, which is still illegal under federal law.
He added, "This is how sound medical science is advanced".
Azadian is also planning to seek FDA approval for some of his company's CBD products, which it plans to sell in the US. "It's being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits", Gottlieb said. The drug will be marketed under the brand name Epidiolex.
"This is really a landmark for people with epilepsy in the United States".
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