The U.S. Food and Drug Administration (FDA) has approved Epidiolex to treat Dravet and Lennox-Gastaut syndromes, making history as the first approved therapy for Dravet, as well as the first marijuana-derived treatment to receive FDA approval for any indication.
The move marks several firsts. Insys is developing a cannabidiol oral solution for a severe type of epileptic seizure known as infantile spasms, and childhood epilepsy defined by staring spells where the child isn't aware or responsive.
Two months after a unanimous recommendation by an outside group of FDA experts and some glowing recommendations in the internal review, GW will now set out to open up a new class of meds after demonstrating the drug's ability to prevent seizures in children suffering from rare cases of Lennox-Gastaut syndrome and Dravet syndrome.
He added: "These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician's care".
In a study involving children with Dravet syndrome, five percent became seizure free while taking the drug compared to none in the placebo arm, and patients also had a significantly greater median reduction in convulsive seizures (39 percent) compared to placebo (13 percent). Although a synthetic version of THC, marijuana's main psychoactive ingredient, has been legally available as a treatment for nausea and appetite loss since 1985, this is the first time the federal government has given its blessing to a medication derived directly from cannabis.
"For those living with intractable seizures caused by LGS and Dravet syndrome, Epidiolex represents a true medical advancement", said Philip Gattone, president and CEO of the Epilepsy Foundation.
There are side effects, the most common being sleepiness, Gover said.
50 children in the United Kingdom have been given Epidiolex as a treatment as part of a large scale clinical trial that took in 1,500 kids worldwide. And Epidiolex could well be the first in a wave of marijuana-based therapies; agency officials said they have implemented regulatory processes to help drug developers test marijuana or its components in their own clinical trials. 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.
And Epidiolex's approval doesn't mean other CBD substances are OK to sell, Gottlieb said.
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