The DEA did not immediately respond to Ars' request for comment.
Patients with Lennox-Gastaut and Dravet syndromes, which typically emerge in the first few years of life, can suffer from debilitating and recurrent seizures, sometimes dozens a day. "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", said Justin Gover, the pharmaceutical company's CEO, in a press release. The DEA's decision is expected to be made within 90 days.
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Anup Patel, M.D., chair of the LGS Foundation's professional advisory board, chief of neurology at Nationwide Children's Hospital and study investigator, says, "I am very pleased to see the FDA's approval of EPIDIOLEX® for LGS and Dravet syndromes".
Marijuana has always been known to be effective in reducing the frequency of seizures in some patients; and many patients buy medical grade marijuana in states where it is legal as treatment.
Epidiolex is a strawberry syrup that has been infused with CBD, one of the active ingredients in marijuana, and can be used as a treatment for several forms of epilepsy. There was some concern about the drug's effects on the liver, but experts have said this risk could be addressed by doctors as they monitor their patients during treatment.
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"I hope patients have conversations with their physicians about whether this product (Epidiolex) provides them with treatment they have been looking for with other unapproved products", said Douglas Throckmorton, deputy director of regulatory programs at the FDA's Center for Drug Evaluation and Research.
"But it's also important to note that this is not an approval of marijuana or all of its components", said FDA Commissioner Scott Gottlieb.
We'll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high-quality products.
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The FDA also stated that if illegal CBD products make serious, unproven medical claims, then it will take action. "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 first is Dravet syndrome, which is a rare genetic dysfunction that starts within a child's first year, and the second is Lennox-Gastaut syndrome, which is a form of epilepsy that causes multiple types of seizures usually starting from 3 to 5 years old.