FDA Approves First Drug From Marijuana Plant


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.

It's an option for those patients who have not responded to other treatments to control seizures. FDA officials said the drug reduced seizures when combined with older epilepsy drugs.

The drug, Epidiolex, is made up of cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant, and contains less than 0.1 percent of tetrahydrocannabinol (THC), the psychoactive component that makes people high.

Epidiolex is under review in Europe as well, and GW expects a decision from the European Medicines Agency in the first quarter of next year.

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"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. However, access to a cannabinoid-medicine like Epidiolex could substantially reduce seizure frequency.

There are likely to be drug interactions, she said, but "that's not uncommon for antiepileptic medications", and she noted that this could affect the effectiveness of the medication. The oral drug Epidiolex is intended for patients to treat two rare, and severe forms of epilepsy-Lennox-Gastaut syndrome and Dravet syndrome. Past year a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health. But then Hendershot learned about a trial of Epidiolex at New York University.

The FDA has previously approved synthetic medications that resemble or are identical to THC.

"For a maligned substance like cannabis, I think the vindication tour will ultimately be years long", said Ricardo Baca, a former marijuana editor at the Denver Post, and the founder of Grasslands, a cannabis PR agency.

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Many families have moved to states where marijuana is legal medically or recreationally so they could treat their children with CBD on their own.

FDA said it is providing medical and scientific information and recommendations to the DEA about CBD.

Physicians say it's important to have a consistent, government-regulated version. "But it's also important to note that this is not an approval of marijuana or all of its components". FDA Commissioner Scott Gottlieb further added: "This is the approval of one specific CBD medication for a specific use". And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. And, as NPR has reported, CBD supplements are available widely online and in dispensaries in the form of oils or tinctures. 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. Rescheduling cannabidiol paves the way for other advanced cannabinoid formulations, like the ones now being researched and developed by scientists on staff at my Colorado-based cannabinoid science business, ebbu. The agency will continue to crack down on companies selling the compound for unproven medical claims.

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