FDA Approves First Marijuana-Based Drug for Epilepsy Patients

FDA approves first ever drug derived from marijuana | TheHill

FDA Approves First Drug Derived From Marijuana Plant

She is Dr. Elaine Wirrell, not Ellaine.

But it's not quite medical marijuana. CBD does not contain THC, the psychoactive ingredient in marijuana, so it can not get patients high. It's not yet clear why the ingredient, known as CBD, reduces seizures in some people.

It was observed that in combination with other medications, Epidiolex reduced the frequency of seizures as compared to placebos.

Earlier today, FDA Commissioner Scott Gottlieb made similar observations in a prepared statement.

Patients age 2 and up will be able to use the drug.

The two epilepsy forms are severe and associated with high rates of mortality.

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CBD is different from marijuana's more well-known compound: tetrahydrocannabinol, or THC, which gets people high.

Gottlieb went on to say that the FDA will support further scientific studies involving the therapeutic potential of marijuana-derived products. Despite that they are still classed as schedule one, making them all illegal on the federal level, causing much confusion.

Side effects with the drug include diarrhea, vomiting, fatigue and sleep problems.

Austin resident Terri Carriker said the drug has improved her 15-year-old daughter's life. But then Hendershot learned about a trial of Epidiolex at New York University. Some LGS patients have to wear helmets to avoid brain injuries from "drop seizures", where muscles suddenly become limp and cause standing patients to collapse. However, the legal status of these products is uncertain, as is their quality.

While there is no clear answer, most legal experts agree on the "source theory" that if the plant is legal, the products derived from it are legal.

This one landmark approval could have another one following it soon: the reclassification of CBD by the United States Drug Enforcement Administration.

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Previous studies reported that CBD can efficiently treat medical conditions such as autism, anxiety, depression, and cancer.

The FDA's approval, and the subsequent expectation that CBD will be rescheduled by the DEA, is good news for the fledgling cannabis industry. "We're just now really understanding cannabinoids and the breadth of what they can do". He described it as the 'first and only FDA-approved cannabidiol medicine to treat two severe, childhood-onset epilepsies'. A milestone for the medical cannabis community, news of the approval sent GW's prices skyrocketing, with the company closing the day up 1.21 percent, and up a whopping 6.34 percent in after-hours trading.

"These don't have to be huge trials, because Angelman syndrome is a rare disease", Bichell said, "but it would still be important to know definitively if this is the right drug for AS".

But doctors will have the option to prescribe it for other uses. In November 2016, 4 more North American States - California, Massachusetts, Nevada and ME - voted for the legalization of marijuana for recreational purposes. Another 20 states allow medical marijuana, but the US government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.

So yeah, a blanket reclassification of marijuana looks unlikely, at least in the near future. A year ago a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health. The agency is expected to do so within 90 days. Lawyers interpret this to mean that CBD derived from hemp grown domestically within the US under the 2014 Farm Bill regulations is legal.

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