This Is the First FDA-Approved Medicine Derived From Cannabis

This Is the First FDA-Approved Medicine Derived From Cannabis

Almost 70 percent of those products had different amounts of CBD than were specified on the product label, with many testing positive for the psychotropic THC even though the products are legally not supposed to have any THC.

As expected, the U.S. Food and Drug Administration on Monday approved GW Pharmaceuticals PLC-ADR (NASDAQ: GWPH)'s Epidiolex for the treatment of epilepsy, specifically for people who suffer with Lennox-Gastaut and Dravet syndromes.

The drug, administered as an oil, could significantly improve the quality of life for patients with two types of childhood epilepsy: Dravet syndrome, a genetic illness that kills up to 20 percent of sufferers before age 20, and Lennox-Gastaut syndrome, a form that begins between ages 3 and 5 and causes intellectual disability.

Most patients with LGS and Dravet syndrome require multiple seizure medications and the majority are resistant to now approved drugs. The drug will not bring about feelings of being "high" that comes from THC, but rather pull from CBD in the sativa plant that is commonly known as being used as medicine.

Epidiolex is based on cannabidiol, more commonly called CBD, rather than THC, which is the component associated with psychoactive effects.

An FDA advisory committee recommended approval of Epidiolex in April; it had until this week to make a decision on the recommendation.

Federal agencies have 90 days to determine the scheduling of Epidiolex.

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In 2013, the FDA gave GW Pharmaceuticals of the United Kingdom permission to use the cannabidiol-derived drug, in clinical trials. However, Schultz says his company plans to create more CBD medications.

He said the FDA would review legitimate applications for approval but said the agency needed solid scientific studies that demonstrate whether a product actually works and is safe. The FDA said Epidiolex was tested in three clinical trials involving 516 people with the syndromes and was found to be effective at reducing the frequency of seizures better than a placebo when taken in conjunction with other medications.

Gottlieb noted that the action was "not an approval of marijuana or all of its components" but rather of one specific CBD medication for a particular use.

Patients, parents of children suffering from severe epilepsy, and some researchers have long suspected CBD's potential to treat the devastating seizure disorders. It also marks a landmark moment in the agency's advancement in considering cannabis for medical purposes. "However, it remains to be seen whether physicians will be comfortable prescribing this new agent to those patients who may benefit from it, and whether it will be priced in a range that patients may afford".

It's not clear how quickly the drug will be available for prescription. But six years ago, she started giving him oil, potent with CBD, made from a strain of marijuana grown in Teller County by the Stanley brothers.

The US Food and Drug Administration announced today, Monday June 25, the approval of the country's first marijuana-based prescription medication. Epidiolex contains CBD, a cannabis chemical compound skyrocketing in popularity and driving what is estimated to have doubled into a $200 million market in 2018.

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