FDA Approves First Drug From Marijuana Plant

Norman Posselt—Getty Images  fStop

Norman Posselt—Getty Images fStop

LGS and Dravet syndrome, which develop in childhood, are rare, severe forms of epilepsy that are notoriously treatment-resistant.

A mother feeds her epileptic son, whom she treats with medical marijuana, in Siedlce, Poland, in October 2017.

A phase three clinical trial is underway for a third seizure-related condition called tuberous sclerosis complex, which begins in infancy and causes a sudden stiffening of the body, arms and legs, with the head bent forward. The drug is designed for people age 2 and older. CBD is one of more than 100 chemicals found in marijuana.

Gottlieb also used the approval to vouch for the years-long clinical development of Epidiolex as a model for bringing products made from marijuana to the market.

Shlomo Shinnar, president of the American Epilepsy Society and a neurologist at Montefiore Medical Center in NY, has said the drug will be "a very valuable addition" to the limited options for treating severe childhood-onset epilepsy.

The FDA cites a number of side effects associated with Epidiolex that may give some patients pause, however, including the potential for increased liver enzymes, weakness, poor sleep quality, and diarrhea, among others. In some cases, patients have moved to states that have legalized medical marijuana in order to have access to the drug.

Epidiolex is the name of the new drug that will come in a syrup form.

Carson says he will likely prescribe Epidiolex going forward. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.

The immediate impact of Monday's approval on these products is unclear. The FDA has previously sent warning letters to companies that hyped their products as cancer or Alzheimer's fighters.

The U.S. approval for Epidiolex was largely expected after an FDA advisory panel endorsed it with a 13-0 vote in April.

DENVER ― Medical marijuana now comes with the FDA seal of approval.

Parents treated their children's seizures with CBD oil years before the FDA backed any drug. The pharmaceutical manufacturer behind the drug, GW Pharmaceuticals, is negotiating prices with health insurance companies. From Walmart to CVS to the Mom-n-Pop drugstores still kicking it Smalltown, USA - legitimate cannabis medicine will be available in the same way as other prescription drugs. Though other drugs are approved to treat Lennox-Gastaut syndrome, Epidiolex is the first licensed to treat Dravet syndrome.

Despite increasing acceptance, there is little rigorous research on the benefits and harms of marijuana.

GW Pharma won't be able to launch the drug right away, however, because its active ingredient, CBD, needs to be rescheduled by the DEA. That decision is expected within 90 days.

Cannabidiol (CBD) is the first FDA-approved drug derived from marijuana and the first FDA-approved drug to treat patients with Dravet syndrome. And the company plans to continue importing the medicine, bypassing onerous US regulations on manufacturing restricted substances. "This is how sound medical science is advanced".

This story has been corrected to reflect that Realm of Caring is not affiliated with the Colorado-based company CW Hemp.

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