FDA approves first ever drug derived from marijuana

FDA approves first ever drug derived from marijuana | TheHill

Dravet syndrome is a rare genetic condition that usually shows up in infants, starting with fever-related seizures and progressing to other, more severe seizure types.

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

Given that CBD is an ingredient in marijuana, people often confuse it with taking "regular" marijuana. 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.

The drug contains nearly non of the psychoactive chemical from marijuana that makes people high and proved through testing to be effective in treatment of certain pediatric seizure patients. This might involve designing robust clinical trials, partnering with top university researchers, and presenting strong data - all of which GW Pharmaceuticals did in the years leading up to Epidiolex's recent green light. Unfortunately, as with most pharmaceutical drugs, we have all seen that no one drug can act as a panacea against such devastating conditions. The agency has previously approved drugs made from synthetic versions of THC and other marijuana constituents.

"This is an important medical advance", he said.

Several states have legalized CBD oil specifically for the treatment of intractable epilepsy or seizure disorders. At just 4 months old, he started having violent seizures.

Epidiolex is the name of the new drug that will come in a syrup form. "This new treatment provides new options for patients".

Epidiolex won't require a special certification to prescribe, Patel said, and it's likely physicians will prescribe it for off-label uses.

CBD oil is now sold online and in specialty shops across the USA, though its legal status remains murky.

The immediate impact of Monday's approval on these products is unclear. In April, an expert advisory panel for the FDA voted unanimously to recommend Epidiolex's approval and determined that "CBD has a negligible abuse potential". FDA Commissioner Scott Gottlieb further added: "This is the approval of one specific CBD medication for a specific use".

Most CBD producers sidestep the issue by making only broad claims about general health and well-being.

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

But Heather Jackson of Realm of Caring, a charity affiliated with the CBD company CW Hemp, tells the outlet, "I don't know a mom or dad in their right mind who is going to change what's already working". Some parents have used unapproved CBD oils to treat their children.

"There's a drug route and a pharmaceutical route and there's a dietary supplement route and we need to have both of those options available", said Jackson.

GW Pharmaceuticals, the British company responsible for the drug, said now approved AEDs (anti-epileptic drugs) are not always effective in the majority of patients with Lennox-Gastaut Syndrome (LGS) and Dravet syndrome - severe forms of childhood-onset epilepsy. GW Pharmaceuticals has monitored Epidiolex' effects on over 500 children and adults who are afflicted with seizure conditions that are hard to treat using traditional medications for epilepsy.

"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.

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

Before sales of Epidiolex can begin, the DEA must formally reclassify CBD into a different category of drugs that have federal medical approval.

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