FDA approves first marijuana-based drug

Epidiolex a medicine made from the marijuana plant but without THC

FDA approves first ever drug derived from marijuana | TheHill

It will treat lennox-gastaut, and another form of epilepsy called dravet syndrome.

Although THC can induce paranoia, anxiety and hallucinations, CBD has the opposite effect and has been cited by scientists as a potential treatment for mental health issues.

"The FDA will continue to support rigorous scientific research on potential medical treatments using marijuana and its components that seek to be developed through the appropriate scientific channels", FDA Commissioner Scott Gottlieb said in a Monday press release. After considerable public pressure, the Home Secretary used an "exceptional power" to enable a 12-year-old boy to be treated with a batch of a banned drug that had been seized from the boy's mother on her return from Canada to the UK. Epidiolex contains less than 0.1% of THC. Sativex hasn't been granted approval in the United States, however.

Even though 16 percent of trial participants experienced unwelcome side effects, such as diarrhea, vomiting and abnormal liver function, FDA officials and an advisory panel unanimously recommended its approval. In some cases, patients have moved to states that have legalized medical marijuana in order to have access to the drug.

That could accelerate the process of outlawing or allowing new drugs as they pop up.

Since receiving Epidiolex, Hendershot says her daughter has been able to concentrate more and has had fewer "drop" seizures - in which her entire body goes limp and collapses. However, the legal status of these products is uncertain, as is their quality. As well, CBD remains in a legal grey area, making it hard for patients outside of legal states to acquire.

The immediate impact of Monday's approval on these products is unclear. The FDA is willing to help companies that want to pursue such research programs, he said, but they need to prove their products work and are safe with data from clinical trials.

Furious Maradona wants meeting with Argentina squad
"These days, Cristiano Ronaldo has a very different role for Portugal", he told BBC Sport . The tiebreaker is goal difference, and Iceland leads Argentina minus-2 to minus-3.

Gover said the approval signals "validation of the science of cannabinoid medication".

The FDA seal is nonetheless seen to be a boon for the broader industry.

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".

The drug should provide a more reliable alternative than the homemade cannabis oil parents for years have made for the children, said Devinsky, who once treated Vivian Wilson of Scotch Plains, a toddler with Dravet syndrome.

With Epidiolex meeting FDA standards, the drug will "finally be made available to the thousands that may benefit from it", he said. Wall Street analysts have previously predicted it could cost $25,000 per year, with annual sales eventually reaching $1 billion.

The medication, which will continue to be manufactured in Britain, will be marketed by Greenwich Biosciences, the USA subsidiary of GW Pharmaceuticals.

The FDA says this is the first drug approved in the US that contains a purified substance derived from marijuana. Both cause uncontrolled daily seizures and put patients at high risk for other physical and intellectual disabilities, injury and early death.

Latest News