• News
  • Health Care

FDA approves first ever drug derived from marijuana

On June 25, the US Food and Drug Administration (FDA) approved the first drug based on compounds found in marijuana.

A new drug derived from marijuana just became the first of its kind to get the green light from the USA government.

Now that Epidiolex is approved by the FDA, cannabidiol will probably be reclassified by the Drug Enforcement Administration within 90 days.

The component in this newly approved drug is CBD (cannabidiol), which is part of the sativa marijuana plant. That so-called "high" comes from a different compound in marijuana, known as tetrahydrocannabinol (THC).

Many families have moved to states where marijuana is legal medically or recreationally so they could treat their children with CBD on their own.

The twice-daily oral solution is approved for use in patients 2 and older to treat two types of epileptic syndromes: Dravet syndrome, a rare genetic dysfunction of the brain that begins in the first year of life, and Lennox-Gastaut syndrome, a form of epilepsy with multiple types of seizures that begin in early childhood, usually between 3 and 5. "And, the FDA is committed to this kind of careful scientific research and drug development", FDA Commissioner Scott Gottlieb, M.D, said. Researchers and advocates cautioned against this, however, with the caveat that it's impossible to verify that what's in those products is actually pharmaceutical-grade CBD.

Epidiolex is under review in Europe as well, and GW expects a decision from the European Medicines Agency in the first quarter of next year.

The FDA has approved synthetic versions of some cannabinoid chemicals found in the marijuana plant for other purposes, including cancer pain relief.

"In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD", Devinsky said.

Although several states have legalized the medical and recreational use of marijuana, the federal agency had yet to do so until today.

"The DEA will not prevent Epidiolex from being sold", Fox said Monday.

"I'm really happy we have a product that will be much cleaner and one that I know what it is", Wirrell told the Associated Press.

"The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", Gottlieb said.

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. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions. "Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery".

Across the board, the drug was shown to be effective in cutting the frequency of seizures.

The FDA's decision was expected. And the company plans to continue importing the medicine, bypassing onerous US regulations on manufacturing restricted substances.

Leave Your Comment

Leave Your Comment

Latest News

Breaking News


South Korea v Mexico pic special

Ki suffered a left calf injury during the match against Mexico and will not be available for South Korea's duel against Germany. Coach Juan Carlos Osorio insisted that his team would not be complacent, however, underlining South Korea's tactical nous.

Iconic Performances & Moments You Missed At The 2018 BET Awards

At the 2018 BET Awards , she chose to tone things down, opting for a midi-length dress with a flattering sweetheart neckline. Beyonce, who won the award for the best female R&B/pop artist, and Cardi B, who got the best female hip hop artist award.

Pompeo says no timeline on North Korea negotiations

North Korea is expected to be among the top items on Mattis' agenda during his talks with senior Chinese officials. Many observances took place in South Korea involving officials including South Korean President Moon Jae-in.

Selfies show worm slithered through woman’s face for 2 weeks ars_ab.settitle(1335881)

But humans can become accidental hosts of the thread-like worm - meaning the worm doesn't intend to infect a human. This organism usually finds it hard for breeding when human beings become the host through mosquito bites.


Brazil's talisman wept after the final whistle - the win relief both for him and for his nation. Brazil will next lock horns with Serbia at Spartak Stadium in Moscow on June 27.

New AirPods, Apple noise-cancelling headphones pegged for 2019

You won't be swimming in them though: The water resistance is mainly to protect against rain and perspiration , the people said. For the deluxe AirPods and the new HomePod, Apple will reportedly work with Foxconn as part of an expanded alliance.

Erdogan Wins Another Term as Turkey's President

He added: "I hope nobody will damage democracy by casting a shadow on this election and its results to hide their failure". Erdogan responds to such criticism by saying he is trying to modernise Turkey and improve religious freedoms.

Xhaka and Shaqiri score for Swiss, make Albanian symbol

Xhaka , whose 52rd-minute piledriver set up the Swiss comeback, also made the "double eagle" gesture after his goal. When asked about his celebration Shaqiri said, 'It's just emotion .

Thousands flee as winds fan growing California wildfires

The Bascom Fire in Shasta County had burned about 328 acres and was 85 percent contained as of Sunday night. Officials are now battling the following fires and ordered evacuations for the following areas.

Authorities: 7 arrests in connection with fatal stabbing

Cheers rang out outside a makeshift memorial for the teen at the bodega Sunday on the news of the arrests, the station reports. Guzman-Feliz was a member of the NYPD's Explorers program , a group for youths interested in a law enforcement career.