With CBD, marijuana-based medicine gets its first greenlight from the FDA

With CBD, marijuana-based medicine gets its first greenlight from the FDA

USA health regulators on Monday approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use. However, it isn't clear whether such a reclassification would involve CBD products in general, the CBD formulation used specifically in Epidiolex or something else. The FDA has approved the first medication containing marijuana for patients with rare forms of epilepsy. It does not contain THC, the well-known psychoactive component of marijuana responsible for the drug's characteristic high. Epidiolex, which is produced by the United Kingdom-based company GW Pharmaceuticals, is meant to treat two forms of rare childhood epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. Scott Gottlieb stressed in a statement that approval of the drug wasn't a co-sign for marijuana, but just for "one specific CBD medication for a specific use".

Side effects with the drug include diarrhea, vomiting, fatigue and sleep problems.

The FDA previously cracked down on CBD companies for claiming their products could treat cancer and other conditions. Carreno says that once the drug is descheduled, CBD manufacturers must register with the DEA-and that will make all the difference to the industry in the U.S.

The FDA is not required to follow the advisory panel's advice but usually does.

Figi's daughter, Charlotte, was the first to use the Colorado CBD.


"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. There was some concern about the drug's effects on the liver, but experts have said this risk could be addressed by doctors as they monitor their patients during treatment.

GW Pharma grows its own supply of cannabis in specialized glass houses in the United Kingdom to ensure uniformity in the genetic composition of the plants, which are then processed into a liquid solution of CBD. 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 that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.

Nine states and the District of Columbia have legalized marijuana for recreational use.

Medical marijuana is legal in 29 states, Guam and Puerto Rico. This status has stifled rigorous research, because the federal government will not pay for it. Accordingly, before Epidiolex is ready for use amongst patients, it needs to be appropriately reclassified - something GW Pharmaceuticals expects to see happen within the next three months. Previous year a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health. It's in phase 3 testing for a potential approval in the U.S. The company is also working on cannabinoid programs against glioblastoma, schizophrenia and more.

The European Medicines Agency is expected to rule on the therapy in early 2019.

Related Articles

  • US approves Epidiolex, first marijuana-derived drug

    US approves Epidiolex, first marijuana-derived drug

    Prior to the FDA decision, a press officer for the DEA confirmed to Leafly that the FDA decision will prompt action from the DEA. The family moved to Colorado in 2014 to take advantage of that state's more advanced medicinal marijuana program.
    No unrest in Argentina camp! - Sampaoli

    No unrest in Argentina camp! - Sampaoli

    At that point, goal differential would decide who advances into the last 16, with Denmark starting play at +1 and Australia kicking off at -1.
    Donald Trump attacks Harley-Davidson for moving production away from the US

    Donald Trump attacks Harley-Davidson for moving production away from the US

    Correction: Harley-Davidson said it will be moving production to its worldwide factories , not necessarily to factories in Europe. Harley-Davidson claimed Monday that the EU's action increased the tariffs on its motorcycles "from six percent to 31 percent".
  • Brand

    Brand "Messi" unblemished by poor World Cup

    Chelsea midfielder Cesc Fabregas has come out in defence of his friend Lionel Messi and downplayed Cristiano Ronaldo's start to the World Cup in Russian Federation .

    'Never called this human in my life': Fallon responds to Trump's tweet

    I agreed to do his show, and because I guess I was running at the time, he got tremendous ratings on that show. The Tonight Show Starring Jimmy Fallon airs weeknights at 11:35 on NBC .
    Prince William Just Recreated a Photo of 4-Year-Old Kate Middleton

    Prince William Just Recreated a Photo of 4-Year-Old Kate Middleton

    He is also due to meet the Palestinian Authority president, Mahmoud Abbas , in Ramallah in the West Bank. Official visits by British royals are organised at the request of the United Kingdom government.
  • Amandla Stenberg Rocks Rainbow Hair to BET Awards

    Amandla Stenberg Rocks Rainbow Hair to BET Awards

    Drake is also a double nominee for video of the year with "God's Plan" and "Walk It Talk It" with Migos. Miguel, in a white suit, was smooth as he sang the songs "Come Through and Chill" and "Sky Walker".
    United States  will crack down on all countries trying to steal its technology

    United States will crack down on all countries trying to steal its technology

    The Dow Jones Industrial Average lost almost 500 points before reversing course to close down 328 points, or 1.3percent. Meanwhile, later this week, the Treasury Department is due to unveil a proposal on investment and export restrictions.
    Hierro admits Spain lucky to top World Cup group

    Hierro admits Spain lucky to top World Cup group

    The midfielders combined all over the pitch and Isco was particularly threatening down the wing as Spain pushed forward. De Gea was criticized after his blunder gave Ronaldo one of his three goals in in Spain's draw with Portugal.
  • France look to continue winning run against Denmark

    France look to continue winning run against Denmark

    Four years ago, France were 2-0 winners at the Estadio Nacional Mane Garrincha in Brasilia, kicking the Eagles out of Brazil 2014. The 2018 World Cup went a record 27 matches without a goalless draw last week following Eden Hazard's penalty against Tunisia.
    Wozniacki calls for Serena seeding at Wimbledon

    Wozniacki calls for Serena seeding at Wimbledon

    But when McEnroe was asked about the downsides of "de-seeding" the player in 32nd place on the pecking order, he shook his head. She withdrew from the tournament before a fourth-round match with Maria Sharapova , citing a chest-muscle injury.
    Irish scientists claim to be able to slow Alzheimer's disease

    Irish scientists claim to be able to slow Alzheimer's disease

    This new study , he explained showed -V6 and HHV-7 viral genes within the brains of persons with Alzheimer's after they had died. Despite decades of research, scientists have made little progress in halting Alzheimer's disease, a form of dementia.