Medical

FDA approves first ever drug derived from marijuana

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.

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.

Research has shown that CBD has the potential to treat seizure conditions, like Dravet syndrome.

The drug is derived from the cannabidiol of cannabis, and, as the plant is yet to be decriminalized by federal regulators, its approval gives GW Pharma a lead among cannabis-exposed companies in the USA financial markets. The move could open the doors to other marijuana-derived medications as well as ease heavy restrictions on marijuana-related research. Until now, the Drug Enforcement Administration has classified CBD as a Schedule 1 substance.

FDA officials noted the significance, signaling a new approach to looking at a plant still defined in federal law as having "no now accepted medical use".

In Ohio, a bill in the Senate would remove drug schedules from state law and instead have the state pharmacy board schedule substances in rules and regulations.

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. The companies behind those products say the CBD is extracted from hemp, which contains little THC, and is allowed under the federal farm bill.




The DEA did not immediately respond to Ars' request for comment. The company expects this to happen in the next 90 days.

Today's approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies. The drug reduced seizures by half in 40 percent of Dravet patients participating in the trials.

Many parents already are giving children unregulated CBD formulations that are available in medical marijuana dispensaries in the many states where such operations are legal. But CBD products available in retail stores can have unreliable concentrations or poor quality controls. "We want the whole-plant extracts that our kids are using and that have worked for them for years".

"This is clearly a breakthrough drug for an very bad disease", John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug.

One recent study into CBD found that a significant number of products didn't contain the amount of CBD that they claimed to on the label.

"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.

"This is an important medical advance", FDA Commissioner Dr. Scott Gottlieb said in a statement Monday.


  • Cavaliers select Alabama's Sexton with No. 8 pick

    Cavaliers select Alabama's Sexton with No. 8 pick

    If there's no good landing spot or flawless landing spot for him then Cleveland maybe turns out by default to be the best place. According to ESPN's Brian Windhorst, no one in the current roster is guaranteed their spot if the four-time MVP leaves.
    U.S. okays marijuana-based drug for seizures

    U.S. okays marijuana-based drug for seizures

    Prior to the FDA decision, a press officer for the DEA confirmed to Leafly that the FDA decision will prompt action from the DEA. It's not clear how quickly the drug will be available for prescription.
    Ariana Grande, Pete Davidson move into luxury apartment in NY

    Ariana Grande, Pete Davidson move into luxury apartment in NY

    He appeared on The Tonight Show With Jimmy Fallon , where he said, " It's lit ". "I feel like I won a contest", he added. She was also seen wearing it during a trip to Disneyland California with Davidson last Monday.
  • The attractive  meaning behind the NZ Prime Minister's new baby name

    The attractive meaning behind the NZ Prime Minister's new baby name

    Prime Minister Ardern is the second world leader to give birth in office, and the first elected leader to take maternity leave. He plans to become the primary caregiver for the child when Ardern returns to work following a leave of six weeks.

    Jimmy Fallon to Donald Trump: Why Are You Tweeting at Me?

    Add Donald Trump as an interest to stay up to date on the latest Donald Trump news, video, and analysis from ABC News. Trump also kept alive his weekend attack on Jimmy Fallon and opened up a new front: a war with Stephen Colbert .
    Roger Federer to face Borna Coric in Gerry Weber Open final

    Roger Federer to face Borna Coric in Gerry Weber Open final

    The Aussie double-faulted to hand over four set points but one was enough as Federer hit a backhand service return victor . Federer, who won the opening set with back-to-back aces, fell 4-0 down in the second set as Paire rallied.
  • Messi fan goes missing after Argentina loses World Cup

    Messi fan goes missing after Argentina loses World Cup

    Suspecting suicide, the fire and rescue team launched a search in the waters but the operation was halted due to incessant rains. A native of Arumanoor village near Kottayam , Dinu was last seen by his parents watching late night football match at his home.
    Hernandez hits half-century as Mexico lay one foot in knockouts

    Hernandez hits half-century as Mexico lay one foot in knockouts

    Javier Hernandez has played for some big clubs in world football, and his ability has never been in doubt. The victory against Germany has even reinforced the mindset we've had for a long time now.
    USA  to set no timeline in North Korea's denuclearization: Pompeo

    USA to set no timeline in North Korea's denuclearization: Pompeo

    In 2002, North Korea admitted that it kidnapped 13 Japanese in the 1970s and 1980s, and five returned home. North Korea's state media were filled with reports, photos, and video of the June 12 meeting between Mr.
  • Apple iOS 12 public beta: How to install, top features, and more

    Apple iOS 12 public beta: How to install, top features, and more

    Apple's new set of Animojis are also available along with " Memoji " which lets users create an animated version of them. The new iOS has a lot of performance improvements, according to Apple, so it might make your old phone run faster.
    Prince William Pays Tribute to Kate Middleton

    Prince William Pays Tribute to Kate Middleton

    Princess Alice hid three members of the Cohen family in her palace in Athens during the Nazi occupation of Greece in World War II. The Palestinians claim east Jerusalem as their future capital.
    Argentina take player power to new level ahead of Nigeria clash

    Argentina take player power to new level ahead of Nigeria clash

    Shortly after the thrilling shambles of a match that was Croatia versus Argentina , Pablo Zabaleta made an interesting point. If Iceland wins, then Sampaoli's side can still qualify if it beats Nigeria by two more goals than Iceland wins its game.