USA approves first marijuana plant-derived drug for epilepsy

Marissa Parsons who has Lennox Gastaut syndrome visits the Grand Canyon with her family in 2016

Experts are hopeful that the approval will unleash a wave of new interest in the potential medical applications of CBD and other marijuana compounds. 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.

The FDA previously cleared medications containing synthetic versions of THC for nausea for patients getting chemotherapy and for other uses, but it had not approved any drug derived from the plant itself.

Treatments available for both disorders are far from ideal and some patients resort to buying "self-prescribed" CBD online or from unregulated vendor sites, Dr. Pavel Klein, founder of the Mid-Atlantic Epilepsy and Sleep Center, said.

The FDA notes that it will still "take action" against illegal CBD products making "serious, unproven medical claims".

"I'm really happy we have a product that will be much cleaner and one that I know what it is", said Dr. Ellaine Wirrell, director of the Mayo Clinic's program for childhood epilepsy. But then Hendershot learned about a trial of Epidiolex at New York University.

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

Epidiolex won't require a special certification to prescribe, Patel said, and it's likely physicians will prescribe it for off-label uses. The move could open the doors to other marijuana-derived medications as well as ease heavy restrictions on marijuana-related research.

"I don't know a mom or dad in their right mind who is going to change what's already working", said Heather Jackson, CEO of Realm of Caring, a charitable group affiliated with Colorado-based CW Hemp, one of nation's largest CBD companies.

Patel helped run trials here testing Epidiolex to treat Dravet syndrome and Lennox-Gastaut syndrome, two rare, often drug-resistant forms of epilepsy that start in childhood.

For a maligned substance like cannabis, I think the vindication tour will ultimately be years long.

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

Epidiolex, manufactured by GW Pharmaceuticals in the United Kingdom, is made from cannabidiol, the non-psychoactive part of the cannabis plant.

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.

Called Epidiolex, the drug is created to treat two rare forms of childhood epilepsy using a cannabis compound called cannabidiol (or CBD).

In some cases, patients have moved to states that have legalized medical marijuana in order to have access to the drug. But Garris highlighted that numerous side effects occur when it is taken with other medications, which she said is a concern because most patients are on other medications.

The European Medical Society is also considering approval of Epidiolex and is expected to announce a decision in the first quarter of next year, according to Gover.

Related News:

  • Fallen Kingdom' Tops Box Office & Exceeds Expectations!

    Fallen Kingdom' Tops Box Office & Exceeds Expectations!

    Openings in Brazil, Central America, Argentina, Colombia and Chile were among those that topped the previous film this weekend. The big weekend adds to the film's worldwide haul of $711.5 million since opening overseas earlier this month.
    ‘He should have walked!’ Fury at Ronaldo red card let-off

    ‘He should have walked!’ Fury at Ronaldo red card let-off

    VAR has been called upon in half of the 20 penalty decisions, whether to change the referee's original call or to confirm it. But the Portugal captain was denied by Beiranvand who dived to his left to smother Ronaldo's attempt.
    White Woman Calls Police On 8-Year-Old Girl Selling Water

    White Woman Calls Police On 8-Year-Old Girl Selling Water

    The incident has even caught the attention of celebrities including actress Gabrielle Union. "She permanently wears folks OUT". Alison Ettel told the San Francisco Chronicle that the girl and her mother had been making noise for several hours.
  • California wildfire forces families from homes

    California wildfire forces families from homes

    A scanner report indicated at least one structure had become involved and the fire had jumped Baker Road at Walnut Street. As of Sunday, there was no containment and it burned across about 12 square miles, or about 7,700 acres.
    Mo Salah Reportedly Contemplating Leaving International Football

    Mo Salah Reportedly Contemplating Leaving International Football

    This is the second time Salah has had a disagreement with the Egyptian Federation over the unauthorized use of his image . Egyptian football officials responded to the criticism by saying that Grozny was on FIFA's list of approved cities.
    Harley-Davidson Announces Overseas Move, Cites Tariffs

    Harley-Davidson Announces Overseas Move, Cites Tariffs

    The EU levied the tariffs, which became effective on Friday, in response to increased USA tariffs on European steel and aluminum. What is Harley-Davidson doing? The company said it will raise investment in its global plants, but did not say which ones.
  • Apple is developing high-end AirPods, two other enhanced audio accessories

    Apple is developing high-end AirPods, two other enhanced audio accessories

    The new AirPods will also have increased Bluetooth range and could come with a heart-rate monitor like the Apple Watch . It was previously reported that Apple was working on a new pair of AirPods with improved sound and build quality.
    Costa Rica disappointed after Brazil defeat

    Costa Rica disappointed after Brazil defeat

    Many thought they would steamroll Switzerland in their Group E opener, but the European side held out for a 1-1 draw . The PSG star collapsed to the ground and burst into tears while the rest of his team-mates celebrated.
    Who needs what to qualify in the final round of group games?

    Who needs what to qualify in the final round of group games?

    Now if that doesn't assure you of the quality of football that is on display in Russian Federation , we don't know what will. A win for La Roja could see them finish top of the group and a draw will be good enough to see them advance to the last 16.
  • Cardi B confirms she married Offset past year

    Cardi B confirms she married Offset past year

    She's also at No. 5 on the chart as a featured artist on the Maroon 5 song "Girls Like You". She said the two just "woke up and chose to get married" one day past year .
    Supreme Court won’t hear case of anti-gay marriage florist

    Supreme Court won’t hear case of anti-gay marriage florist

    Her home , business, savings and personal assets are all at risk in the case . "It's up to the courts to put an end to this". ADF, which represents Stutzman, expects the Washington Supreme Court "to follow the law", Waggoner said . - The U.S.
    Mascherano denies rift between players and coach Sampaoli

    Mascherano denies rift between players and coach Sampaoli

    In two World Cup games, the only constant has been the fact that Argentina can not get out of its own way. On Thursday they staged an epic second half collapse on their way to losing 3-0 to Croatia.


Most liked

Spieth rebounds, shares Travelers first-round lead
The three-time major champion said he went out to the practice range after his round Thursday to make some corrections. I've just got to go out there and just keep the blinders on and focus on the holes and the shot at hand.

Argentina's Javier Mascherano denies rift between players and coach Jorge Sampaoli
Former Barca midfielder Emmanuel Petit, who won the World Cup with France, wants to see a better mentality from Messi. Nigeria have three points from two, Iceland have one from two and Argentina have one from two.

Meek Mills debuts powerful new song about police violence
So it's no surprise that Jamie Foxx , host of Sunday night's BET Awards , is just as obsessed with the song as the rest of us. Taking a break from his advocacy work, he took to the stage for a powerful performance at the BET Awards .

NYPD Explorer Murdered By Street Gang
He was walked out of the 48th Precinct overnight, and is being charged with murder, manslaughter, gang assault and felony assault. Guzman-Feliz's grieving family received the white-glove treatment as cops ushered them to the funeral parlor in NYPD vans.

Meghan Markle Taking Over One of The Queen's Tasks
The royal family will gather at The Chapel Royal next month to celebrate the christening of their newest family member. But it will only be when she settles into her royal role that she'll receive the "Mama" green light.

Trump meets with families of loved ones killed by immigrants
James Lankford says the White House needs to do a better job explaining why families were being separated at the southern border. Trump once again railed against USA immigration laws, calling them a "mockery" to law and order in his tweetstorm.

Switzerland hero Xherdan Shaqiri coy on politically-charged celebration
However as we all know now, that wasn't the case as Brazil have made it look like this is much harder for themselves than it should probably be.

Erdogan leads early count in pivotal Turkey poll
Supporters of Turkish President Tayyip Erdogan cheer in front of AKP headquarters in Istanbul , Turkey, on June 24. Late Sunday , supporters chanted slogans and light torches outside his palace in Instanbul.

Mysterious lump moving around woman's face was actually a parasitic worm
A short trip to the doctor made her realize that the thing was actually a parasite moving back and forth under her skin. Other than Europe, this parasite is also found in the Mediterranean region and sub-Saharan Africa.

House rejects conservative immigration bill, delays vote on second measure
It came a day after Trump - in a stunning about-face - moved to end the practice of splitting migrant families after they cross into the United States from Mexico.

Analysts Expect Harley-Davidson (HOG) Will Announce Earnings of $1.36 Per Share
Ballew Advisors Inc bought a new position in Harley-Davidson in the first quarter worth approximately $134,000. The company had revenue of $1.54 billion for the quarter, compared to the consensus estimate of $1.24 billion.

Heather Locklear Arrested for Battery on a Police Officer and Emergency Personnel
Locklear checked into a rehabilitation facility in the wake of that arrest, during which she was allegedly intoxicated. Locklear pleaded not guilty to the charges in April but she was barred from owning or possessing a firearm.

Pompeo says won't put timeline on North Korea denuclearization steps
Pompeo has said in the past that he wanted to see full North Korean denuclearization before the end of Trump's first term in 2020. North Korea propaganda outlet Uriminzokkiri focused on the returns of US remains, and described the policy as a step forward.

USA 'will not help' Syrian rebels repel Assad forces
If the Syrian Army retakes this town, it will cut off the rebel forces in al-Lajat plateau from the larger rebel Daraa pocket. Many have sought refuge in poorly-resourced displacement camps further west, with little access to food or water.

Trump order sows confusion on the border — WHAT'S HAPPENING
Beata Mariana de Jesus Mejia-Mejia sued the administration in federal court, forcing the Justice Department to release the child. Six of the children were separated from their families upon reaching the border, while the rest arrived unaccompanied.