Cannabis Medicine To Treat Epilepsy Officially Approved By FDA

Cannabis Medicine To Treat Epilepsy Officially Approved By FDA

The U.S. Food and Drug Administration has approved a marijuana-deriveddrug for the treatment of two rare and serious forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, that begin in childhood but can persist in adulthood.

The drug contains cannabidiol, or CBD, a substance derived from marijuana, but causes no intoxication, euphoria or "high", the FDA said. The drug, called Epidiolex, is an oral solution containing highly purified cannabidiol (CBD), which is one of scores of chemicals in the cannabis sativa plant, commonly known as marijuana.

Before GW can market Epidiolex, though, the Drug Enforcement Administration will have to reclassify CBD, which in this case, because it comes from marijuana, is considered a Schedule I drug, meaning it has no medical value and a high risk of abuse. Almost all patients with these conditions continue to have daily seizures-some having multiple per day-despite the use of legally available drugs.

"Compared to other drugs used to treat epilepsy, I think Epidiolex, which is 99-percent pure cannabidiol, has a better side-effect profile than numerous available drugs", Devinsky said. 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.

A government-regulated version of the oil will ease some doubts about the amount of CBD in the product, which can vary based on its origin, said Dr. Elaine Wirrell, director of the Mayo Clinic's child epilepsy program. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician's care.

Carson says he will likely prescribe Epidiolex going forward.

Pharmacist denies woman miscarriage drug on moral grounds
The day before, she learned her pregnancy would end in a miscarriage. "I didn't want to need those pills", Arteaga said. But what he failed to understand is, this isn't the situation I had hoped for - this isn't something I wanted.

And Epidiolex's approval doesn't mean other CBD substances are OK to sell, Gottlieb said. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions.

For their part, GW Pharmaceuticals executives say they are not trying to disrupt products already on the market.

The FDA's decision was not unexpected, as the proprietary extract formulation - developed by the British biotechnology firm GW Pharmaceuticals - had previously demonstrated safety and clinical efficacy at reducing seizure frequency in several placebo-controlled trials.

A total of 30 US states, the District of Columbia, Guam and Puerto Rico allow the use of medical marijuana in some form, according to the US National Conference of State Legislatures.

Despite increasing acceptance, there is little rigorous research on the benefits and harms of marijuana. That decision is expected within 90 days. One in five patients is estimated to die before they are 20 years old. And the company plans to continue importing the medicine, bypassing onerous US regulations on manufacturing restricted substances.

The FDA's first approval of a cannabis-derived compound happened thanks to sound science, and it must proceed that way. The AP is exclusively responsible for all content.

Related News:

  • Messi is frustrated and hungry - Mascherano

    Messi is frustrated and hungry - Mascherano

    The forward scored two goals against Iceland in their second game as the three times African champions won 2-0. A Nigeria win would send the Icelanders and Argentinians both home.

    FDA Approves Marketing Of Plant-Derived Marijuana Medicine

    A new drug derived from marijuana just became the first of its kind to get the green light from the USA government. Marissa Parsons, who has Lennox-Gastaut syndrome, visits the Grand Canyon with her family in 2016.
    Apple plans new, improved AirPods, HomePod and over-ear headphones

    Apple plans new, improved AirPods, HomePod and over-ear headphones

    These were supposed to come out later this year, but they ran into issues and the release was pushed back to early next year. However, production hasn't started, and design and technology partnerships for the product haven't been finalized.
  • Maradona calls for meeting with Argentina players

    Argentina face Nigeria but a win wont guarantee them passage to the next round, and will reliant on the result of Croatia and Iceland .
    Ricardo Quaresma Scores Physics-Defying Goal For Portugal Vs. Iran

    Ricardo Quaresma Scores Physics-Defying Goal For Portugal Vs. Iran

    Portugal have made three changes for this one. 20' Portugal avoid the danger after long pass from Iran player lands in the box. Notably, the only way Iran can qualify for the round of 16, is if they beat the European champions tonight.
    Trump warns Maxine Waters: 'Be careful what you wish for'

    Trump warns Maxine Waters: 'Be careful what you wish for'

    The owner of the Red Hen , Stephanie Wilkinson, said she told Sanders to leave the restaurant after consulting with her staff. Maxine Waters (D-Calif.) told her supporters to harass members of the Trump administration.
  • United States  says still working to reunite 2 053 children with families

    United States says still working to reunite 2 053 children with families

    Kilmer said he had official tours set up at both facilities but that it was canceled due to protest-related safety concerns. But they said the experience has already left lasting emotional and psychological scars on them and their children.
    ‘Making A Murderer’ Subject Denied U.S. Supreme Court Appeal

    ‘Making A Murderer’ Subject Denied U.S. Supreme Court Appeal

    The attorney representing an inmate featured in the " Making a Murderer " series is vowing to keep fighting for him after the U.S. Stutzman appealed, saying she had a right to refuse the couple based on her opposition to same-sex marriage.
    Spieth may add event to schedule ahead of Open defense

    Spieth may add event to schedule ahead of Open defense

    He started like a train, rattling in birdies at four of his first six holes before knocking in three more in a row from the 13th. This year's field at the tournament includes five of the top 10 golfers in the world, as rated by the World Golf Rankings.
  • Prince William arrives in Israel for talks with Netanyahu

    Prince William arrives in Israel for talks with Netanyahu

    On his first day in Jordan, William and the Crown Prince watched England's world cup match versus Panama, which England won. Prince William is now on a royal tour of the Middle East without his wife Kate Middleton , who's on maternity leave.
    Belgium reaches World Cup knockout stage with 5-2 win over Tunisia

    Belgium reaches World Cup knockout stage with 5-2 win over Tunisia

    Belgium , with a win over Panama in its opening match, were eager to get another victory so as to advance to the knockout stage. Romelu Lukaku , who scored two against Panama, spearheads the Belgian attack, supported by Eden Hazard and Dries Mertens.
    We have weapons to beat Uruguay-Portugal coach Santos

    We have weapons to beat Uruguay-Portugal coach Santos

    Messi's men have to beat the Super Eagles to move onto four points, giving themselves a chance of progressing. Spain are nearly certain to progress unless Iran beat Portugal and Spain lose to Morocco by a wider margin.


Most liked

WSU quarterback Tyler Hilinski had brain disease CTE, family says
Was that the only thing that contributed to his death? "I don't know", Kym said in a Sports Illustrated documentary . The family told SI's Greg Bishop that they noticed a change in Tyler after the Arizona game.

‘#KingsJames’: Billboard Floats Idea of LeBron James Playing for Sacramento
The inclusion of the Wizards is just as puzzling as there hasn't been any talk of them being in the picture as a landing spot. James could re-sign with the Cavaliers on a short-term deal that allows him to weigh his future again in a year or two.

China defends its U.S. investment record
Trump threatened to hit another $200-billion of Chinese goods with an extra 10 percent tariff after Beijing retaliated. Alphabet, the parent of Google , fell 2.6 percent, Apple lost 2.75 percent, and Amazon dropped 3.0 percent.

Ariana Grande, Pete Davidson are engaged
Sweetener is Grande's fourth studio album and her first since a terrorist attacked one of her concerts in Manchester in May 2017. The talks were not without basis as both Ariana and Pete have been made their relationship very public.

Paul Pogba Makes Shock FIFA World Cup Claim
Subscribe to our SMS sports service by texting "SPORTS" to 22840. "These things make you grow also", he stated. He said: "It was a better season that the previous one". "It was an experience".

Spain top group after thrilling finale
The result means Spain will now face host Russian Federation in the round of 16 on Sunday. Morocco played with heart and were brilliant on counters as well as resolute on the back.

Jersey Shore's Ronnie Ortiz-Magro's ex-girlfriend arrested for domestic battery
Jen lunged, spit and shoved Ronnie. "Ronnie and Jen have been fighting over their daughter", a source told Us at the time. The 32-year-old reality star is now shooting season two of Jersey Shore: Family Vacation in Las Vegas.

Jurassic World sequel crosses $700 million at global box office
That's a beyond incredible opening weekend for most animated films and made for a massive weekend for Hollywood. The big weekend adds to the film's worldwide haul of $711.5 million since opening overseas earlier this month.

Kane's fluky hat trick powers England
England were 5-0 in front at halftime as they roasted their opponents, who are ranked 55th in the world. And after England's biggest ever tournament win, Kane insists the Three Lions can win the World Cup.

Why Meghan wears shoes that are too big for her
The insider added Meghan's father is anxious the interview may have changed things. The father-of-three wished he'd been well enough to perform the duty himself.

Trump says people from Mexico 'invade' US
In recent days, the focus has shifted to the Trump administration's wrenching of migrant children from their parents. Now, much of the battle on Capitol Hill centers on the treatment of the newer influx of migrants.

Turkey's Erdogan faces resurgent opposition in twin election test
The victor will get new sweeping powers under a constitutional shake-up approved in a referendum previous year . The vote has also ushered in an executive presidency system giving Mr Erdogan sweeping new powers.

Tite takes a tumble celebrating Brazil goal at World Cup
I gave the ball back because it wasn't going to be that ball that would make us win. Congratulations for the performance, guys", he added.

FIFA investigates Shaqiri and Xhaka celebrations
The player said in a post-match interview his celebration was "just emotion" but added he was not allowed to talk about politics. Shaqiri had hit the crossbar in the first half before substitute Mario Gavranovic played him in to grab the dramatic victor .

NYPD IDs 1 of 5 suspects in mistaken-identity machete killing
Another service is being held Tuesday from 3 to 9 p.m., and Guzman-Feliz will be laid to rest Wednesday at St. Former Knick Carmelo Anthony and TV personality La La Anthony visited Guzman-Feliz's family Monday.