• News
  • Health Care

FDA Approves First Marijuana Based Drug

FDA Approves First Marijuana Based Drug

GW Pharmaceuticals Plc's epilepsy treatment on Monday secured an approval from the U.S. Food and Drug Administration, becoming the first cannabis-based drug to be approved in the country.

The active ingredient in Epidiolex, an epilepsy medication, is cannabidiol (CBD), one of the two main chemical compounds found in marijuana. But it's not quite medical marijuana. But some parents worry it could hurt Colorado's cannabidiol (CBD) industry already helping children who are suffering from seizures. 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.

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

Not long after the NEJM report, GW Pharmaceuticals, which operates in the U.S.as Greenwich Biosciences, applied for FDA approval of Epidiolex. "In the artisanal products there's often a huge variation in doses from bottle to bottle depending on where you get it".

CBD has medicinal effects, but it does not cause the mind-altering high that comes from THC, the primary psychoactive component of marijuana. Heather Jackson of Colorado Springs gave it to her son. Her 13-year-old daughter, Molly, has suffered from severe seizures since she was 4 months old. Those taking 20 mg of Epidiolex a day had 42 percent fewer seizures, on average, compared with 37 percent fewer seizures in the group taking 10 mg of the drug, and a 17 percent reduction in the placebo group. As well, CBD remains in a legal grey area, making it hard for patients outside of legal states to acquire. The drug is derived from the cannabis plant and not synthetic in nature like prescription THC drugs (Marinol and Syndros) available as an appetite enhancer for people with HIV/AIDS.

Now with the approval of Epidiolex, a drug that will not produce an euphoric "high" feeling in the user - Devinsky said he expected CBD would be moved down to a schedule 4 or 5 drug, which is one that poses a low potential for abuse and dependence. The FDA has previously sent warning letters to companies that hyped their products as cancer or Alzheimer's fighters.

But Heather Jackson of Realm of Caring, a charity affiliated with the CBD company CW Hemp, tells the outlet, "I don't know a mom or dad in their right mind who is going to change what's already working". Shinnar said he will welcome approval of a medicine that had undergone stringent FDA review for safety and effectiveness.

Several researchers are studying the potential of CBD to treat psychiatric conditions.

GW Pharmaceuticals said it expected to make the product available by the fall, pending expected action by the Drug Enforcement Administration to reclassify the drug. GW Pharmaceuticals grows the plants in the United Kingdom. GW Pharmaceuticals has monitored Epidiolex' effects on over 500 children and adults who are afflicted with seizure conditions that are hard to treat using traditional medications for epilepsy.

But doctors will have the option to prescribe it for other uses.

Nine states and the District of Columbia have legalized marijuana for recreational use. "We want the whole-plant extracts that our kids are using and that have worked for them for years".

As a result, Epidiolex's launch remains at the discretion of the DEA, which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, so as to allow GW to begin selling it.

Federal agencies have 90 days to determine the scheduling of Epidiolex. And the company plans to continue importing the medicine, bypassing onerous USA regulations on manufacturing restricted substances.

The Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education.

Leave Your Comment

Leave Your Comment


Latest News

  • Harley, stung by tariffs, shifts some production overseas

    Harley, stung by tariffs, shifts some production overseas

    However, Harley said it was only moving production out of the US that is to be sold in Europe. The action comes in response to tariffs the European Union imposed on USA -made motorcycles.
    Colombia captain wants World Cup team to use past resolve

    Colombia captain wants World Cup team to use past resolve

    Thus far, the World Cup has been hard to predict, with some of the best teams falling to underdogs and confounding the experts. Coming in the third minute, it was the second fastest red card in World Cup history and the first of this year's tournament.
    Pogba: I had minor issues with Mourinho

    Pogba: I had minor issues with Mourinho

    Pogba and France are back in action against Denmark on Tuesday to decide which team will top Group C, and theoretically, avoid Croatia.
  • Girl In Sex Video Receives Threats After Junior Guzman-Feliz's Murder

    Girl In Sex Video Receives Threats After Junior Guzman-Feliz's Murder

    An additional person was picked up in the Dominican Republic and is now cooperating with the investigation, with no charges filed. Mayor Bill De Blasio on Monday said he wants to find a way to honor the teen in a lasting way. "I know it doesn't mean a lot".
    Cardi B and Offset Secretly Married

    Cardi B and Offset Secretly Married

    UPDATE 4:01 PM: Cardi B has confirmed the report with a statement posted on her Twitter account. She's also at No. 5 on the chart as a featured artist on the Maroon 5 song "Girls Like You".
    Meghan Markle Just Made History With Award Nod

    Meghan Markle Just Made History With Award Nod

    But their relationship is now very fractured, and it is impossible to know how it will end ." . He still hasn't met Harry, and is desperate for it to happen", the insider noted.
  • WSU quarterback Tyler Hilinski had brain disease CTE, family says

    WSU quarterback Tyler Hilinski had brain disease CTE, family says

    We may never know the reason why Ty did what he did but we know how we can continue to make him happy even when he's not here. Following Hilinski's death, the Mayo Clinic asked the family if it could conduct an autopsy of Tyler's brain.

    Argentina's Last Gasp Win Told Through The Medium Of Diego Maradona

    Here are five things we learned as Group C concluded this afternoon. First though, they have to escape the group stage.
    Prince William begins first royal visit to Israel

    Prince William begins first royal visit to Israel

    Netanyahu on Monday issued a statement ahead of Prince William's visit, welcoming him on behalf of the citizens of Israel. A Middleton family photo shows Kate in Jerash with her father and younger sister Pippa.
  • FIFA 2018 | France vs Denmark: A mutually beneficial stalemate

    There have already been 20 penalties given at this World Cup , a tournament record before the group stage has even concluded. Yussuf Poulsen was suspended against France after picking up his second yellow card of the tournament against Australia.
    Socceroos eliminated, Peru leave Russia on high note

    Socceroos eliminated, Peru leave Russia on high note

    But if Australia's finish to the first half gave fans confidence, an almighty sucker-punch was just around the corner. Winger Mathew Leckie was then denied in the goalmouth by a scrambling defence in the 36th minute.
    The Public Beta for iOS 12 is Here

    The Public Beta for iOS 12 is Here

    Apple has run a Switch to iPhone campaign for years and offers a Move to iOS app for Android switches in the Google Play Store. This means those in the public Apple Beta Software Program can now install this test software on their devices.
  • Meghan Markle wears Prada while hosting awards ceremony alongside the Queen

    Meghan Markle wears Prada while hosting awards ceremony alongside the Queen

    Meghan , Harry and The Queen all looked prim and proper at the Queen's Young Leaders Reception on June 26. Thomas says he has most beef with Her Majesty the Queen .
    Ronaldo quiets Iran fans down from hotel room before Portugal match

    Ronaldo quiets Iran fans down from hotel room before Portugal match

    As per the rules, both games will be played concurrently at 6: 00 PM GMT and we will give you updates on both games. Portugal need at least a point from their final match against Iran to guarantee a place in the knockout round.
    Spain held by Morocco but Iago Aspas goal ensures they face Russian Federation

    Spain held by Morocco but Iago Aspas goal ensures they face Russian Federation

    The midfielders combined all over the pitch and Isco was particularly threatening down the wing as Spain pushed forward. You can stream all World Cup matches with fuboTV (Try for free).
  • Iceland v Croatia 26 June 2018

    Croatia had its first clear chance when Milan Badelj's missile crashed onto the bar six minutes into the second half. They have as many clean sheets from this World Cup as they do from all of their other appearances combined.
    Fallen Kingdom explodes to $150 million opening weekend

    Fallen Kingdom explodes to $150 million opening weekend

    The first Jurassic World came out in 2015 and made no mention of then-President Barack Obama. Ads for the movie have appeared on all sorts of products such as Doritos, Dr.
    James Harden wins his first NBA Most Valuable Player award

    James Harden wins his first NBA Most Valuable Player award

    Although the season has come to a close , the National Basketball Association still has plenty of loose ends to tie up. The guard became the first player to average at least 20 points for the first time in his 13th season or later.

Breaking News



Recommended

Why the Survivors of 'Avengers: Infinity War' Are Important to 'Avengers 4'

What are we looking at? It's the kind of profound send-off that could make you cry if you weren't already crying over Spider-Man's last lines.

New Honda-Red Bull F1 partnership offers…

Just normal, gentle discussions". "Past year after the Suzuka Grand Prix, I invited Dr. I'm pretty sure we will discuss that [with Red Bull] in the next few weeks.

French Grand Prix qualifying: Hamilton takes POLE on Mercedes front row

Bottas suffered a puncture and had to limp back to the pits for new tyres, eventually finishing in seventh. Luckily, both drivers didn't lose much ground as they pitted for repairs under the Safety Car.

US Open Tennis to alter seeding following Serena's return

She added that seedings for the tournament would be revised "if pregnancy is a factor in the current rankings of a player". Will Williams be seeded for Wimbledon? "Forget the fact that she has won 23 majors and what she brings to the table".

Harley-Davidson to Outsource More US Manufacturing Jobs, Trump Calls Move 'Excuse'

The company operates manufacturing facilities in Brazil, India and Australia, and is beginning production in Thailand this year. The firm's stock fell nearly 6% to $41.57 in a turbulent day for U.S. stocks amid concerns of a trade war.

China, EU to form group to modernise global trade rules

Treasury Secretary Mnuchin has been reluctant to back steep tariffs on Chinese goods, fearing the impact on global supply chains. Amazon shares fell more than 3.5%, while shares of Google and Facebook fell 3.67% and 3.77%, respectively.

‘#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. However, with free agency nearing, it appears as though some of James' best options are falling away.

Is Messi about to play his final match for Argentina?

Croatia will play Iceland on Tuesday at the Rostov Arena, while Nigeria and Argentina will lock horns in Saint Petersburg . The draw against Argentina was an upset, but Iceland then dropped the next game 2-0 to Nigeria .

McIlroy and Spieth bounce back from US Open

Justin Thomas, front, couldn't get started in the first round of the Travelers Championship Thursday in Hartford. McIlroy bogeyed the last hole to put himself one stroke behind the leader heading into Friday.

Ariana Grande’s fiancé Pete Davidson CONFIRMS engagement

Sweetener is Grande's fourth studio album and her first since a terrorist attacked one of her concerts in Manchester in May 2017. Pete appeared to help her get out of the vehicle and down the step exiting with those huge heels she had on.