First Cannabis-Based Drug For Childhood Epilepsy Approved in USA
Jun 28, 2018, 00:49
Here's how FDA Commissioner Scott Gottliebput it: "It's also important to note that this is not an approval of marijuana or all of its components".
"And, the FDA is committed to this kind of careful scientific research and drug development". When taken with other medications, Epidiolex was shown to be effective in reducing the frequency of seizures in patients compared to those who took a placebo.
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...
This one landmark approval could have another one following it soon: the reclassification of CBD by the United States Drug Enforcement Administration. Catherine is part of the drug company's clinical trial.
Because CBD is still a Schedule 1 drug - those with a high potential for abuse and no medical value - GW can not market Epidiolex until the U.S. Drug Enforcement Administration reclassifies it, which is anticipated to occur within 90 days. "This should allow patients to have access to consistent cannabidiol doses made to the highest quality standards". The decision caps decades of work by the company to gain approval in the US for a medicine derived from the cannabis plant. The first is Dravet syndrome, which is a rare genetic dysfunction that starts within a child's first year, and the second is Lennox-Gastaut syndrome, which is a form of epilepsy that causes multiple types of seizures usually starting from 3 to 5 years old.
He said there are thousands of parents with children having daily seizures who want all medical treatments explored, even those involving cannabis.
Epidiolex (cannabidiol) has been tipped as a potential blockbuster and the approval is the culmination of years of trials and development of the drug, which lacks the high associated with marijuana. Although a synthetic version of THC, marijuana's main psychoactive ingredient, has been legally available as a treatment for nausea and appetite loss since 1985, this is the first time the federal government has given its blessing to a medication derived directly from cannabis. The FDA noted, however, that it will still "take action" against the illegal marketing of CBD-containing products with unproven medical claims.
There is a form of CBD available at dispensaries in Texas but it is not covered by insurance.
Gottlieb emphasized that the approval of Epidiolex does not have any implications for the approval of marijuana as a medicine more broadly, but the move is still widely seen by the industry as a significant step towards acceptance of the cannabis plant.
The summer solstice in the southern hemisphere will occur on December 21, which is the winter solstice in the northern hemisphere. The summer solstice festival dates back thousands of years and is one of the most important dates in the pagan calendar.
Trade Representative on Friday released a list of almost 900 Chinese imports that will face a 25 percent tariff starting July 6 . The tariffs will also be applied to autos and aquatic products, the ministry said.
Avenatti went to social media to decry the attempt to take away his spotlight, tweeting: "We just learned that Mr. Avenatti's actions are mainly driven by his seemingly unquenchable thirst for publicity, ' it added.
Officials warned that gas emissions from Fissure 8 have doubled triggering air quality concerns, according to Hawaii News Now . A small explosion on the summit of Kilauea volcano has triggered an quake but there are no reports of damage.
This will enable 0-100km/h acceleration in "well under 3.5 seconds", Porsche says, with 0-200km/h coming up in under 12 seconds. With the lack of charging infrastructure, the chances of the Taycan coming to India anytime soon are nearly non-existent.
Neymar has sparked concern in Brazil after he was seen limping out of training ahead the side's World Cup clash with Costa Rica . But they have not beaten Germany in three attempts at various World Cups.
Pelosi was joined at the press conference in San Diego by ten other Democrats from California, including Rep. Many are fleeing violence in Central America and are hoping to apply for asylum in the United States.
They may also discuss efforts to recover the remains of soldiers missing and presumed dead from the 1950-53 Korean War. The two clasped hands for a long while Tuesday as they posed for photos in front of a row of US and North Korean flags.
It was a hard night for Messi and Argentina . "We are here to help him every moment, and of course we will be at his side". In Messi, Maxi Meza, Angel Di Maria and Aguero, Sampaoli arguably has the best attack at the World Cup .
But now they are up against Lionel Messi , a man who is on a mission to win his first trophy with the Argentine senior team. But the truth of the matter is, Argentina aren't a good enough side to go far in the tournament.
Erdogan declares victory in Turkish presidential poll
The CHP's presidential candidate Ince also accused election reports from the Anadolu Agency of "manipulation". More than 110,000 government workers have also been dismissed under a state of emergency after the coup.
Lewis Hamilton wins French Grand Prix to retake F1 lead
He stopped for new tyres on lap 33, momentarily losing the lead, before regaining it when Raikkonen stopped a lap later. He was into the points in 10th, passing Nico Hulkenberg on lap 12 but was already 24 seconds back from Hamilton.
Australia, Denmark draw 1-1
If the referee gives a crappy decision against you, you used to always say "you'll get that one back". Australia could face being eliminated if they lose to Denmark and France win against Peru later on.
Nigeria, S-Arabia, others disagree over oil supply
Iran is usually not part of the committee, which includes Russia, Saudi Arabia, the UAE, Oman, Kuwait, Algeria and Venezuela. Oil prices surged almost 75 percent, touching $80 a barrel, after OPEC and allies agreed to cut production in late 2016.
Russia on brink of knockout stage after win over Egypt
Mohamed Salah is facing an early exit from the World Cup after Egypt lost their second consecutive Group A game on Tuesday night. It will be scant consolation for the Egyptian King, however, as his talents are deserving of much more on the global stage.
1st session belongs to India -- thanks to Dhawan
It played at the ODI World Cup for the first time in 2015 and has already qualified for next year's championship in England . India will field an under-strength side in the one-off test as they have one eye fixed on the long worldwide schedule ahead.
Spain's Valencia to welcome migrants in days
Medicins Sans Frontiers said: "This plan would mean to people already exhausted to spend four more days on the sea". MSF called for a swift end to the crisis and a safe port in which to disembark the migrants .
Meghan Markle Calls Prince Harry the "Best Husband Ever"
Their first stop was the opening of the Mersey Gateway Bridge, including watching a performance by school children. You may have noticed that she was standing behind her sister-in-law , the Duchess of Cambridge Kate Middleton .
Meghan Markle Has A New In-House ‘Surprise Stylist’
The ceremony saw the royals come out in full attendance barring the absence of Prince Philip and the youngest royal Prince Louis . The official royal tour will be a rite of passage for royal newcomer Meghan, 36, as she settles into married life with Harry, 33.