FDA Committee Recommends Approval For GW Pharmaceuticals (GWPH) Cannabis-Derived Drug

Wikimedia Commons

The larger implications for cannabis-based drugs are less clear, and researchers were measured about this opening the floodgates because of US restrictions on researching the compounds, as well as other illegal drugs that might have medical uses. Dronabinol, sold under the brand name Marinol, comes close, but is based on synthetic THC, and not cannabis plant-derived cannabinoids.

GW has gathered some impressive efficacy data on their drug, pitched to prevent seizures in children suffering from rare cases of Lennox-Gastaut syndrome and Dravet syndrome. The agency has indicated it would act by late June on the application from GW Pharmaceuticals, a British company that would market the drug. And, as Bloomberg, Reuters and other outlets reported, the drug seems to be working.

"It's an enormous milestone", Orrin Devinsky, who specializes in epilepsy at the New York University Langone Medical Center, said in an interview before the advisory panel meeting.

GW Pharmaceuticals offered "substantial evidence" to back Epidiolex's effectiveness, according to the FDA panel's report.

The timing is remarkable for a few reasons.

Salah ready for Real Madrid move - Mido
That being said, Real is in terrific form right now and has key player Cristiano Ronaldo who scores goals like it's no biggie. People can have their opinion; it doesn't bother me in the slightest.

Analysts had expected a positive advisory committee recommendation, and they also expect the drug to be prescribed off-label for other types of epilepsy if it is approved.

The Drug Enforcement Administration continues to classify marijuana as a Schedule I drug, meaning it has no proven medical value and a high risk of abuse.

Epidiolex is a plant-derived CBD extract, with some additives for flavor, that's taken orally in syrup form. It has less than 0.1 percent THC, and is now being considered to treat Dravet syndrome and Lennox-Gastaut syndrome, two very rare and usually untreatable forms of childhood epilepsy.

In trials, patients taking Epidiolex saw their monthly seizures reduced by about 40 percent. Several conservative states with draconian drug laws, including Texas, now allow severely ill people to access CBD oil, though with significant restrictions. The drugs, which are approved to treat nausea from chemotherapy and other conditions, are listed at Schedule III and Schedule II, respectively.

But it's also good for cannabis, which appears to be a medicine, according to agents of the USA federal government. Just as we all knew. "America clearly is moving, more so, and embracing cannabis as something that can be used medicinally".

Related News:



Most liked

Giants' GM expresses interest in Dez Bryant after releasing Brandon Marshall
Among those organizations, the New York Giants are the franchise Bryant singled out as having the most interest in joining . Gettleman will need close to $10 million in cap space to sign this year's draft class, according to Over the Cap .

Coli Outbreak Tied to Romaine Lettuce
Those most at risk for E. coli illness include the very young, the very old and individuals with compromised immune systems. More illnesses have been reported in connection with an E. coli outbreak linked to romaine lettuce .

Trump blamed the chemical attack on Syria and Russian Federation
The Syrian government and Russian Federation say the reports of a poison gas assault on the Syrian town of Douma are bogus. French President Emmanuel Macron said any strikes would target Syrian government chemical facilities.

The 6.1 Inch LCD IPhone Might Be Priced As Low As $550
DSDS tech is seen as key in some worldwide markets, such as China, where carriers can change depending on the province. A second version of the phone is expected as well with a traditional single-SIM design.

Allardyce tears into Everton fan survey
Everton boss Sam Allardyce says a survey sent to fans asking them to rate his performance on a scale of zero to 10 was "a marketing slip-up".

Updates on Most Active Stock: Caesars Entertnmt (CZR)
In looking the SMA 200, we see that the stock has seen an 13.71%.The Company's net profit margin for the 12-months at 0%. Long Pond Capital LP bought a new position in Caesars Entertainment during the fourth quarter worth $88,898,000.

Americans Waste One Pound Of Food Per Person Per Day
The estimates were compiled using data collected from various U.S. government databases, but it doesn't come without limitations. Researchers also found a correlation which is surprising at a first glance: healthy eaters waste more than unhealthy eaters.

Gov't to Investigate Korean Air Heiress's Past Executive Post
Lim has taken major cases involving celebrities including Park Yoo-chun's legal battle over alleged sexual assault in 2016. But Korean Air claims tempers rose when Cho discovered that footage she had requested had not been filmed.

Indiana Pacers vs Cleveland Cavaliers: 3 things we learned from Game 2
With the series shifting to Indianapolis , the duo of Oladipo and Darren Collison will look to be more opportunistic on offense. After Game 2, TNT's Ernie Johnson asked the Inside the National Basketball Association crew if the series would go seven games.

Microsoft Makes OneNote UWP Standard in Office 2019 for Windows
In fact, over the a year ago and a half we've added more than 100 of your favorite OneNote 2016 features based on your feedback. The biggest concern most OneNote 2016 users likely have is the loss of features when migrating to the Windows 10 version.

BJP Ministers quit Mehbooba Govt
However, a senior BJP leader said, "No resignation was accepted and all leaders were asked to resume work". Singh said he would not have resigned if the media had not created a negative perception about him.

Highlights of Analyst's Earnings Forecasts: Marathon Petroleum Corporation's (MPC)
During the past six months, Marathon Petroleum Corporation (NYSE: MPC)'s stock has been 39.35% and 57.41% for the last 12 months. Zeke Cap Advsr Llc holds 26,502 shares or 0.05% of its portfolio. 200 were reported by Tower Rech Cap Limited Liability (Trc).

Moto E5, E5 Play and E5 Plus announced
As far as software goes - you get Android 8 Oreo out of the box and, hopefully, Motorola's well-known timely updates afterwards. Just a few days ago Honor released the Honor 7A and the Honor 7C, and, like the Moto G6 , the £140 7C has an 18:9 screen.

Giancarlo Stanton's ex-manager is unsure how boos will affect star
When asked how he can win over his critics, Stanton said: "Keep working". Boone said: "That's a matter of time and just getting settled in.

Canada central bank maintains key lending rate at 1.25%
A sign is pictured outside the Bank of Canada building in Ottawa, Ontario, Canada, May 23, 2017. The Canadian Dollar was a fraction lower against all other developed world currencies.