FDA Approves Medicine Containing Cannabis for the First Time

Norman Posselt—Getty Images  fStop

The chemical used in Epidiolex, cannabidiol, is a component of the cannabis sativa plant, but does not carry the same psychoactive effects or "the high" that results from pure tetrahydrocannabinol (THC) consumption.

"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", said Justin Gover, GW's Chief Executive Officer.

The move marks several firsts.

The approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle.

New approved drug is syrup-like medicine, which contains cannabidiol (CBD) as an active ingredient.

FDA Commissioner Scott Gottlieb issued a separate statement stressing the importance of proper research on medical uses of marijuana and cautioning other companies that might try to push their pot treatments.

"This is the first time the government has approved a compound derived from the cannabis plant to treat any disorder - in this case, severe epilepsy due to Dravet and Lennox Gastaut syndromes".

The drug's effectiveness was studied in clinical trials with 516 patients and when taken with other medications, Epidiolex was shown to be effective in reducing the frequency of seizures when compared with placebo.

"This research process - from early development through preclinical and clinical research - gives us a comprehensive understanding of a new drug", he said.

Russian Federation carries out first air strikes in south Syria ceasefire zone
The message also told the rebels that the decision on how to face the Syrian army's military action was up to them. The bombardment has killed about 30 people since it began on 19 June, the Observatory reported.

Erdogan's election victory praised around world
Perhaps the most surprising result from the election was the success of the MHP, who are in a political coalition with the AKP. The CHP said it had recorded violations in particular in the southeastern province of Sanliurfa.

EU's Juncker says backing of Irish Brexit position will not change
It remains our intention to achieve a close economic partnership that does not require the backstop to be in operation". Now we're seeing the consequences of kicking every tough decision into the long grass.

If experts are to be believed, Epidiolex is key breakthrough by GW Pharmaceuticals - one that is likely to aid hundreds of children suffering from epilepsy.

Epidiolex is reportedly an oral solution meant to treat seizures that are known to be associated with two particular types of epilepsy, the Lennox-Gastaut syndrome, and Dravet syndrome, for children 2 years old and above.

More than 90 percent of patients with LGS or Dravet syndrome have multiple seizures per day, which puts them at constant risk for falls and injury.

It's an option for those patients who have not responded to other treatments to control 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.

The most common side effects of Epidiolex include diarrhea, rash, insomnia, and infections.

"And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition", he continued.

The company has not announced pricing for the drug, but Wall Street analysts previously predicted it could cost as much as $25,000 per year.

"The DEA will need to make a different scheduling decision for CBD.because it now has an accepted medical use", he said during a conference call with reporters.

Related news:

Hot News

isis-killer-beheading-video-story-top Serena Williams victorious: Wimbledon amends rules to grant her 25th seed
Jun 28, 2018 - 00:44
Opens - has the prerogative to depart from the rankings in awarding its 32 seeds to ensure a balanced, 128-player field. The tennis great said earlier this week that pregnancy should not be penalized when it comes to tournament seeding.

isis-killer-beheading-video-story-top European Union must cooperate on migration: commissioner
Jun 28, 2018 - 00:30
Even though new arrivals have dropped, the political consequences of migration pressures are still reverberating around Europe. In recent weeks, Italy's new populist government has cracked down on foreign rescue ships operating in the Mediterranean.

isis-killer-beheading-video-story-top Uruguay beat hosts Russia 3-0
Jun 28, 2018 - 00:18
Akinfeev makes the save to prevent a header Godin finding the net, but Cavani was on hand to bundle home the rebound. Both through to the Round of 16, there was no need for either team to exert itself overly on a hot, sticky evening.

isis-killer-beheading-video-story-top LeBron James’ son likely to enroll in L.A. high school
Jun 28, 2018 - 00:16
If not, they presumably would need to part with significantly more assets in order to acquire Leonard. Organizations won't offer as much value for Leonard if they know he will be only a one-year rental.

isis-killer-beheading-video-story-top Migrating bump on woman's face turned out to be a worm
Jun 26, 2018 - 03:21
Doctors determined that the wandering wart was actually a marauding parasite, likely transmitted by a mosquito bite on her trip. She didn't pay attention to it, at first, but she started posting pictures of the bump of her social media channel just in case.

isis-killer-beheading-video-story-top OPEC agrees ouput rise of ‘about’ 1 million barrels
Jun 26, 2018 - 01:48
Much of the current production shortfall has come from Venezuela, where an economic crisis has savaged petroleum production. OPEC is responsible for about 40 percent of the world's oil production and more than 80 percent of established oil reserves.

isis-killer-beheading-video-story-top Egypt's Essam El-Hadary Makes World Cup History
Jun 26, 2018 - 01:43
Salah is also clearly not fully fit, but managed to score two goals in his two appearances, one from the penalty spot. Egypt goalkeeper Essam El Hadary , who is 45, took the field for his team's final group match to set the record.

isis-killer-beheading-video-story-top Melania Trump speaks at youth empowerment event
Jun 26, 2018 - 01:28
Later Thursday afternoon, Grisham tweeted: Today's visit w the children in Texas impacted [the first lady] greatly. She said that she cried when the two were reunited and that she is never going to be away from him again.

isis-killer-beheading-video-story-top U.S. Extends Sanctions Against North Korea, Citing 'Extraordinary Threat'
Jun 24, 2018 - 10:33
In total, more than 36,500 USA troops died in the conflict. "We need to closely watch North Korea's steps toward denuclearisation".

isis-killer-beheading-video-story-top Instagram competes with Youtube, launches IGTV
Jun 24, 2018 - 10:25
The first is a new milestone for the Facebook-owned social network as Instagram revealed it now has 1 billion users worldwide. People wanting to watch a one hour video on their TV, for instance, won't enjoy wasted screen real estate and black bars.

isis-killer-beheading-video-story-top Amazon.com, Inc. (AMZN) Prime Day Date Leaked
Jun 24, 2018 - 10:06
As usual we'll have all the best deals up on site, so you don't have to go sifting through them all for yourself. Amazon "Prime" subscriptions cost $119 annually, up from the original $99 price tag after a fee hike in May.

isis-killer-beheading-video-story-top Dele Alli has 'slim chance' of playing against Panama, confirms Southgate
Jun 24, 2018 - 10:04
Hopes will be high at least one of his colleagues can hit the target against Panama to reduce the reliance on a single source. There is no physiological benefit to train in the heat for a couple of weeks before and thinking there will be an adaptation.

isis-killer-beheading-video-story-top How ESPN Ruined The 2018 NBA Draft
Jun 24, 2018 - 09:42
Despite Ayton's confidence heading into the draft , he said he was nervous before the Suns' pick was announced Thursday evening. But the Pac 12, which had Arizona's Deandre Ayton taken No. 1 overall, matched its three NCAA teams with three draft picks.

isis-killer-beheading-video-story-top Chip and Joanna Gaines welcome 5th child
Jun 24, 2018 - 09:42
Chip and Joanna Gaines' family just got a little bigger. Thank you for all your thoughts and prayers. The baby boy's name has not been announced.

isis-killer-beheading-video-story-top USA to stop prosecuting parents who cross border illegally with children
Jun 24, 2018 - 09:36
The warehouse-like facility has holding pens made from chain-link fences on the inside separating the immigrants . De Blasio said staff members reported seeing about 350 children since the launch of the "zero tolerance" policy.