FDA Approves First Marijuana-Derived Drug

FDA Approves First Marijuana-Derived Drug

USA health regulators on Monday approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use.

Dravet syndrome is a rare genetic condition that causes frequent fever-related seizures, involuntary muscle spasms and a potentially life-threatening state of continuous seizure activity requiring emergency medical care. Though other drugs are approved to treat Lennox-Gastaut syndrome, Epidiolex is the first licensed to treat Dravet syndrome.

"Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes", Gottlieb said.

"Sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies", FDA Commissioner Dr. Scott Gottlieb said in a statement released Monday by the agency.

He said there are thousands of parents with children having daily seizures who want all medical treatments explored, even those involving cannabis.

The FDA took pains to specify that clearing Epidiolex for use is not an approval of marijuana or any of its components. Almost all patients with these conditions continue to have daily seizures-some having multiple per day-despite the use of legally available drugs. Similar results were reported in a Phase 3 placebo-controlled trial among 171 patients with Lennox-Gastaut syndrome published this year in the Lancet.

Carlos Queiroz: VAR doesn't work
Carlos Queiroz also hit out at Iran and Spain referee Andres Cunha, saying the Uruguayan's decisions went against Team Melli . Ronaldo has now missed six of his last 14 penalty kicks, but he wasn't the only big star to miss one in this tournament.

Can Argentina qualify for the last 16?
Serbia must beat Brazil to qualify but a draw could see them through if the Swiss are beaten by Costa Rica by more than one goal . In order for Australia to qualify they must beat Peru , hope Denmark lose and also better the Danes' goal difference.

Harley-Davidson warns European tariffs will cause a 'tremendous cost increase' (HOG)
Trump has regularly pointed to Harley-Davidson as an example of a USA business harmed by trade barriers. It has three assembly plants outside the United States - one each in Brazil, India and Thailand.

Federal agencies have 90 days to determine the scheduling of Epidiolex.

But although the green light means that patients will soon be able to access Epidiolex with a doctor's prescription, many will also likely turn to less expensive sources of CBD, such as those sold in marijuana dispensaries.

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.

"Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others", the FDA said. But marijuana products in general are subject to Schedule I restrictions by the Drug Enforcement Administration (DEA) because of the potential for abuse.

A new drug derived from marijuana just became the first of its kind to get the green light from the USA government. "However, it remains to be seen whether physicians will be comfortable prescribing this new agent to those patients who may benefit from it, and whether it will be priced in a range that patients may afford". Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy. And like other drugs that treat epilepsy, Epidiolex will come with a special warning that use may be tied to a higher odds of depression, aggression and suicidal thoughts.

Related news:

Hot News

isis-killer-beheading-video-story-top Breaking into World Cup club all in the mind for Belgium
Jun 27, 2018 - 03:24
Maybe the two tournaments were a bit different where we arrived and we were thinking about what was going to happen. Football is all about having fun - but playing to win at the same time".

Iceland crash out after Croatia loss
Jun 27, 2018 - 03:10
Croatia showed none of that lethargy to start the second half, however, and it was in the 53rd minute when Badelj broke through. Sverrir Ingason forced Kalinic into another spectacular save seconds before his header shaved the top of the bar.

isis-killer-beheading-video-story-top Marvel Studios President Kevin Feige Says LGBTQ Characters Headed to MCU
Jun 27, 2018 - 02:46
Gwyneth Paltrow said the same thing after her first time suiting up for Iron Man 3. "I think it's become an Ant-Man tradition. And it made me feel like a superhero".

Peru coach Ricardo Gareca may quit after World Cup exit
Jun 27, 2018 - 02:36
Neither side could find another opening in the final 10 minutes as Peru went into the break with a slight advantage. A free kick looking for Guerrero in the 24th minute was not enough as his header was easily picked up.

isis-killer-beheading-video-story-top Maradona shows middle fingers on camera as Argentina score winner
Jun 27, 2018 - 01:27
On Tuesday they will all be cheering him on as Australia take on Peru in Group C in Sochi in a bid to qualify for the last 16. Australia need France to beat Denmark, however Behich said all the focus was on Peru .

isis-killer-beheading-video-story-top Christensen Feels Pressure Heading into Crunch World Cup Tie for Denmark
Jun 27, 2018 - 01:10
"We know that we failed in attack, but if I may, for a really good match, there needs to be two teams wanting to play football". But with the Peruvians leading 2-0 before the hour in that game, the Moscow clash settled down to little more than a canter.

isis-killer-beheading-video-story-top Spain snatches late draw with Morocco to reach World Cup knockout round
Jun 26, 2018 - 08:54
The Yeni Malatyaspor striker raced clear and slid the ball through the legs of David De Gea to hand Morocco the lead after 14 minutes.

isis-killer-beheading-video-story-top Pompeo: No timeline for North Korean denuclearization
Jun 26, 2018 - 07:02
The two signed a document calling for, among other things, efforts to remove nuclear weapons from the Korean Peninsula. The official went on to say the USA will soon know whether or not Kim Jong Un plans to stick with the agreement.

isis-killer-beheading-video-story-top Supreme Court Refuses Anti-Gay Florist’s Case - For Now
Jun 26, 2018 - 06:37
He argued that the Supreme Court had "passed on a huge opportunity to improve justice, especially for juveniles". Supreme Court has declined to take up the case of HBO's Making a Murderer subject Brendan Dassey .

isis-killer-beheading-video-story-top VAR drama, Neymar breaks down in dramatic win
Jun 26, 2018 - 05:43
Tite also said he would use the same 11 players that were held to a 1-1 draw by Switzerland in the team's opening match. It might have been more, but a penalty won in dubious circumstances by the PSG forward was overturned by VAR.

isis-killer-beheading-video-story-top US Says Still Working to Reunite 2053 Children with Families
Jun 26, 2018 - 05:18
Goodlatte's bill has no avenue to green cards or citizenship, just temporary protective status that is renewed every three years. Both bills offer protections to DREAMers, folks brought illegally into the U.S.as kids.

isis-killer-beheading-video-story-top Apple plans new, improved AirPods, HomePod and over-ear headphones
Jun 26, 2018 - 04:38
The report has a new HomePod , updated high-end AirPods, and all-new over-ear headphones shipping at some point in 2019. Thus far, the company has used Inventec and Luxshare Precision for manufacturing but it has struggled to meet demand.

isis-killer-beheading-video-story-top Jared Kushner: U.S. to release Palestinian-Israeli peace plan soon
Jun 26, 2018 - 04:13
As Trump's policies appear to favor Israel more than those of his predecessor Barack Obama, Abbas has resisted, saying the U.S. Britain's Prince William kicked off a politically delicate five-day tour of Jordan, Israel and the Palestinian territories.

isis-killer-beheading-video-story-top Petit: Messi is not a leader like Ronaldo
Jun 26, 2018 - 04:04
In two World Cup games, the only constant has been the fact that Argentina can not get out of its own way. Argentina must now beat Nigeria in their final Group D match and hope other results go their way.

isis-killer-beheading-video-story-top Woman's selfies capture moving lump on face: a parasite
Jun 26, 2018 - 03:41
The treatment for a Dirofilaria repens infection is actually quite simple, as the worm will simply have to be surgically removed. Next, the lump migrated to the left side of her upper lip, causing her to have lopsided swelling in that area.