tiptrot.com
tiptrot.com July 18, 2018


Attorney general Hill praises FDA efforts with cannabis-based drug

28 June 2018, 12:51 | Nichole Osborne

FDA approves first ever drug derived from marijuana | TheHill

Epidiolex a medicine made from the marijuana plant but without THC

As expected, the U.S. Food and Drug Administration on Monday approved GW Pharmaceuticals PLC-ADR (NASDAQ: GWPH)'s Epidiolex for the treatment of epilepsy, specifically for people who suffer with Lennox-Gastaut and Dravet syndromes.

It's not only the first cannabis-derived medicine to be approved by the FDA, but also the first approval for a drug created to treat Dravet Syndrome, a condition accompanied by hyperactivity, impulsiveness, autistic type behaviours and other developmental disorders as well as seizures. Though other drugs are approved to treat Lennox-Gastaut syndrome, Epidiolex is the first licensed to treat Dravet syndrome. It is a chemical component of the Cannabis sativa plant and does not cause the intoxication or euphoria that comes from tetrahydrocannabinol (THC).

Shaun Hussain, MD, a pediatric neurologist at Ronald Reagan UCLA Medical Center in Santa Monica, says that while the FDA's approval of a marijuana-based drug is "indeed a big deal", it is also significant because "it offers another drug for Lennox-Gastaut and the first-ever drug for Dravet".

Before sales of Epidiolex can begin, the DEA must formally reclassify CBD into a different category of drugs that have federal medical approval.


Dravet syndrome is a rare genetic condition that usually shows up in infants, starting with fever-related seizures and progressing to other, more severe seizure types. "These patient populations desperately need new treatment options to help control their seizures and the results of the clinical trial in both disorders are very promising". GW's subsidiary Greenwich Biosciences will market the drug in the US.

As part of Epidiolex's approval process, it must be rescheduled by the US Drug Enforcement Agency (DEA) from its current standing as a Schedule 1 drug, meaning it has no recognised medical use and a high potential for abuse.

The first-ever medical treatment derived from a marijuana plant will hit the USA market in a few months after regulators yesterday gave the epilepsy treatment the green light. "This should allow patients to have access to consistent cannabidiol doses made to the highest quality standards". "We'll continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims".

The drug set to be launched in autumn in the United States market is for treating rare and severe forms of epilepsy - Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients aged 2 and older. "It's being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits", Gottlieb said. Common side effects include sleepiness, elevated liver enzymes, decreased appetite, diarrhea, rash, and weakness.



Other News

loading...
loading...

Trending Now

DHS Secretary Kirstjen Nielsen briefs from White House
Senate in Texas, led a protest march to a temporary detention facility for immigrant children set up near El Paso. Secretary Nielsen tried to suggest the problem was with the Dept. of Health and Human Services, and not DHS.

Nigeria vs Argentina: Maradona seeks meeting with Messi, others
It will not be an easy game for Nigeria since Argentina have good players but confidence will be high in the camp of the African side.

Russia kick-starts campaign with a thumping win
On the break Zobnin drove forward and his shot was parried clumsily by Al-Mayoof as Saudi Arabia cleared the danger. Subs not used: Lunev, Semenov, Kudryashov, Granat, Aleksey Miranchuk, Anton Miranchuk, Erokhin, Smolnikov, Gabulov.

Harley-Davidson to build motorcycles destined for European Union outside of U.S.
Harley's filing follows a profit warning last week from Daimler AG, which cited escalating tensions between the US and China. Ramping up output in worldwide plants for the European Union may take at least nine to 18 months, according to the company.

First lady visits migrant children at Texas detention center
A White House insider said that the president is angry that the first lady made a decision to humiliate him. Trump wore the jacket as she boarded a flight en route to visit a group of migrant children in Texas.

Fox set to decide on Comcast’s $65-billion cash bid
Importantly, this also is $6.3 billion more than Comcast's all-cash offer earlier this month . In midday trading, shares of Fox rallied almost 7 percent to $47.21.

France Ready to Accept Migrants From Aquarius Ship Amid Standoff With Italy
French President Emmanuel Macron denounced the block on the Aquarius , insisting that Italy should have taken the migrants in. It added that Italy was waiting for French to take action to "heal the situation that has been created".

Serena Williams seeded 25th for Wimbledon
The 36-year-old American is continuing her return to action after giving birth to her first child, Olympia, in September 2017 . Simona Halep is No. 1 in the women's draw, with defending champion Garbine Muguruza at No. 3 behind Caroline Wozniacki .

Rampant Uruguay seal first place with easy win over ten-man Russian Federation
But Uruguay - with Suarez and Cavani leading the line - proved too strong for the World Cup hosts, doubling their lead on 23 minutes.

'Fixer Upper' stars Chip and Joanna Gaines welcome baby No. 5
Chip said Joanna is "doing great", and their newborn has "10 attractive toes and 10 handsome fingers". Joanna and Chip announced on social media that they were expecting another bundle of joy in January.