FDA Approves Marijuana-Based Epilepsy Drug

FDA Approves Marijuana-Based Epilepsy Drug

The approval was granted to Greenwich Biosciences, the U.S. subsidiary of GW Pharmaceuticals, for Epidiolex, an oral solution of purified cannabidiol (CBD).

This has always been a concern of Indiana Attorney General Curtis Hill, who has been outspoken against the use of marijuana and marijuana derivatives to treat illness in the past calling it a "gateway drug".

FDA commissioner Scott Gottlieb has said that it is committed to this kind of careful scientific research and drug development making these kinds of important medical advances.

The North American Marijuana Index closed mixed on Tuesday following this week's news that GW Pharmaceuticals (NASDAQ:GWPH) won FDA approval for their CBD-based drug Epidiolex. "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". The FDA noted, however, that it will still "take action" against the illegal marketing of CBD-containing products with unproven medical claims.

Some adults with Angelman experience a type of myoclonic activity - involuntary muscle spams - that is not formally considered a seizure, but can cause debilitating tremors and muscle contractions, Bichell said. Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur.

Both Lennox-Gastaut syndrome and Dravet syndrome arise in childhood, often leading to development problems.

The article does not state exactly when the drug will be on the USA market, but generally, FDA approval coincides with market availability.

The FDA's approval of this drug is highly newsworthy and will be of great interest not only for those seeking help for the rare seizure disorders the new drug, Epidiolex, is meant to treat, but also for other diseases and symptoms such as pain and nausea. The drug was found to be effective in reducing the seizure frequency when taken with other medications as compared to placebo. Access is expected to be similar to other branded AEDs, and EPIDIOLEX® is expected to be available to appropriate patients by Fall 2018.

Dr. Shinnar believes the drug was carefully chosen, in light of the severe conditions it can help treat. Epidiolex may also cause liver injury, though generally mild. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition.

Currently, CBD-as with other marijuana components-is classified as a Schedule I drug by the DEA.

Rite Aid told CNNMoney it would sell Epidiolex once the DEA schedules it.

The FDA granted Priority Review designation for this application. The fast-track designation was granted for Dravet syndrome.

"The same principles around any prescription medication can now be applied to cannabis-based medications", GW Pharma Chief Executive Officer Justin Gover said in an interview before the FDA's decision.

At the CU Skaggs School of Pharmacy, there are now a few drugs being tested - one for seizures and the other for Parkinson's tremors that are both are derived from cannabis.

Related news:

Hot News

isis-killer-beheading-video-story-top Woman calls police on little girl selling water outside apartment building
Jun 28, 2018 - 11:00
She said that she didn't close the windows of her office because it was too hot and that it wouldn't have stopped the noise. She was filmed calling the police on an African American family who was barbequing at a nearby lake.

isis-killer-beheading-video-story-top Bentley Bentayga Pikes Peak Limited Edition celebrates Pikes Peak record run
Jun 28, 2018 - 09:19
The front seats were replaced with racing items, while the rears were removed to make way for a roll cage. "The Volkswagen I.D. Inside the Pikes Peak Bentayga, Key Lime accents mesh with Beluga leather, Alcantara, and an Eliade cloth headliner.

isis-killer-beheading-video-story-top Book award drops Laura Ingalls Wilder's name over her lack of 'inclusiveness'
Jun 28, 2018 - 09:15
In " Little House on the Prairie ", Wilder wrote, "Their Faces were bold and fierce and bad ". The award's name has since been changed to the Children's Literature Legacy Award.

isis-killer-beheading-video-story-top Justice Anthony Kennedy Retiring From the Supreme Court
Jun 28, 2018 - 07:28
Conservative activists have already announced their intention to use a more conservative court to overturn the 1973 Roe v. A Supreme Court with someone like Roberts in the ideological middle would not be unprecedented.

isis-killer-beheading-video-story-top ‘Pressure mounting’ on Lakers to trade for Kawhi Leonard
Jun 28, 2018 - 06:28
On the other hand, the Lakers are apparently feeling pressure to find a way to lure James or George (or both) to Los Angeles. One agent recently suggested to Business Insider that the Spurs should not trade Leonard, barring a mega-offer.

isis-killer-beheading-video-story-top Brazil beat Serbia to book date with Mexico in round of 16
Jun 28, 2018 - 05:45
But Paulinho , the player that Tite calls his "secret weapon", lived up to his name by scoring the first goal at Spartak Stadium . Brazil had an early setback when left back Marcelo was substituted in the 10th minute, limping off the field.

isis-killer-beheading-video-story-top Apple Is Said to Amplify Its Audio-Device Strategy in 2019
Jun 28, 2018 - 05:15
You won't be swimming in them though: The water resistance is mainly to protect against rain and perspiration, the people said . A spokesperson for Apple declined to comment on the leaked information.

isis-killer-beheading-video-story-top Hernandez nets as Mexico see off South Korea
Jun 26, 2018 - 18:37
However, that left them exposed at the back, where El Tri pounced on the counterattack on a few occasions. Mexico are joint top of group F with Sweden, who beat South Korea 1-0 in their first game.

isis-killer-beheading-video-story-top Trump adviser Kushner says he's 'ready to work' with Abbas
Jun 26, 2018 - 17:14
He said his wife was "very sorry" she was not able to join him on the trip so soon after the April birth of their son, Louis. The Palestinian leader, Kushner said, "says that he is committed to peace, and I don't have any reason to disbelieve him".

isis-killer-beheading-video-story-top Could Moe Wagner Be Headed to the Lakers?
Jun 26, 2018 - 16:50
The draft is only a few minutes from getting underway and there could be a little more clarity once it's over. The Charlotte Hornets' Kemba Walker has quietly evolved into one of the league's best point guards.

isis-killer-beheading-video-story-top North Korea Limits Family Reunions
Jun 26, 2018 - 16:09
In a statement, a U.D. official said the timeline will clarify what the implementation of the summit agreement should look like.

isis-killer-beheading-video-story-top Kyrgios Queen's quest ends, Wimbledon next
Jun 25, 2018 - 03:47
The heat was sweltering and in the next game there was a stoppage as a member of the crowd required help from the medical team. Cilic was on the verge of a third loss in the Queen's final when Djokovic held a match point in the second set.

isis-killer-beheading-video-story-top Who wins Group G if England and Belgium draw?
Jun 25, 2018 - 00:11
The first goal came from Manchester City defender John Stones on eight minutes, who scored his first ever global goal. Kane is now one goal ahead of Cristiano Ronaldo and Romelu Lukaku in the battle to be crowned top scorer.

isis-killer-beheading-video-story-top Erdogan leads in Turkey’s presidential election - preliminary results
Jun 24, 2018 - 23:17
In the parliamentary contest, the AK Party had 53.03 per cent, based on 10.25 per cent of votes counted, the broadcasters said. To achieve an outright victory and avoid a second round, Erdogan needs to secure more than 50 percent of the vote.

isis-killer-beheading-video-story-top An *Interview* With Blue, A Chill Velociraptor From ‘Jurassic World: Fallen Kingdom’
Jun 23, 2018 - 13:33
What did Chris Pratt , Bryce Dallas Howard , Jeff Goldblum , Justice Smith , Daniella Pineda , and director J.A. The Park is gone, but the money is still there for the Jurassic franchise.