FDA Approves GW Pharma's Epidiolex

28 June, 2018, 11:22 | Author: Lynne Higgins
  • FDA approves first ever drug derived from marijuana | TheHill

GW Pharmaceuticals' Epidiolex has become the first cannabinoid prescription medicine to be approved in the United States, winning clearance to treat two rare forms of epilepsy.

Billy Dunn, M.D., director of the Division of Neurology Products at the FDA's Center for Drug Evaluation and Research, said: "The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients' quality of life". It's a CBD oil used to treat two rare types of epilepsy most often found in children.

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. Outside the US, this medicine is now under review by the European Medicines Agency (EMA) for the treatment of seizures associated with Dravet Syndrome and LGS.

Cannabidiol (CBD) is one of the most abundant compounds in the marijuana plant.

Most patients with LGS and Dravet require several drugs and are resistant to many now approved epilepsy drugs. As it stands, the article offers no information at all about reduction in seizures of those who take the drug, or a basis for which to compare its value to other treatments for severe epilepsy. The FDA noted in its announcement today that it informs and advises the DEA about scheduled substances. Common side effects include sleepiness, elevated liver enzymes, decreased appetite, diarrhea, rash, and weakness.

GW is also developing Epidiolex in tuberous sclerosis, and if approved in the third indication, sales could break through the billion dollar annual sales barrier.

Marin Cilic and Novak Djokovic set for Queen's final after semifinal wins
The Serb returned superbly to force a match point but the Croatian fended it off with some big-serving. He then served it out to love to claim his second title at Queen's.

The FDA has previously approved synthetic versions of another cannabis ingredient for medical use, including severe weight loss in patients with HIV. The company has not yet set a price for the drug and said it would work with insurance providers to ensure the medicine would be covered under health plans.

Justin Gover, CEO of GW Pharmaceuticals, the UK-based company behind the drug, said the approval signals "validation of the science of cannabinoid medication". Indeed, the FDA has been trying to crack down on CBD producers who make claims that their products can cure diseases like cancer.

As part of the approval process, EPIDIOLEX must be rescheduled from its current Schedule I before it can be made available to patients.

"It's time that we start taking a look at the marijuana plant, the cannabis derivative, and trying to find medical uses for it", he said to Maria Bartiromo on "Mornings with Maria". Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.

In order to obtain FDA approval for this specific drug targeting two particular medical conditions, GW Research Ltd. evaluated Epidiolex's efficacy and safety in three randomized, double-blind, placebo-controlled clinical trials.

Recommended:



Popular

'Permit Patty' calls cops on girl selling water in San Francisco
Ettel was also set to be one of the subjects of a documentary called Lady Buds , a film about women in the cannabis industry. She then approached the mother and daughter and said that she politely, but sternly, asked them to keep it down.

Where are the best places to see the upcoming 'blood moon'?
The Strawberry Moon will spectacularly light up the night skies of Thursday, June 28, when it reaches its full moon phase. Saturn is at "opposition", meaning the planet and the sun are on opposite sides of the Earth, according to NASA .

Apple working on noise-canceling AirPods
When the earbuds first came out in 2016, they were delayed, and there was limited supply after the product finally went on sale. An in-house audio product team is run by Gary Geaves, formerly an engineer from B&W, a maker of speaker systems and headphones.

Real Madrid starlet Marco Asensio hints at potential Liverpool move
The tale looks like will follow the path of Van Dijk's transfer saga and is resulting into unsettlement in Liverpool's fan base.

Mexico Sinks South Korea, Stay Perfect At 2018 World Cup
In its first Group F game, South Korea was unable to find the back of the net in a 1-0 loss to the group's co-leader in Sweden . However, that left them exposed at the back, where El Tri pounced on the counterattack on a few occasions.

Prince William arrives in Jordan as he starts historic Middle East tour
It also accused him of engaging in "deception" against worldwide law and "promoting normalization" between Arabs and Israel. The White House issued brief, near-identical statements after their stops in Jordan, Egypt, Saudi Arabia, Qatar and Israel.

Senegal, Japan play out exciting draw
Our team has the quality to face Colombia", he added, looking forward to Thursday's meeting with the South Americans in Samara. Japan coach Akira Nishino said he thought his defenders did a "pretty good job" on Mane. "I have confidence.

Spider-Man: Homecoming Sequel Title Revealed by Tom Holland
I'm a little confused because, um, I died, so I don't really know how it all comes into play but... The upcoming MCU film stars Tom Holland , Marisa Tomei, Michael Keaton and Zendaya.

Saudi Arabia lifts ban on women drivers
The number of new drivers remains low, as women with foreign permits were only able to convert them starting this month. Many Saudis celebrated on social media, but some reactions were derisive or expressed concern about the social impact.

Saudi Arabia take positives for Asian Cup after Russian Federation exit
Uruguay have lost just one of their last nine World Cup group games, While in last six games they have won five out of them. Uruguay as a team weren't particularly impressive, either, as their play was often slow and lacking in spark or intensity.