FDA approves 1st marijuana-based prescription drug

Share
FDA approves 1st marijuana-based prescription drug

For the first time, the U.S. Food and Drug Administration has approved a medication derived from marijuana.

The FDA approval for Epidiolex is technically limited to patients with Dravet and Lennox-Gastaut syndromes, two rare forms of epilepsy for which there are few effective treatments.

Today's approval "serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies". "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 drug is derived from the cannabidiol of cannabis, and, as the plant is yet to be decriminalized by federal regulators, its approval gives GW Pharma a lead among cannabis-exposed companies in the US financial markets. CBD is one of more than 100 chemicals found in marijuana. GW Pharmaceuticals grows the plants in the United Kingdom. The drug reduced seizures by half in 40 percent of Dravet patients participating in the trials. "If the FDA makes it clear that a cannabis-based pharmaceutical drug has medicinal value, then Congress can no longer claim there is no medicinal quality for cannabis". 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. He would not give any information on cost, saying only that it will be discussed with insurance companies and announced later. Epidiolex had previously received Fast Track Designation and Orphan Drug Status from the FDA.

Most patients with LGS and Dravet syndrome require multiple seizure medications and the majority are resistant to now approved anti-epileptic drugs. The chemical's use in seizure prevention is well-documented in reputable research, and now, after conducting its own trials, the FDA is on board.

Relying on homemade oil "is is a awful system, creating products that likely have more variability and can potentially contribute to more side effects and less consistency", Devinsky said. 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. There was some concern about the drug's effects on the liver, but experts have said this risk could be addressed by doctors as they monitor their patients during treatment.

The European Medicines Agency is now reviewing Epidiolex for treating seizures associated with LGS and Dravet Syndrome, with a decision on whether or not to recommend approval expected early next year.

A phase three clinical trial is underway for a third seizure-related condition called tuberous sclerosis complex, which begins in infancy and causes a sudden stiffening of the body, arms and legs, with the head bent forward. GW won't be able to market Epidiolex until the DEA reclassifies CBD.

As part of the FDA's review of the medication, the potential for abuse was assessed and found to be low to negative, according to Gover.

Despite today's approval, the FDA acknowledged in a statement that the cannabidinoid CBD still remains classified at this time as a schedule I controlled substance, and that the agency is "prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims".

Share

Advertisement

Related Posts

Teenage soccer team feared trapped in Thai cave
He said footprints and handprints were found inside the cave complex and that officials believe the boys are still alive.

Welcome to the club! Cavani joins Suarez in Uruguayan goalscorer record
It went from bad to worse for Russian Federation as they were reduced to ten men before the interval. We are satisfied with what the team did, we've already said this in previous press conferences.

Clinical Federer beats Kudla to set up Coric final in Halle
In the second set, Ebden broke Federer twice and served for the set at 5-4 only for the Swiss to break back for a second time. His famous one-handed backhand was on fire, striking down winners and passing shots from all corners of the court.

Denmark, Australia face-off in crunch Group C clash
It never came, leaving the Socceroos to depart the raucous stadium to a standing ovation but just one point from their two games. Danish players speak to the referee after VAR is used to award a penalty to Australia .

Messi is frustrated and hungry - Mascherano
Presumably though, Sampaoli will be sacked if Argentina do not make it out the group, a fate they are desperate to avoid. But Argentina is still a slight favorite to advance as the runner-up in Group D after Nigeria beat Iceland on Friday.

Celebrities mourn the death of DBanj’s son, Daniel
A former labelmate and producer, Don Jazzy, wrote, "Just heard the worst news in a long time". 'My condolences I wish you'. Some musicians have commiserated with popular singer, Daniel Oyebanjo, a.k.a Dbanj , over the death of his son, David Jnr.

Trump urges turning away immigrants, Congress struggles
By Friday, however, he tweeted that Republicans should stand down until after midterms because of obstruction from Democrats. Trump's daily lack of civility has provoked responses that are predictable but unacceptable.

Apple rumored to launch high-end AirPods, over-ear headphones next year
Additionally, Apple is rumored to be working on a wireless charging case that works with the upcoming AirPower charger . Finally, the report claims that there is a new HomePod smart speaker on the way.

Xbox One will soon play nice with keyboards and mice
The presentation noted that the mouse and keyboard support for the Xbox One would arrive with April update this Fall. Developers would be able to customize the visibility and appearance of the mouse pointer in Xbox One titles as well.

New Bug Uncovered by Security Researcher Allows iPhone Passcode to be Hacked
Once the iPhone is plugged, the hacker bombards the device with different combinations of the passcode. So while it looks like the pins are getting tested one after the other, the codes aren't always sent .

© 2015 ExpressNewsline. All Rights reserved.