FDA Approves First Drug Derived From Marijuana Plant

[DamianTV]

https://science.slashdot.org/story/...roves-first-drug-derived-from-marijuana-plant

The U.S. Food and Drug Administration on Monday approved the first prescription drug derived from the marijuana plant, as a treatment for rare forms of epilepsy that primarily afflict children. From a report:

The FDA said Monday that it cleared GW Pharmaceuticals's Epidiolex, also known as cannabidiol, to reduce seizures associated with forms of epilepsy known as Lennox-Gastaut syndrome and Dravet syndrome, in patients 2 years of age and older. Cannabidiol is derived from the cannabis plant, also known as marijuana. U.K.-based GW Pharmaceuticals says the solution, taken by mouth, is made from a proprietary strain of cannabis designed to maximize a therapeutic component while minimizing components that produce euphoria. GW Pharmaceuticals grows the plants in the U.K.

The FDA said Monday that the drug doesn't cause the high that comes from the chemical tetrahydrocannabinol, or THC, which is the main psychoactive component of marijuana. FDA officials also said the drug doesn't appear to have abuse potential, citing minimal reports of euphoria in patients who took the drug in clinical studies.​

Further reading: StatNews, The Guardian, and FDA.

 

[RonZeplin]

Pending DEA approval, dragging the stock price down

FDA Approves Cannabis-Based Drug, But GW Tanks As It Awaits DEA Nod

GW Pharmaceuticals (GWPH) tanked Monday after U.S. officials approved its cannabis-based seizure drug, but said it will have to wait to market the treatment until after the Drug Enforcement Administration scrutinizes the treatment.

On the stock market today, GW shares toppled 4.3%, to wrap the day at 144.76. Earlier, shares fell as much as 6.1%. Meanwhile, shares of rival Zogenix (ZGNX) dipped 3.2%, to 43.25.

The share movement came just after the Food and Drug Administration approved GW's drug. The drug, called Epidiolex, is now approved to treat children as young as two with seizure disorders called Lennox-Gastaut syndrome and Dravet syndrome.

GW Chief Executive Justin Gover noted "many years" of work go into the approval.

"Today's approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved (cannabidiol) medicine to treat two severe, childhood-onset epilepsies," he said in a written statement.

First CBD Drug Approved

Epidiolex is derived directly from the cannabis plant. It contains cannabidiol, or CBD, rather than tetrahydrocannabinol, or THC. THC is the chemical responsible for marijuana's euphoric high. GW calls Epidiolex the first in a new category of anti-epileptic drugs.

But that means the DEA will have to reschedule Epidiolex from its current Schedule 1 status. These are drugs the DEA deems to have no medicinal use and a high potential for abuse. The rescheduling can occur within 90 days. GW can't sell Epidiolex before then.

"This suggests the launch is unlikely to occur until (the fourth quarter of 2018)," Janney analyst Ken Trbovich said in a report. "GW has indicated this is not a concern since it will hire and train its field sales organization during this time."

Trbovich notes Epidiolex could soon have competition from Zogenix. In September, Zogenix reported strong results from a Phase 3 study of its Dravet syndrome treatment. The drug reduced monthly convulsive seizures by 72% compared to 17% for those on the placebo, he wrote.

"While acknowledging there are no head-to-head studies and there are significant differences in patient populations between the Zogenix and GW Dravet studies, consider that Epidiolex showed a 39% reduction in seizures vs. 13% for placebo in its Phase 3 Dravet study," he said.

Trbovich has a sell rating on GW stock.

 

[dannno]

FDA Approves Cannabis-Based Drug, But GW Tanks As It Awaits DEA Nod

GW Pharmaceuticals (GWPH) tanked Monday after U.S. officials approved its cannabis-based seizure drug, but said it will have to wait to market the treatment until after the Drug Enforcement Administration scrutinizes the treatment.

On the stock market today, GW shares toppled 4.3%, to wrap the day at 144.76. Earlier, shares fell as much as 6.1%. Meanwhile, shares of rival Zogenix (ZGNX) dipped 3.2%, to 43.25.

The share movement came just after the Food and Drug Administration approved GW's drug. The drug, called Epidiolex, is now approved to treat children as young as two with seizure disorders called Lennox-Gastaut syndrome and Dravet syndrome.

GW Chief Executive Justin Gover noted "many years" of work go into the approval.

"Today's approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved (cannabidiol) medicine to treat two severe, childhood-onset epilepsies," he said in a written statement.

First CBD Drug Approved

Epidiolex is derived directly from the cannabis plant. It contains cannabidiol, or CBD, rather than tetrahydrocannabinol, or THC. THC is the chemical responsible for marijuana's euphoric high. GW calls Epidiolex the first in a new category of anti-epileptic drugs.

But that means the DEA will have to reschedule Epidiolex from its current Schedule 1 status. These are drugs the DEA deems to have no medicinal use and a high potential for abuse. The rescheduling can occur within 90 days. GW can't sell Epidiolex before then.

"This suggests the launch is unlikely to occur until (the fourth quarter of 2018)," Janney analyst Ken Trbovich said in a report. "GW has indicated this is not a concern since it will hire and train its field sales organization during this time."

Trbovich notes Epidiolex could soon have competition from Zogenix. In September, Zogenix reported strong results from a Phase 3 study of its Dravet syndrome treatment. The drug reduced monthly convulsive seizures by 72% compared to 17% for those on the placebo, he wrote.

"While acknowledging there are no head-to-head studies and there are significant differences in patient populations between the Zogenix and GW Dravet studies, consider that Epidiolex showed a 39% reduction in seizures vs. 13% for placebo in its Phase 3 Dravet study," he said.

Trbovich has a sell rating on GW stock.

It probably tanked because it would be like if they found out that dandelions cured cancer and so they patented dandelions.. Anybody can grow dandelions in their backyard, why would they pay a huge company with a monopoly on the marketplace to make it for them?

 

[Brian4Liberty]

It probably tanked because it would be like if they found out that dandelions cured cancer and so they patented dandelions.. Anybody can grow dandelions in their backyard, why would they pay a huge company with a monopoly on the marketplace to make it for them?

That's what I was thinking. Can't you get something like this at any marijuana store? I guess the market would be in States where marijuana is still illegal.

 

[dannno]

That's what I was thinking. Can't you get something like this at any marijuana store? I guess the market would be in States where marijuana is still illegal.

You can order it now, from any state afaik... I know someone who just ordered some in a state where it is questionably legal at best.. it's made from hemp tho, so what are they going to do? Start arresting people with hemp necklaces too?

https://www.thecbdistillery.com/

 

[Rider420]

So this is still about medical marijuana not about stuff like catatonic. I don't see problems in it.

 

[TheTexan]

This is a great leap forward for medical science. Who would have thought that by simply packaging an otherwise illegal plant into pill form, that it could become medicinally useful?

 

[jkr]

This is a great leap forward for medical science. Who would have thought that by simply packaging an otherwise illegal plant into pill form, that it could become medicinally useful?

MERK