Medical

Historic milestone as first marijuana-derived medicine approved by FDA

Historic milestone as first ma...
The FDA has for the first time approved a medicine derived from a restricted component of marijuana
The FDA has for the first time approved a medicine derived from a restricted component of marijuana
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The FDA has for the first time approved a medicine derived from a restricted component of marijuana
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The FDA has for the first time approved a medicine derived from a restricted component of marijuana

In a landmark announcement the US Food and Drug Administration (FDA) has approved a new drug consisting of cannabidiol (CBD), to treat two rare forms of severe childhood-onset epilepsies. CBD is a cannabinoid derived from marijuana and the FDA's approval of this new medicine will force the US Drug Enforcement Administration (DEA) to reschedule the compound from its current restricted level.

CBD is one of over 100 different cannabinoids found in marijuana. Unlike its more psychoactive cousin, tetrahydrocannabinol (THC), CBD generally doesn't cause the commonly associated euphoric effects marijuana is known for. A rapidly growing body of evidence is finding a whole host of different beneficial medical uses for CBD, from controlling chronic pain to improved anxiety disorders. But the strongest research in CBD's favor has been its ability to reduce the frequency of uncontrollable seizures in epilepsy.

The newly approved CBD medicine, called Epidiolex, has been formulated to treat two severe forms of childhood-onset epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome. Both conditions are notoriously treatment-resistant and this final FDA approval comes after years of research and clinical trials working to establish the efficacy of this treatment.

"This approval is the culmination of GW's many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine," says Justin Gover, CEO or GW Pharmaceuticals, a company at the forefront of this drug development process.

"These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician's care."

One of the fascinating implications of this FDA approval is that it will force the DEA to redetermine its current restrictive scheduling of CBD. For decades marijuana, and all its chemical components, has been classified as a Schedule 1 drug. This is the most restrictive level of drug control the US federal government has. It means a drug has a high potential for abuse, no safe use and no accepted medical use. Other Schedule 1 drugs include heroin and LSD. Cocaine and methamphetamine are Schedule 2 drugs.

In 2016 the DEA went even further in restricting broader uses of marijuana-derived compounds, clarifying the Schedule 1 listing to include all "marijuana extracts" including any derived cannabinoid. While many US states have moved to legalize both medical and recreational cannabis products, federal law still stands in direct contrast, maintaining the Schedule 1 classification.

For Epidiolex to become a legally available drug that doctors can prescribe the DEA will have to reschedule CBD. It is estimated that this rescheduling determination will occur within 90 days from this new FDA announcement. It's unclear how the DEA will approach this rescheduling decision but it seems unlikely to shift marijuana, as a whole plant, down from its Schedule 1 classification. What is possibly more likely is that CBD will be specifically separated from marijuana as its own unique compound, and classified at a more accessible level.

Either way this is a milestone moment in the broader medical and legal acceptance of drugs derived from substances previously considered taboo and medically useless. The FDA's approval of CBD as a legal medicine will indirectly allow many off-label prescriptions for the compound but it could also have much larger repercussions.

One legal writer has gone so far as to hypothesize the approval of Epidiolex as starting a domino effect of marijuana acceptance, ultimately leading to the legalization of the plant in the United States. That may be an extreme outcome, but in the short-term this FDA approval is an encouraging moment of legitimization for a field of medical research that has long been pushed the fringes.

Source: FDA

6 comments
Brian M
It was never sensible, logical or rational to prohibit any drug for medical use (or research) if its efficacy can be shown. At the same time there is no good reason why cannabis or its derivatives should be allowed for recreational use. Hopefully the law will gain some sense, but not go as far as legalising cannabis, we have enough health problems with legal tobacco, smoking cannabis is even worse for our health.
Observer101
It's ABOUT TIME.... Marijuana, for medical use and research, SHOULD be legal. There may be many advantageous uses still to be uncovered. Back in the early 70's a Doctor I knew proposed the use of marijuana to treat glaucoma. He was laughed at and ridiculed, but years later I saw where many were "treating glaucoma" with marijuana. POINT IS, there are some legitimate uses, not the least of which is the treatment of PAIN associated with cancer patients, especially terminally ill patients. I am NOT in favor of legalizing marijuana for recreational use, (as I am not convinced that it doesn't harm the lungs - as well as other things), but I DO think it should be left to the STATES, and the people, NOT the Federal Government..... Just think of what the Government could do with the money and resources they currently spend on marijuana issues, (enforcement, apprehension, prosecutions, confinement,) if they leave the issues to the individual states....
Skyler Thomas
Oh Brian M. I would like to know why Cannabis in particular should not be used recreationally when it is less likely to be associated with domestic violence and auto accidents than alcohol, and does not have the same cardiovascular risks as regular tobacco use, just to mention a couple points. As for whether there is a good reason for recreational use, well why do we recreate if not for enjoyment? Now I don't like to use it regularly myself, but every once in a while I like to enjoy it recreationally. Seems like a good enough reason to me.
EZ
To Brian M.: You ought to try it. It's actually a healthy way to feel better without the side effects of prescription drugs. Part of the problem is the "forbidden fruit" concept. As it becomes more "acceptable" it will also become less "abused." Kind of like how prohibition made matters worse.
Daishi
There has been a domino effect of marijuana acceptance. Possession or use of marijuana without an accompanying crime should never be considered a valid reason to put otherwise law abiding people into the criminal justice system. If nothing else it's a waste of tax dollars to take tax payers and make them a tax burden. Legal marijuana brings in a lot of tax revenue. There are bigger problems to solve and more important things to spend public funds on than having police kick in people's doors and destroy families and lives over marijuana. I've never had an issue with someone because of marijuana but I have had the police kick in the door with loaded guns and arrest my dad for growing weed. I've seen police ruin a LOT of peoples lives in the name of protecting them from fairly harmless marijuana. Marijuana prohibition is basically a tax funded war on poor people. I'm no SJW but my family was pretty much collateral damage in a policy probably intended to oppress brown people. Backing marijuana prohibition would be like betting on a horse that's sure to lose at this point. I'd caution against it.
piperTom
The DEA should be required to demonstrate the efficacy of jail as a "treatment" for whatever they think is a "problem". An oath like physician's 'Do no harm' would put them totally out of business.