This week something historical happened in medicine and pharmaceuticals. The FDA put their stamp of approval and legalized a CBD-based epilepsy medication. We can consider this as a win for the hemp-supporting community, as this is the first-ever FDA approval of a marijuana-based drug that is substantiated with firm evidence.
It’s a monumental movement in the right direction as far as CBD goes in competing with traditional medicine. I’m super excited and those at GW Pharmaceuticals are excited as well.
FDA Approved GW Pharma Product To Treat Epilepsy
The official approval happened on Monday, the 26th of June 2018, with the drug Epidiolex. This is made from purified Cannabidiol – CBD oil. The producer of the drug Epidiolex is GW Pharmaceuticals. Cannabidiol is a natural ingredient of cannabis, but unlike THC, CBD does not get you high and does not have any kind of psychotropic influence. Instead, the CBD is believed to have great benefits to the health and well-being of the body and mind.
Epidiolex is the new hope for people suffering from epilepsy. No doubt about that!
This Epidiolex has been just approved by the FDA. The drug Epidiolex is intended for treating two forms of epilepsy – the Dravet syndrome and Lennox-Gastaut syndrome. This drug is intended for persons over the age of two and has been shown to drastically reduce seizures. The bright side of this drug is that it does not induce some of the unwanted side effects, unlike the typical medication used before that may have resulted in nausea, vision problems, and liver damage.
Where Does The FDA Stand?
The official FDA press release stated that this should not be considered as a “sweeping legalization” of marijuana. The release further stated that this is a significant medical advance and a decision that has been brought forth after a number of significant clinical trials that have proven the effectiveness of the drug. And the CBD oil used in this drug is in a very purified state that is formulated to be delivered in a reliable and effective concentration to ensure beneficial results.
Guess what, millions of people are already using CBD oil as a food supplement.
We have been witnesses of the ever-growing community of CBD oil users and supporters of the entire hemp culture that continually state that CBD oil is beneficial in pain relief, as a sleep aid and even as a depression relief agent.
But before the drug hits the marketplace, it will have to be cleared by the DEA, as CBD oil is currently classified as Schedule I drug – a drug with no medicinal value. Even though CBD oil rated as a food supplement is legal across the USA, the official distribution of Epidiolex will have to wait on a green light from the DEA.
It is still unclear how the drug will be sold or if it will be covered by medical insurance. There were some headlines referring to a Texas marijuana dispensary that treated a 2-year old boy with epilepsy, but unfortunately, the drug is not covered by insurance and a single 7.5 ml (0.2 oz) bottle costs about $105.
There Is Good News – Future CBD-based Medical Trials
The good news is that this is a pioneering step that will open many doors, especially for including medical marijuana and CBD oil in drug developing programs and medical trials. There are currently several programs that are working on including marijuana in the development of new drugs and in the revision of some existing drugs that are used for treating severe conditions. I’d like to add that lots of veterans use CBD to treat conditions – read about that here.
Even though the FDA will not succumb under pressure, they will continue to implement strict rules and rigorous conditions when developing and regulating new drugs using medical marijuana.
The Future – We’ll Soon Find Out
We should be happy that a progress has been made, and if we really want to see a change, then we should support science and support the research and incorporation of marijuana as a potential treatment for many health-related conditions.
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