Epidiolex is a new drug approved by the FDA in June to treat seizures associated with two rare and severe forms of epilepsy. Cannabidiol (CBD) is its main ingredient. This non-psychoactive substance can also be found in cannabis plants. It is the agency's first approved product containing a marijuana-derived drug substance.
The DEA has declassified it, which means that federal restrictions on controlled substances have been lifted from it. This is a significant step, as it will make it easier for physicians to prescribe this breakthrough medicine to patients.
The DEA's action marks the final step of the regulatory process. This means Epidiolex will no longer be controlled, and it can be prescribed by all states without any state prescription drug monitoring.
This is a major milestone in the development this novel therapy to treat patients with Dravet syndrome and Lennox Gastaut syndrome. These are the two most difficult forms epilepsy forms to treat. These conditions are characterised in the development of seizures very young and with a dearth of treatment options.
GW Pharmaceuticals, Inc. has been granted FDA approval to start marketing Epidiolex to treat seizures in patients over the age of two. It has had a great success rate in clinical trials and is currently being used by approximately 15,000 people worldwide.
About the product
The FDA evaluated four large clinical trials of Epidiolex, and concluded that it is effective in treating symptoms of these conditions. The FDA also approved the drug as an orphan drug, which is designed to help treat rare diseases and disorders that aren't found anywhere else.
It is a viscous fluid that can be used in syringes and dropspers. This is important, as THC can have psychotic effects and be toxic when taken in high quantities.
Regular use of this medication can greatly reduce seizures and associated seizure behaviors. Follow your doctor's instructions to take this medication. These are often small doses that can easily be increased if necessary.
Talk to your doctor before you start taking this medication. Side effects may include lethargy and sleepiness. It can also cause diarrhea and liver issues. These side effects can be serious so you should immediately stop using the drug.
Also, keep track of any changes to your health and speak with your doctor if necessary. This will enable your doctor to adjust your dose if necessary. It will help keep your condition under control, and allow you to get back to normal.
After one month of taking this medication, you can expect to notice a significant improvement in your symptoms. Some patients notice that the severity of their seizures is reduced significantly, and many report feeling a sense of peace.
FAQ
Can I use CBD during pregnancy?
There hasn't been enough research to determine if CBD can be used during pregnancy.
However, the little information available suggests that CBD is unlikely to cause harm to the baby.
It's important to note that CBD should not be taken by pregnant women unless recommended by their doctor.
In fact, the Food and Drug Administration recently issued a warning about potential risks associated with taking CBD while pregnant.
FDA claims that "there are some evidences that cannabis consumption during pregnancy may increase the likelihood of miscarriage."
The agency added that more research is needed before a firm conclusion can be drawn.
What does CBD's price vary in different states?
Prices for CBD products will vary depending on where they are located. Prices can vary by as much as ten times depending on where you live.
The prices go up the further you go north. CBD in Alaska costs $35 per gram. In Hawaii, however, it costs about $200 per gram.
This trend continues throughout the country. Prices range from $5 up to over $2,500 for a gram.
Why is this happening to you?
Price variations are due to the different levels of regulation. Some states require that CBD products have very low levels of THC (the psychoactive part of marijuana). Other states don’t care about how much THC is in CBD products.
Some companies sell products in one state, and then ship them to another.
What are the best uses for CBD?
CBD can be used as an alternative to anxiety treatment. It can also be used for pain relief, epilepsy treatment, inflammation, depression and other conditions.
There are many ways you can consume CBD. You can eat foods containing CBD, drink CBD tinctures, vape CBD e-liquids, apply CBD creams and salves, or even put CBD drops under your tongue.
CBD can provide many benefits. It has been shown to help people suffering from chronic pain, PTSD, anxiety, and more.
What's the future for the CBD industry?
The future of CBD is bright. It's easy to see why so many people are jumping on board with this sector. With CBD products accounting for over $1Billion in global consumer spending, it is easy to see how the market is growing exponentially.
Statista reports that in 2019, global sales of CBD (cannabidiol) are expected to exceed $22.4 Billion. That's almost 200% more than in 2018!
It is also expected that the CBD market will grow at a compound annual growth of 22.5%. That would translate to approximately $6.8 million in revenue by 2020.
This is great news not only for existing businesses but also for companies looking to get into the sector. But, it is important to remember that the CBD industry is still in its infancy. There will be many challenges.
Statistics
- OralWhere HED is the human equivalent dose, and Km is a correction factor estimated by dividing the average body mass (BM) of the species (60, 0.020, and 0.150 kg for 11 humans, mice, and rats, respectively) and by its surface area (see: Nair et al. (ncbi.nlm.nih.gov)
- While the primary injury may not be treatable, interventions that attenuate secondary sequelae are likely to be of benefit [203].Only one study (ncbi.nlm.nih.gov)
- A recent study [161] also found that in vitro CBD treatment (i.e., ≤ 2 h exposure to 10 μM) induced ~40% vasorelaxation in isolated (pre-constricted) (ncbi.nlm.nih.gov)
- The use of these products is likely to become even more widespread if the World Health Organization's recommendation that CBD no longer is scheduled in the international drug control conventions is adopted by the United Nations member states [201]. (ncbi.nlm.nih.gov)
- As a substance that was federally illegal before the passage of the 2018 Farm Bill, hemp-derived cannabinoids with no more than 0.3% THC still face a regulatory grey area. (forbes.com)
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What are the issues that the CBD industry faces?
The market for CBD is growing at an astonishing rate. However, this market is still full of challenges for businesses that want to expand. These include lack of consumer awareness and high costs of entry, limited capital access, and regulatory uncertainty.
Many people are not aware of what CBD is, or how it functions. They are unable to make an informed decision about buying CBD products.
CBD companies are heavily dependent on word-of–mouth marketing. This is expensive because it requires paying for advertising and hiring staff to promote their brand.
Another issue for new entrants is the high cost production. CBD products require a lot of raw materials. CBD oil can only be made if hemp is grown in the right climate and soil conditions.
To grow enough hemp for CBD oil production, it costs approximately $1,000 per acre. Many small farmers are unable or unwilling to invest in this product.
The lack of capital access is another obstacle new entrants to the CBD market face. Due to the stigma surrounding the industry, banks discourage many people who wish to start businesses.
Last but not least, there is regulatory uncertainty regarding the sale and distribution of CBD products. There are no established guidelines regarding the marketing of CBD products.
Despite some states having passed laws restricting the sale CBD products, this is not yet a national policy.
So far, only two states - Maine and Nevada - have legalized recreational marijuana.
Massachusetts and Michigan, however, are exploring similar options.
These changes could lead to increased competition between CBD manufacturers.
Many entrepreneurs prefer to work at home over starting a business.