EU has approved medicinal cannabis for the first time as a potential treatment for the patients suffering from two rare and severe forms of childhood epilepsy.  Doctors have been recommended the Epidiolex, plant-derived cannabis-based oral suspension as a long term treatment option for the children with Dravet syndrome or Lennox-Gastaut syndrome. But not all the parents are satisfied with it and want an alternative consisting of a component not included in this drug.

CBD or cannabidiol is a chemical component of Cannabis sativa plant, commonly known as marijuana. CBD doesn’t cause euphoria or high in the consumers. Basically, it is the THC that is the main psychoactive component of Cannabis.

Epidiolex is 100% free of this psychoactive component, tetrahydrocannabinol or THC. Due to this, parents don’t find this drug as useful as with THC and come up with the observation that this treatment is not effective for the children because it doesn’t contain THC which is actually helpful in reducing the frequency of seizures in epilepsy.

The medication introduced by GW Pharmaceutical as a treatment for epilepsy would be used in combination with clobazam which is another epilepsy medication.

Is this medicinal cannabis approved worldwide or not?

The US Food and Drug Administration FDA approved the Epidiolex last year for the first time as the treatment for Dravet syndrome. It is a rare genetic disease with frequent fever-related seizures.

In a statement, FDA Commissioner Scott Gottlieb said, “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development.”

On the other hand, CHMP- the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Humans Use also has a positive opinion about the recommendation of this product.

The CHMP’s positive opinion depends on the results from 4 trials including 714 members suffering from either Dravet Syndrome or Lennox- Gastaut syndrome. The results demonstrated that the frequency of seizures can be effectively reduced with cannabidiol products instead of placebo.

The oral solution is also approved in the UK for use; however, NHS doesn’t recommend its use currently. A month ago, due to the absence of evidence of its long haul viability, the UK’s National Institute for Health and Care Excellence settled on an initiative decision about not recommending the prescription of Epidiolex.

Legal Medicinal Cannabis Products Containing THC

Many other cannabis products containing THC are legalized in the UK in 2018. But these medicines can only be prescribed by the specialist doctors only in the case if other medicines have failed to do the job.

Nabilone is a cannabis-based medicine, legal in the UK. It is available in the form of capsules and works in a similar way to tetrahydrocannabinol or THC. This drug may help people with nausea in the case of chemotherapy.

Sativex is also a drug derived from cannabis plant consisting of both THC and CBD. This drug is also legal in the UK to help people with multiple sclerosis.

Related- Use of cannabis oil to treat epilepsy is expensive, NIH says

Epidiolex is not a Magical Bullet

Extensive trials and clinical studies are carried out to prove the efficacy of this cannabis-derived drug. A Professor of Neurology at UCL and Medical Director at Epilepsy Society, Ley Sander said:

“This is good news for children with some of the most serious forms of epilepsy. Epidyolex has been clinically trialed to prove its efficacy and safety so, where appropriate, physicians will be able to prescribe it in the knowledge that there is evidence to support its use.”

“Epidyolex has been through extensive clinical trials and although not a magic bullet, we know that it may work for some children whose seizures do not respond to current treatment options. But like all anti-seizure drugs, it would seem that Epidyolex may work for some children but not for others.”

In short, this positive step made by the EU for the approval of Epidiolex as a treatment for epilepsy will bring hope among the people suffering from deadly disease. However, restorative cannabis, in any case, will remain a question mark and there are many obstacles ahead to approve its marketing authorization.

Reports suggest that there is an increasing trend of using CBD-based products in the United States of America. According to a recent report from Acosta, “The CBD Effect: A Rapidly Emerging Consumer Trend”, almost a quarter of the United States of America customers are using cannabidiol (CBD) products.

Among 28% of consumers, 19% of them are using CBD-based products depending upon their need and 9% of them daily. Acosta also predicts revenue of $20 billion through CBD-based products by 2024. 

The consumption of CBD products is getting popular across the globe because of its health benefits. It is one of the constituents of the hemp plant along with tetrahydrocannabinol (THC).

Colin Stewart, vice president at Acosta, says that the increasing sales of CBD-based products depict the consumer’s trust in it. As individuals from all age groups try to avoid chemicals when it comes to their health, CBD products provide a perfect alternative to cure certain diseases. 

 In comparison, customers usually think positive regarding CBD-infused products. According to an interesting study from Acosta, 55% of the users are of the say “CBD oil is a miracle medication”, while only 11% of them consider these products just a hype. 

Top barriers and Farm Bill

Some top barriers of consumer’s mistrust on CBD products are limited research (29%), moral issues (18%), cite pricing (7%), limited regulation (7%) and lack of faith in the product’s claim (29%). The users mostly consume these products to diminish joint pain, relieve anxiety and general wellness. 

After the ratification of Farm Bill in the USA last year, the central administration had changed the categorization of cannabis. It eliminated industrial hemp from the classification of marijuana in the Controlled Substances Act of the United States.

Hence, the production of hemp is legal in the United States of America now. On the other hand, marijuana is still a Schedule I drug on the list of FDA. 

Under the United States Food and Drug Administration (FDA), both THC and CBD cannot be mixed with food. Also, they can’t be sold under the category of dietary supplements. The FDA regulates products including cosmetics, food, and drugs that have THC or CBD as an additive. 

The retailers have shown a great interest in CBD products as well

The popularity and the potential of CBD-infused products have attracted a great deal of both small and large scale retailers including Kroger CO., which is the substantial supermarket operator of the country. Other small scale retailers including Dierbergs Markets and online retailers like Thrive Market have also shown a great interest in CBD products. 

Till now, CBD products are available in more than 1,300 stores of the Kroger across 22 states of the USA. It includes Fred Meyer, King Soopers, Pick ‘n Save, and QFC. Kroger also has balms, oils, and creams of CBD in its stores of the Houston division. Additionally, it also provides customers with the facility to shop online. 

According to Stewart, the sales of CBD-infused products would be larger than the current sales of gum, mints, and candy combined annually by 2024. The research also indicates that one in 10 owners of the pet purchase CBD-infused items for their pets. 

In the market, only a handful of companies are now integrating innovative technologies to extract medical cannabis. These technologies come up with high efficiency for operations at a smaller level that cannot develop the infrastructure themselves.

Medical cannabis extraction is of paramount importance in the whole process of medical cannabis production. The process can be challenging as engineers haven’t designed an equipment specifically for the cannabis extraction yet. Consequently, the yield is not at its optimum level.

Challenges for innovation in cannabis extraction

GMP (Good Manufacture Practices) certification is a standard to approve any industrial equipment and procedure. Currently, companies concerning the extraction have a tough time getting the GMP certification.

Some companies had applied for the certification for over a year but got no approval. However, different methods to extract medical cannabis are available which will not get certification of GMP. Therefore, it is vital as a company to invest in the tools and devices that would be beneficial for the company.

The GMP will consider those techniques and equipment fit for approval that integrate latest tech and depict specification.

Future of medical cannabis production

Medical cannabis products will be the deciding factor in the evolution of the extraction process. Carbon dioxide extraction method is among the popular methods to extract medical cannabis nowadays. It is because the extraction process does not need any bomb proof amenities and is the method with no by-products.

Some companies are beginning to explore extraction methods of ethanol and hydrocarbon through butane and propane. Although these methods would need a bomb proof material, the opportunity is considerable.

US and Canada realize that it can be challenging for organizations to develop a convenient infrastructure for extraction. Therefore, private medical cannabis extraction companies are advantageous for the emerging industry.

Europe, however, is deficient in creating innovative products. Mostly the products are dried cannabis or capsules. There is fundamentally no development in topical lotions, sublingual and transdermal products. It is something Europe will have to consider and learn from North America to get good share in the global market.

What does the cannabis production market demand?

Medical cannabis will have the lion’s share in the contribution of cannabis market growth. The United States of America has had a fair deal of dedicated researchers and the engineers for the matter. Canada is already joining hands with the US in the cause.

Anyhow, there are also high hopes from Europe in the market. With the population of 700 million people, global medical cannabis market alone can make till around 200 billion USD.

After a decade or two, the shape of the global cannabis market will change entirely. Europe will also play a huge role in it along with North America and Israel.

However, research profiles are considerably low, and they need to speed up to better support the positive forecasts. The future of the market seems to be positive with the advent of more interest growing in the industry. However, there is a dire need to integrate latest technologies that are solely specified for cannabis extraction.