By Luke Sumpter


Epidiolex belongs to a group of products known as cannabis-based medicines. Whereas whole-plant extracts contain hundreds of different phytochemicals, cannabis-based medicines harness 1–2 molecules of interest. In the case of Epidiolex, manufacturers set their sights on the non-intoxicating cannabinoid CBD (cannabidiol).

Following a set of human trials, Epidiolex won Food and Drug Administration (FDA) approval in the United States for the treatment of severe forms of epilepsy. Find out everything you need to know about this formula, how it works, and how it compares to CBD oil.

What Is Epidiolex?

Epidiolex made history as the first FDA-approved prescription CBD product. The innovation stems from the UK-based company GW Pharmaceuticals, which also created Sativex—a balanced concoction of THC and CBD. Each bottle of Epidiolex contains 100ml of oral solution and a total CBD content of 10,000mg.

The FDA gave the green light for Epidiolex specifically to treat patients experiencing seizures associated with Lennox–Gastaut syndrome and Dravet syndrome. Because these neurological conditions also affect young children, the administration has indicated the use of the preparation for patients as young as two years old.[1] So far, over 15,000 people have received Epidiolex to combat these conditions.[2]

  • When Was Epidiolex Approved?

The FDA approved Epidiolex on June 25th, 2018. After decades of federal prohibition, this move signalled a huge shift in the perception of cannabis within the upper echelons of authority. Many cannabis purists argued, and still argue, that this move only served to benefit mega-corporations in their efforts to patent and profit from the plant.

Whether true or not, from the perspective of parents looking to reduce seizures in their children, federal approval of Epidiolex opened legal avenues to potential relief.

This decision followed a series of controlled clinical trials that showed significant seizure reduction in participants treated with the cannabis-based medicine. As more trials are conducted, other cannabinoid formulations may become approved and available in the future.

FDA Commissioner Scott Gottlieb, MD stated during an FDA news release: “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”.[3]

When Was Epidiolex Approved?

How Epidiolex Works

Epidiolex harnesses the power of CBD to target a variety of receptors involved in epilepsy. Many cannabinoids, including THC, exert their action through the endocannabinoid system (ECS)—a “universal regulator” of the human body. CBD, however, has a low binding affinity to the major receptors that make up this system. Instead, ongoing studies suggest it helps to balance out neurotransmitter firing through a number of other sites.

  • The Science Behind Seizures

Before we delve into how Epidiolex works at the cellular level to combat seizures, we need to make sense of how seizures arise in the first place. Under normal conditions, neurons in the brain exist in a state of balance. The electrochemical signals that flow through them are tightly controlled by the excitatory neurotransmitter glutamate and the inhibitory neurotransmitter GABA.

While at rest, neurons contain a bunch of positively charged potassium ions—the mineral we ingest every time we chew into a banana. However, a much greater number of positively charged sodium ions sit on the other side of the cell membrane, causing the inside of the neuron to maintain a negatively charged state.

Once an electric pulse (known to science as an action potential[4]) hits a particular neuron, it causes channels dotted along the membrane to open. Sodium rushes into the cell while potassium rushes out. This causes the neurons to flip from being negatively charged to positively charged, and carry the signal down its neck (the axon) toward its tip (the synapse).

Here, the charge causes the neuron to release brain chemicals into the gap between neurons, known as the synaptic cleft. These molecules float over the space and bind to the receptors on neighbouring cells. What happens next depends on the type of neurotransmitters released.

The Science Behind Seizures

Glutamate (the brain chemical that excites cells) binds to the receptors on nearby neurons and forces their ion channels to open. This causes them to also become positively charged and carry the electrical message onward. In contrast, GABA (the brain chemical that dampens activity) slams the brakes on this process. It instructs nearby neurons to close their ion channels and shut down the electrical signal.

Seizures occur when neurotransmitter levels become awry. During a seizure, groups of neurons in certain regions of the brain become “hypersynchronous” and excitable, and start sending out electrical discharges over and over again.[5] This occurs because of either too much excitation (glutamate release) or too little dampening (reduced GABA release).

Genetic factors that cause long-lasting glutamate receptor activation or give rise to dysfunctional GABA receptors underpin epilepsy. A surge in neuronal excitability manifests as obvious seizure symptoms such as shaking and losing consciousness, as well as symptoms subjective to the patient, including irregular smells and sensations of fear.

  • How Epidiolex Combats Seizures

So, where does Epidiolex come into the picture? This cannabis-based medicine affects numerous molecular targets implicated in seizures. Researchers are still getting to grips with exactly how CBD works at a cellular level to quell excess excitability. Some of the proposed mechanisms include:

TRPV1 As a proposed cannabinoid receptor, CBD binds to TRPV1. This site works to modulate seizures, and ramps up glutamate release and increases in calcium. Although this mechanism drives seizures, the receptor enters a state of desensitisation after activation by CBD.[6]
T-type calcium channels Calcium plays a major role in neurotransmitter release, and this receptor type causes an influx of calcium into the neuron when activated. CBD works to block these channels.
Serotonin receptors The role of serotonin receptors remains unclear when it comes to epilepsy. However, CBD binds to some of these sites, and researchers believe this could underpin the molecule’s mechanism of action.[7]
Opioid receptors Certain opioid receptors play a role in epilepsy, and CBD works to block them when present in high concentrations.[8]
GPR55 Some researchers have named GPR55 the third cannabinoid receptor. This site works to modulate synaptic transmission, and CBD directly binds to it.
  • Epidiolex Side Effects

While ongoing research looks promising, some patients experience side effects when taking Epidiolex. These include:

Drowsiness Decreased appetite
Fatigue Malaise
Rash Insomnia
Infections Drug interactions

What Is Epidiolex Used For?

Currently, the FDA has only approved the use of Epidiolex for seizures associated with two specific conditions. However, ongoing research continues to explore its efficacy in other maladies, including chronic pain and anxiety.

  • Epidiolex for Seizures

Epidiolex prescribing information published by the FDA strictly indicates its use in patients with two forms of epilepsy:

  • Lennox–Gastaut syndrome: A severe form of epilepsy that manifests in early childhood and often leads to cognitive dysfunction.
  • Dravet syndrome: A rare, drug-resistant form of epilepsy that shows symptoms in the first year of life.

The administration based the approval of Epidiolex on data collected from four key clinical trials consisting of a total of 550 participants with either Lennox–Gastuat or Dravet syndrome.[9] One of these studies, published in the journal Neurology, looked at the long-term safety and efficacy of Epidiolex as an add-on treatment for patients with Lennox–Gastaut syndrome. Despite 11% of the participants leaving the trial due to side effects, 88% reported an improvement in their condition and a reduction in seizure frequency.[10]

Another of the key studies, this time published in the journal Neuropediatrics, investigated the long-term safety and efficacy of Epidiolex in patients with Dravet syndrome. A total of 264 patients participated in the study, and the researchers noted a reduction in seizure frequency and improvements in patient condition over a period of 48 weeks.[11]

What Is Epidiolex Used For?
  • Epidiolex for Chronic Pain

Ongoing studies are exploring the role of Epidiolex in the management of chronic pain. The ability of CBD to bind to serotonin receptors as well as transient receptor potential cation channels (TRP) receptors enables the cannabinoid to act on pathways involved in pain signalling and the inflammatory process.[12] However, a series of high-quality clinical trials are needed before agencies will consider approving Epidiolex for this purpose.

  • Epidiolex for Anxiety

Scores of anecdotal accounts describe CBD’s potential to ease the mind and soothe the body. A handful of human trials have also explored CBD as a treatment option for anxiety. Imaging studies have investigated how the cannabinoid alters blood flow in key brain regions,[13] and trials even tested the molecule in a simulated public speaking event.[14] CBD shows potential in this area, but more trials are needed to push agencies such as the FDA to approve Epidiolex for this use.

Is Epidiolex the Same As CBD Oil?

Although they share the same key ingredient, Epidiolex and CBD oil are not the same. For starters, each 100ml bottle of Epidiolex contains a highly standardised formula consisting of 10,000mg of CBD and inactive ingredients including dehydrated alcohol, sesame seed oil, strawberry flavouring, and sucralose—this never changes.

In contrast, CBD oils are available in a massive range of formulas. You’ll find different ingredients, flavours, and concentrations. CBD oils also contain more cannabis phytochemicals than Epidiolex, such as aromatic terpenes and additional non-psychotropic cannabinoids, like CBG and CBN, that work in synergy to create an entourage effect.[15]

Despite its lack of phytochemical diversity, the strict pharmaceutical manufacturing process used to create Epidiolex means patients receive exactly what they’re expecting every time. This standardisation leads to the accurate dosing and strict quality control required of products to earn FDA approval. For now, the FDA has limited Epidiolex for a short list of conditions. However, as research continues, it seems likely that this cannabis-based medicine will help to tame the symptoms of more conditions in the future.

External Resources:
  1. EPIDIOLEX® (cannabidiol) oral solution https://www.accessdata.fda.gov
  2. FDA Approved Drug | EPIDIOLEX® (cannabidiol) https://www.epidiolex.com
  3. FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana to Treat Rare, Severe Forms of Epilepsy | FDA https://www.fda.gov
  4. The action potential in mammalian central neurons | Nature Reviews Neuroscience https://www.nature.com
  5. Synchronization and desynchronization in epilepsy: controversies and hypotheses - PubMed https://pubmed.ncbi.nlm.nih.gov
  6. TRPV1 Channel: A Potential Drug Target for Treating Epilepsy https://www.ncbi.nlm.nih.gov
  7. Use of Cannabidiol in the Treatment of Epilepsy: Efficacy and Security in Clinical Trials https://www.ncbi.nlm.nih.gov
  8. Delta opioid receptors in brain function and diseases https://www.ncbi.nlm.nih.gov
  9. Drug Trials Snapshots: Epidiolex | FDA https://www.fda.gov
  10. Long-term Safety and Efficacy of Add-on Cannabidiol (CBD) Treatment in Patients with Lennox Gastaut Syndrome in an Open-label Extension Trial (GWPCARE5) (P5.5-001) | Neurology https://n.neurology.org
  11. Long-term cannabidiol treatment in patients with Dravet syndrome: An open-label extension trial - PubMed https://pubmed.ncbi.nlm.nih.gov
  12. An Update of Current Cannabis-Based Pharmaceuticals in Pain Medicine - PubMed https://pubmed.ncbi.nlm.nih.gov
  13. P.3.006 Effects of cannabidiol (CBD) on regional cerebral blood flow | Request PDF https://www.researchgate.net
  14. Cannabidiol reduces the anxiety induced by simulated public speaking in treatment-naïve social phobia patients - PubMed https://pubmed.ncbi.nlm.nih.gov
  15. Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects - PubMed https://pubmed.ncbi.nlm.nih.gov
Disclaimer:
This content is for educational purposes only. The information provided is derived from research gathered from external sources.

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Privacy Policy - Royal Queen Seeds

To ensure a safe online environment and guarantee adequate data protection, we strictly comply with all legal requirements. In this privacy statement, we provide information about how and for what purpose data is collected, safety measures, storage periods and contact details.


COMPANY NAME: SNORKEL SPAIN, SL (hereinafter ROYAL QUEEN SEEDS)

C/ Vilar d'Abdelà, 5 (nave 1) CP: 08170 de Montornès del Vallès

+34 937 379 846

support@royalqueenseeds.com


The present Privacy Policy sets out the terms on which we will treat personal data at ROYAL QUEEN SEEDS; this includes any personal data collected through our website https://www.royalqueenseeds.com/ as well as any other data we process in the course of our business activities.

ROYAL QUEEN SEEDS collects the following personal data for the purposes listed below:

SECTION 1 – PERSONAL INFORMATION WE COLLECT

1.1 Account purchases

Account purchases can only be made if you are in possession of a personal account. When you create an account or purchase something from our shop, as part of the buying and selling process we collect the following personal information that you provide to us:

This information is required for delivery. In addition, when you browse our shop, we automatically receive the Internet Protocol (IP) address of your computer. Based on this information, we can optimise your online experience and at the same time protect our online environment.

Purpose of data collection

We collect and store account-related data for the following purposes:

(a) to carry out obligations arising from any contracts between you and us, and to provide you with information, products and services that you may request from us;

(b) to set up, manage and communicate with you about your account and your orders;

(c) to conduct market research and analysis;

(d) to confirm your age and identity, and to detect and prevent fraud.

1.2 Newsletters

With your explicit permission, we may send you newsletters about our shop, new products and other updates. We send newsletters based on your explicit consent. In the event that you purchase a product, and in accordance with current regulations, we may send you commercial communications in accordance with the legitimate interest of our company, always about products or services similar to those you have purchased or contracted. In any case, you may exercise your right of opposition through the channels announced in this Privacy Policy. The following information is collected in relation to the newsletter:

We do not need to know the sex of the person in order to send the newsletter (data minimisation: by law we must ask for data that is strictly necessary to provide the service, and in this case knowing the sex is not necessary to send the newsletter).

Purpose of data collection

The data collected is used to:

(a) personalise our emails, including your name and gender;

(b) provide gender-specific content.

You can withdraw your consent at any time by using the link provided in the newsletter or the contact information provided in section 2.

1.3 Customer service and contact form

In order to provide appropriate support, our customer service employees have access to information related to the account. Consequently, their support will be highly effective and friendly. The data provided in our contact form is used by our CRM provider, SuperOffice. We will only use your details to respond to your message.

SECTION 2 – LEGITIMATE INTEREST

If you have purchased any of our products, please note that we may process your personal data for promotional purposes, based on Royal Queen Seeds' legitimate interest only to offer you products or services from our company and about products or services similar to those you have purchased. You may exercise your right to opt out of future messages by the means set out in this Privacy Policy or through any notification you receive.

2.1 How do you withdraw consent?

If you change your mind, you can withdraw your consent for us to contact you for the purpose of collecting, using, or disclosing your data at any time by reaching out to us at: support@royalqueenseeds.com.

SECTION 3 – DISCLOSURE

We may disclose your personal information if we are required to do so by law or if you breach our Terms of Service.

SECTION 4 – HOW LONG DO WE KEEP YOUR DATA?

At Royal Queen Seeds, we will not retain your data for longer than is necessary for the purposes described in this Policy. Different retention periods apply for different types of data; however, the longest period we will normally hold any personal data is 10 years.

4.1 Account information

Data relating to the account remains relevant for as long as the consumer is in possession of an account. Therefore, the data remains documented for as long as the account exists. When our customers delete an account, the associated data will be deleted within a reasonable period of time. Requests regarding the inspection or correction of stored personal data or the deletion of an account can be sent to support@royalqueenseeds.com.

4.2 Newsletters

In the event that you give us your consent to inform you about our products or services, we will keep your data until you express your wish not to receive any further communications from us. However, we regularly (every month) carry out a relevance check. Registered customers (and their personal information) will be deleted whenever customers do not reply to our request. In addition, our newsletter mailing has an opt-out feature. Consumers can withdraw their consent by using this opt-out feature.

SECTION 5 – COOKIES

Cookies are small information files that notify your computer of previous interactions with our website. These cookies are stored on your hard drive, not on our website. Essentially, when you use our website, your computer displays its cookies to us, informing our site that you have visited before. This allows our website to function more quickly and remember aspects related to your previous visits (such as your username), making your experience more convenient. At Royal Queen Seeds, we use two types of cookies: functional and analytical.

5.1 Functional Cookies

Functional cookies are used to enhance your online experience. Among other things, these cookies track what is added to your shopping cart. The use of these cookies does not require prior authorization.

5.2 Analytical Cookies

Analytical cookies are used for research and market analysis. The data collected with these analytical cookies is anonymous, making it unusable for third parties. The use of these cookies does not require prior authorization.

SECTION 5 – THIRD-PARTY SERVICES

Third-party services are required to conduct transactions and provide our services. In general, the third-party providers we use will only collect, use and disclose your information to the extent necessary to enable them to perform the services they provide to us.

However, certain third-party service providers, such as payment gateways and other payment transaction processors, have their own privacy policies regarding the information we must provide to them for your transactions.

We encourage you to read the privacy policies of these providers so that you can understand how these providers will handle your personal information.

In particular, certain suppliers may be located or have facilities located in a different jurisdiction than yours or ours. Therefore, if you choose to proceed with a transaction involving the services of a third party, your information may be subject to the laws of the jurisdiction in which that service provider or its facilities are located.

Once you leave our website or are redirected to a third-party website or application, you are no longer governed by this Privacy Policy or the Terms of Service of our website.

Web analytics service (anonymous data)

On this website we have integrated an element of a web analytics service (with anonymisation functionality). Web analytics can be defined as the gathering, processing and analysis of data about the behaviour of visitors to websites. An analytics service collects, among other things, data about which website a person came from (the so-called referrer), which sub-pages they visited or how often and for how long they visited a sub-page. Web analytics is mainly used for website optimisation and for a cost–benefit analysis of internet advertising.

Courier service

To complete deliveries we use a courier service. This courier service carries out the delivery between our company and the consumer's home. To complete these logistics, the company requires access to the consumer's name and address information.

Mailing service

Royal Queen Seeds uses a third-party mail service provider to send its newsletter. This provider has access to limited account information related to opt-in consent (e.g. email address).

Marketing services

Royal Queen Seeds has the support of a company that specialises in marketing and communication activities. Their access to personal information is very limited and mostly anonymous.

Payment services

At Royal Queen Seeds we use external payment services to handle our transactions (e.g. credit card payments).

SECTION 6 – SECURITY

To protect your personal information, we take reasonable precautions and follow industry standard best practices to ensure that it is not inappropriately lost, misused, accessed, disclosed, altered or destroyed.

If you provide us with your credit card information, the information is encrypted using secure socket layer technology (SSL) and stored using AES-256 encryption. Although no method of transmission over the internet or electronic storage is 100% secure, we follow all PCI-DSS requirements and implement additional industry standards that are commonly accepted. Information related to the account is protected with a hashing method. This method transforms the information into a generated hash. As a result, confidential information is protected and invisible, even to us. In addition, our databases are exceptionally protected against unauthorised access. For example, access to the database is only possible and permitted via approved IP addresses (e.g. from Royal Queen Seeds headquarters). Other attempts and addresses are rejected at all times.

Furthermore, data is anonymised as much as possible, so it cannot be directly linked to a specific consumer. With this data, however, we may be able to carry out market research and analysis. In addition, the third parties concerned (e.g. mailing service) are examined prior to our collaboration, comply with the GDPR from the EU and receive a processing agreement. Within Royal Queen Seeds, employees are assigned different access permissions. Specific permission provides access only to information that is strictly required to perform a task. Digital security measures are subject to change and must meet high requirements to ensure the safety of online customers. That is why, at Royal Queen Seeds, we appoint a security officer. Regular verification and improvement of security measures (where necessary) are part of the role.

SECTION 7 – CHANGES TO THIS PRIVACY POLICY

We reserve the right to modify this Privacy Policy at any time, so please check back regularly. Changes and clarifications will be effective immediately upon being published on the Website. If we make substantial changes to this policy, we will notify you here that it has been updated so you will know what information we collect, how we use it and under what circumstances, if any, we use and/or disclose it.

SECTION 8 – YOU HAVE THE RIGHT TO: