A new refractory epilepsy treatment, containing THC, has been approved for import into the UK for the first time.
A new cannabis treatment for refractory (or drug-resistant) epilepsy, containing THC, has been approved by the Medicine and Healthcare products Regulatory Agency (MHRA) for import into the UK.
This is the first time that the UK authorities have approved for import an epilepsy treatment containing THC, which is on a clinical pathway (Phase IIB).
CannEpil+ which is produced by European based MGC Pharmaceuticals, will initially be used to treat 10 patients in the UK who suffer from the condition.
MGC Pharma will be providing CannEpil+ free of charge to these patients on compassionate grounds for six months.
Now officially approved for import into the UK, a doctor can issue a prescription for CannEpil+ for both adults and children.
The approval to import CannEpil+ into the UK is in response to the urgent need of some patients to have access to a clinical product which has demonstrated its efficacy at treating refractory epilepsy, as well as its safety.
Once the first 10 patients have commenced their treatment, CannEpil+ will undergo an observational trial with data being entered into a data collection app designed to establish a central platform to monitor the safety of treatment in patients globally.
Refractory epilepsy affects approximately 33 percent of adults and 20-25 percent of children suffering from epilepsy. In the UK, around 87 people are diagnosed with epilepsy in the UK every day.
MGC Pharma’s biosimilar effect-identical product, CannEpil has historical clinical safety and efficacy data.
It is expected that this, combined with the results from the observational study, and a further clinical trial that is currently under negotiation with a UK NHS facility, will provide specialist neurologists and general practitioners with the confidence to prescribe CannEpil and CannEpil+ to patients in urgent need of treatment.
Further Phase IIb randomised, double blind, placebo-controlled clinical studies on the drug are expected to begin in the final part of 2021, following negotiations.
This will take place at the Schneider Hospital in Israel and within the NHS in the UK. It will focus on the safety and efficacy of CannEpil+ as a supplementary treatment in children and adolescents with refractory epilepsy.
“This is a huge step forward for cannabis-based medications in the UK,” commented Robin Emerson, COO of Elite Growth Ltd and high-profile medical cannabis advocate.
“As a father of a five-year-old girl I have witnessed first-hand how Jorja’s life has been transformed by the use of a Cannabis based medication that contains THC.
“With this product approval, patients that have tried everything else now have a product with some level of safety and efficacy for the treatment of epilepsy that can be prescribed by their physician.
“With the ongoing clinical trial portfolio that MGC Pharma have developed, including a near term UK NHS based trial, we are answering the call of clinicians in the UK who are asking for safety and efficacy data. The CannEpil+ programme we are executing will go a long way to moving cannabis-based medications toward greater adoption and acceptance, opening up much needed access for patients in the UK.”
Matt Hughes, co-founder of charity Medcan Support, whose son Charlie is prescribed medical cannabis for refractory epilepsy, told Cannabis Health: “This is great and welcomed news, we hope this helps families involved and builds on the current evidence base which already shows the use of THC is well tolerated, effective and safe under clinical guidance.”
CBD guides: Could CBD help with women’s intimate healthcare?
The endocannabinoid system can play a huge role in helping women’s health issues.
As the number of intimate care CBD products on the market continues to increase, we examine how CBD could help.
CBD has been associated with women’s health issues such as period pain relief, menopause insomnia and even hormonal acne. But as CBD is also thought to help us achieve homeostasis (balance) in the body, could it help to maintain vaginal health?
Women’s health and the endocannabinoid system
The endocannabinoid system is thought to regulate different functions in the body such as sleep, mood, appetite, memory and fertility. It is made up of receptors, enzymes and endocannabinoid that are found naturally all over the body. There are two major receptors called CB1 and CB2.
CB1 is usually found in the central nervous system, while CB2 is found in the peripheral nervous system. Endocannabinoids bind to the receptors to help with different problems such as pain.
The vagina, bladder and urinary tract also have endocannabinoid receptors.
CBD, unlike THC, does not bind the receptors. CBD may supplement the endocannabinoid system helping to regulate your system. The cannabinoids travel the receptor that has been stimulated and needs extra help to achieve a balance.
Depending on the dose and which receptor it is, CBD is thought to help anxiety, sleep problems, inflammation and pain.
This could be especially useful for those struggling with conditions such as endometriosis, painful periods or anxiety around sex.
When it comes to vaginal health and women’s health concerns in general, how could CBD help?
CBD may help with painful periods due to its anti-inflammatory properties. During a period, the uterus contracts to shed its lining while releasing hormone-like substances called prostaglandins. These substances are involved in inflammation and pain while triggering muscle contractions. Higher levels of prostaglandins may mean more painful menstrual cramps.
One study from 2019 revealed that women with endometriosis self-rated cannabis or CBD as most effective for soothing pain. This was compared with other practises such as yoga and stretching.
Another study, which was focused on arthritis in rats, found that CBD gel applied to the area may help to reduce pain and inflammation.
Endometriosis is an extremely painful condition that can be debilitating. The tissue from the uterus can become attach itself to other organs in the body such as fallopian tubes, ovaries or pelvis.
Studies have shown that women are increasingly turning to CBD for help alleviating the pain of endometriosis. There are on-going studies into how exactly CBD suppositories or tampons may help endometriosis but there are no results as of yet.
A study into fibromyalgia and pelvic pain for women from 2021 revealed that over one-third of the women surveyed were current CBD users with 81 per cent of this group stating the use had ‘improved their pain.’ A further 76 per cent of users said they were able to substitute CBD for other medications including opioids, NSAIDS, gabapentinoids and benzodiazapams.
There are many different reasons for vaginal dryness including menopause, medication and even particular times of a menstrual cycle.
CBD may help to soothe any redness or irritation caused by vaginal dryness. If the skin is more sensitive as a result the anti-inflammatory properties may reduce any swelling or issues of eczema or dermatitis.
CBD is thought to be potentially anti-fungal which may help with yeast infections.
However, its important to note, before you grab your CBD oil, that there are no direct studies for yeast infection. CBD may be able to boost the effects of caryophyllene oxide or beta-caryophyllene. Both of these are terpenes that are found in the cannabis plant. An older study from 1999 highlighted caryophyllene as a potential help for fungal infections in nails and the skin.
CBD may also offer some relief for irritated or itchy skin as a result of fungal infections such as candida. This is due to its potential anti-inflammatory properties which can help to reduce redness or swelling.
What is the best CBD to use internally?
While it may be tempting to use our existing CBD products in our intimate areas, it’s best not to.
CBD products for intimate areas are formulated to be used internally which means they are safe. Oils or topicals may contain ingredients or perfumes that can cause infections. The vagina contains a type of bacteria, a Lactobacillus. It produces lactic acid and helps to lower the pH of the vagina, but any form of imbalance can result in infections or thrush.
How to use CBD internally
The most common ways to use CBD vaginally are lubricants and suppositories.
While suppositories may seem scary, they can be one of the easiest ways to take CBD. They are made from from oils such as coconut, that can melt at body temperature. The CBD can take a few minutes to be absorbed by the body once it has melted the oil. It is worth noting that it can be a bit messy when the oil melts, so using something like a sanitary pad can place a barrier between your clothing and the oil.
Sex and women’s health
Latex and safety
Another way that oil-based products may cause a problem, is with latex. Oil can erode latex condoms or glide dams causing them to break or split. If CBD products are being used during sex, always make sure that the CBD being used is water-soluble.
Some people can feel really anxious around sex, due to past experiences, pain or being intimate with a new partner.
A lot of the studies conducted on anxiety and sexual anxiety appear to be focused on men. However, more general anxiety and CBD studies do have a more mixed-gender ratio.
A review from 2020 suggested that CBD could help with anxiety disorders. In reducing anxiety, a person’s libido may increase helping them to feel like sex more.
When the vagina is aroused, the mucous membranes in the vulva and vagina begin to produce a natural lubricant. This is also referred to as vasodilation, the natural process of our bodies expanding our blood vessels to allow more oxygen into certain tissues.
Some studies show that CBD may help with this process by increasing sensitivity and blood flow around the body. CBD is absorbed through the mucous membranes in the vagina and straight into the blood vessels. It is one of the quickest ways to absorb a dose of CBD as it doesn’t have to pass through the digestive system.
CBD suppositories and lubricants are designed to be used internally.
How CBG has been a game changer for my ADHD
Stephan shares how CBG has helped him manage his symptoms of ADHD
Stephan Ryan shares how he has found cannabis, particularly CBG, helpful in managing symptoms of ADHD.
The number of people being diagnosed with ADHD has risen during the last two years of the pandemic, with three-quarters of newly diagnosed adults saying that the fallout from lockdown had encouraged them to seek an evaluation. Some of the reasons for this were listed as working from home, where there were more external factors for distraction, as well as the rise in ADHD-related social media channels.
Stephen Ryan, who is originally from Germany but now lives in Ireland, said: “Last year during Covid, I had a period where I was completely unable to focus. My partner at the time suggested I may have ADHD, and the symptoms completely fit, a lot of my behaviour started to make sense.
“I start a lot of projects that I never finish and go down a million rabbit holes. Work can present barriers that feel so insurmountable that I can’t focus or I can’t work on it for days before getting in trouble for not having done the work.”
Some of the other symptoms Stephen noticed were restless leg syndrome, which is associated with the dopamine deficit experienced by those with ADHD and periods of hyper focus. But as the pandemic progressed, he noticed that he was finding it increasingly difficult to focus.
Stephen has seen his GP and is now waiting on an official diagnosis of ADHD from a specialist. Covid has meant a long delays to services which has left a lot of patients in Ireland going private. Unfortunately, this can mean several hundred Euros to see a doctor before paying for any potential prescription.
Stephen has been told to expect at least three to six months waiting time or around €700 for an assessment. The cost of private diagnosis and prescriptions can be hugely daunting for patients.
Attention Deficit Hyperactivity Disorder (ADHD) is a neurological condition. It can affect people’s behaviour in that they can seem restless, they may have trouble concentrating and seem impulsive. While a lot of people are diagnosed at a young age, increasing numbers of adults are being diagnosed with the disorder.
ADHD can often be missed in childhood, especially for women, which has led to a rise in adult diagnosis. It can also present differently which makes it even more difficult to diagnose.
ADHD is often divided into three different types:
Inattentive: An individual may struggle to organise or complete tasks, pay attention to details, follow instructions or conversations. It also causes a person to be easily distracted or to forget parts of their daily routine.
Hyperactive: A person with hyperactivity may fidget or move or talk a lot. They can struggle with sitting still for a long period of time due to feeling restless. They also struggle with impulsivity and may interrupt frequently, speak at inappropriate times or fail to wait for their turn. They may be more accident-prone.
Combination: They present symptoms of both hyperactivity and inattentiveness.
ADHD and CBG
Stephen began consuming cannabis before he realised it may help his ADHD symptoms. While he saw some success with THC or CBD, he believes that cannabigerol (CBG) was more helpful for him.
CBG is another cannabinoid found in the cannabis plant alongside THC and CBD. It is sometimes referred to as ‘the mother of all cannabinoids’ because it is the precursor to CBD and other cannabinoids.
There is very little CBG in plants, often as low as one per cent, making it more expensive than CBD products, as CBD is much more available. CBG tends to be made from younger plants, which contain a higher percentage. THC and CBD both begin life as CBGA before maturing.
It is thought to work the same as CBD in that it interacts with our endocannabinoid system via receptors that are found all over the body. In particular, it may bind to the CB1 receptors in our nervous system or CB2 receptors in our immune system. In recent studies, CBG has been shown to have the potential for preventing Covid-19 infections from entering the body and shows promise as an ingredient for skincare aimed at helping dry skin conditions.
There are no direct studies on CBG for ADHD, although there are some which focus on CBD and CBN.
“I was emotionally drained and completely without energy, cannabis helped me to get the rest I needed,” Stephen said.
“I found a store that sold CBD so I tried that before trying THC but it wasn’t beneficial for me. I didn’t feel an effect until I started using CBG.”
He continued: “It was an instant change in the way my body and mind reacted to the cannabis. I started to mix CBD in there too. I no longer felt exhausted or tired, instead I found I was motivated, always excited and got lots of work done.”
Stephen began to join Irish cannabis activism, which is calling for reform to the medical cannabis access programme (MCAP) and for the legalisation of recreational use.
Currently, ADHD is not a condition which can be legally prescribed for under the MCAP programme. While in Northern Ireland and the UK, this is not the case and patients can apply for a prescription, Southern Irish patients who live in these regions, cannot take their prescription into Ireland without risking arrest or seizure at customs.
This situation has resulted in a lot of Irish patients emigrating to countries such as the UK or Spain.
The MCAP was introduced in 2019, but can only be accessed for three conditions: cancer nausea, multiple sclerosis and epilepsy.
CBG and stress
Unfortunately, during the first lockdown, Stephen experienced a break-up with his partner who he lived with at the time.
“It was incredibly stressful but for the first time with the cannabis and CBG, I was able to get some self-reflection during this chaotic time of my life. CBG has been an absolute game-changer for me. I felt this incredible motivation, positivity and creativity,” he said.
“One thing I noticed with my cannabis use before I knew about my ADHD , is that after a tolerance break, it had an amazing ability to put me in the zone.”
Stephen is conscious of the cannabinoids that he uses and how they make him feel, preferring to use a CBD flower, after finding that THC and CBD did not suit him. He is open to the idea of a prescription for medical cannabis but feels that it may be a while before ADHD is recognised by the MCAP.
“I would be happy to go on the system if it was available for me, I would be proud to have a prescription because it is a medicine and this is the first step of not being criminalised for it,” he said.
Stephen hopes that general awareness of ADHD Ireland will improve to help those who may need more support, especially in schools. He would also like to see less of a gap between the recreational and medicinal communities.
“I would love to see more awareness,” he said.
“When I was in school, the classes were too big for teachers to pay any attention to individual students, so there wasn’t much understanding of it.”
Stephen added: “Cannabis is medicine. The term recreational has been mixed up in that sense, as it means to recreate yourself mentally, physically and spiritually, but it’s become a negative storyline. People are getting the health benefits by consuming it. We need to change the narrative around this, that’s why we are becoming activists.”
How this US brand is helping veterans access free CBD
“U.S. military veterans are some of the most selfless individuals so we thought the project would be a perfect fit.”
US vaping supply brand, CCELL, has partnered with the Veteran’s Walk and Talk project to provide free access to CBD.
CCELL will be partnering with the Veterans Walk and Talk (VWAT) to gift its members with limited edition CBD vapes that highlight their military service.
Veterans Walk and Talk is a community project based in the US, offering support, psychedelic therapy and cannabis.
It was founded in 2016 by Colin Wells, who served in the US Army, as a way for veterans in Southern California, Sacramento and Oklahoma, to take control of their health journey.
The project now holds regular community outreach events that provide veterans with a one-on-one psychedelic or cannabis walk and talk therapy or group hikes. They also hold trail and beach clean-ups where the community come together to give back to nature along with book clubs and comedy nights.
To mark the firm’s fifth anniversary, the CCELL team decided to join forces with VWAT.
Speaking with Cannabis Health, Joe Strain, vice president of CCELL said: “VWAT started with veterans in mind. Founder Colin Wells, who served in the US Army and experienced withdrawal traumas, began posting on social media to see if anybody wanted to join him on his hikes as a means to relieve stress.
“On these hikes, he’d provide free cannabis, education and a safe space for people to talk. These hikes inspired him to start VWAT as a way to give back to his community, with the main goal of reducing the suicide epidemic among veterans. Now, VWAT has 12 chapters across the country, all carrying the same mission.”
Joe added: “US military veterans are some of the most selfless individuals, so we thought they would be a perfect fit. We heard about what VWAT is doing for veterans and decided to support the organisation on its mission to help improve the lives and health of veterans by providing them with CBD vaporisers. The alignment was undeniable, and we’re honoured to be a part of helping them further their mission.”
Mental health and veterans
Mental health conditions such as anxiety, depression and post-traumatic stress disorder (PTSD) can be common among veterans. The symptoms of PTSD can be debilitating causing flashbacks, nightmares or physical effects such as nausea or pain.
A study from 2017 highlighted the difference in PTSD between veterans and civilians. In the study of 5,826 veterans, researchers recorded a rate of 13 per cent with PTSD. This is almost double the seven per cent of the US population with a PTSD diagnosis.
Studies show CBD may help PTSD by interacting with the endocannabinoid receptors in the body.
Joe explained: “It’s known that many veterans deal with PTSD after they have served. Studies have shown that CBD can be effective in reducing PTSD symptoms. This can potentially afford members the opportunity to manage their symptoms without excessive pharmaceutical drugs, which often cause side effects.”
He added: “CCELL has produced limited edition CBD vapes which will signify that the users of the vapes are members of Veteran’s Walk and Talk. Not only is this great for the members, but it is also significant for this non-profit organisation as it helps to spread awareness about the great work that VWAT does and will help encourage more people in need to join.”
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