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Refractory epilepsy treatment containing THC approved for UK patients

This is the first time that the UK authorities have approved an an epilepsy treatment containing THC

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THC treatment for refractory epilepsy
A doctor can issue a prescription for CannEpil+ for both adults and children for the first time

A new refractory epilepsy treatment, containing THC, has been approved for use in 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 prescription for patients in the UK. 

This is the first time that the UK authorities have approved an an epilepsy treatment that is on a clinical pathway (Phase IIB) containing THC. 

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 to begin in the final part of 2021. 

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.”

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Beauty & Skincare

95% of patients with rare skin condition report improvements with cannabis topicals

Epidermolysis Bullosa causes severe blistering which can become infected after any trauma or friction.

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Skin condition: A white cream with a green cannabis leaf on top. It is surrounded by dark oil bottles and a spoon that has cream on it. This is on a dark background

A new study of a rare skin condition has revealed that different preparations of cannabinoids could have benefits for patients with painful Epidermolysis Bullosa (EB).

Epidermolysis Bullosa (EB) is the name of a group of rare inherited skin disorders that can cause the skin to become fragile.

It is thought to be caused by a gene mutation that makes the skin more fragile and any trauma or friction can cause painful blisters on the skin. There is currently no cure but treatment aims to prevent infection and reduce symptoms.

The study from the Netherlands and the United States analysed EB patients on five different continents who reported using cannabis preparations as a treatment for their rare skin condition.

The data is published in the Orphanet Journal of Rare Diseases. The patients reported using topical cannabinoid products in addition to inhaling cannabis flowers. They also consumed cannabis-infused edibles.

Patients were given a survey on their skin condition that focused on monitoring effects including perceived EB symptom changes, medication use, and side effects. 

Skin condition results

Results recorded that 95 percent said the topicals improved their overall skin condition symptoms with 94 percent stating their pain levels were decreased.

A further 91 percent said they had less itching and 81 reported wound healing was improved. Most of the participants at 79 percent said they had decreased their medication for their skin condition. The only side effect with a notable significance was dry mouth at 44 percent.

The authors noted that cannabis improved patient’s “perception of pain, pruritus, wound-healing, and well-being … and reduced concomitant medication use.”

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They wrote that: “Future prospective controlled clinical studies are warranted to elucidate the potential role of CBMs (cannabis-based medicines) in EB treatment.”

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Women's health

Canadian study shows more women using cannabis for menopause symptoms

Researchers analysed responses from 1,500 women living across Alberta

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Richardson: An app with menopause information displayed across the screen has a doctor's stethoscope resting on it.

A new study shows a large percentage of women have tried cannabis to manage their menopause symptoms.

The menopause study aimed to examine the rates and patterns of cannabis use and its perceived effectiveness in managing symptoms.

Researchers analysed responses from 1,500 women living across Alberta of which, 18 percent were in premenopausal, 33 percent were in peri-menopause and 35 percent were in post-menopause. There was also a small percentage that had either undergone a hysterectomy and or bilateral oophorectomy.

The NHS estimates that most people who experience menopause is between 45 and 55 years of age. This occurs when a person’s oestrogen levels decline. The average age for this to happen is 51. Around 1 in every 100 women enter into menopause early before 40 years old. This is referred to as premature menopause.

Common symptoms include hot flushes, night sweats, low mood, anxiety, vaginal dryness, difficulty sleeping and reduced sex drive. The average length of time that women can experience menopause is up to four years.

Menopause study results

A study from the University of Alberta in Edmonton Canada shows that one in every three women near the menopause transition uses cannabis for symptom management.

Of the women studied, roughly 33 percent reported using cannabis within the past 30 days. Out of the 499 current cannabis users, 75 percent stated they used it for medical purposes. This included the most common reason, sleep issues at 65 percent, anxiety at 45 percent and joint pain or aches at 33 percent. A further 29 percent reported they use cannabis for irritability and 25 percent for depression. Three-quarters of the current users reported that they found cannabis helpful with their symptoms.

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The most common way to take cannabis was edibles with 52 percent then oils with 47 percent. Just under half of those surveyed said they got their information from internet searches while 34 percent got their information from friends.

Researchers noted that women using cannabis were more likely than non-users to report sleep issues, mood issues including depression, mood swings, irritability and anxiety along with difficulty concentrating or painful intercourse.

Katherine Babyn from the University of Alberta and the first author of the study abstract said: “Our study confirmed that a large percentage of midlife women are using cannabis for symptoms that overlap with menopause, especially those women who reported more symptoms. In addition, many of these women are claiming to get relief for their symptoms through the use of cannabis.”

Dr Stephanie Faubion, NAMS medical director said: “While we continue to learn that more women are using cannabis to help manage their menopause symptoms, further research is required to assess the safety and efficacy of cannabis for menopause symptoms management.”

The results will be presented as part of The North American Menopause Society (NAMS) annual meeting in Washington DC next week. The study was funded by an operating grant from the Canadian Institutes of Health Research (CIHR).

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Industry

Royal Society of Medicine and Integro Clinics announce pain and cannabis medicines event

The event takes place on October 11 from 8:30 to 17:30. It will explore the potential of cannabis medicines in the field of pain medicine in the UK

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Event: The Royal Society of Medicine logo in green and red on a white background

The Royal Society of Medicine has announced a collaborative event, Pain and cannabis medicines: Everything you want to know (but were too afraid to ask) in association with Integro Medical Clinics.

The event takes place on October 11 from 8:30 to 17:30. It will explore the potential of cannabis medicines in the field of pain medicine in the UK

Since the legalisation of cannabis medicines on prescription in November 2018, patients and clinicians alike have been awaiting more data or information regarding these medicines. 

The event aims to provide those attending with a comprehensive understanding of the uses of cannabis medicines and the practicalities of using them in their own practice. It will consist of presentations on the history, regulatory environment and pharmacology of cannabis medicines including the use of different cannabis-based medical preparations in treating pain and related symptoms in a wide variety of clinical fields in the context of the current UK regulatory framework. 

Event presentations

The day will feature presentations from international leaders in cannabis medicines such as Professor Raphael Mechoulam, the chemist who discovered the endocannabinoid system and THC, Dr Anthony Ordman, Leading UK Consultant in Pain Medicine and previous President of the Pain Medicine Section of the Royal Society of Medicine and Dr Arno Hazekamp PhD, who worked as Head of Research and Education at Bedrocan, the first European company to produce EU GMP grade cannabis medicines.  

If you wish to sign up, please click here.

Event speakers
Dr Anthony Ordman, Consultant in Pain Medicine

Event: A black and white headshot of Dr Anthony Ordman Founder of the highly respected Chronic Pain Clinic at London’s Royal Free Hospital, he is one of the UK’s most experienced specialists in the treatment of pain. For his contributions to Pain Medicine, Dr Ordman was awarded a Fellowship of the Royal College of Physicians in 2005, and he is the Immediate Past President of the Pain Medicine Section of the Royal Society of Medicine. Dr Ordman is also Senior Medical Consultant and Lead Clinician at Integro Medical Clinics and has a special interest in the potential benefits of cannabis medicines in pain medicine.

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Alex Fraser, Patient Access Lead at GrowPharma

Event: A black and white headshot of guest speaker Alex FraserAlex Fraser is a leading medical cannabis patient advocate. He is a patient himself having been diagnosed with Crohn’s Disease in 2010 at 19 years old. In 2014 he founded the United Patients Alliance and has since appeared on mainstream media multiple times, including on the BBC and ITV, to highlight the urgent need for access to cannabis medicines for the many patients who may benefit from them. He has taken delegations of patients to parliament to give testimony to politicians at the highest levels and organised educational events, rallies and protests calling for law change on medical cannabis. In February 2019 Alex joined Grow Pharma, one of the leading suppliers of cannabis medicines in the UK, as their patient access lead. He utilises his extensive knowledge of medical cannabis, his understanding of patient needs and his network in the industry to ensure patient voices are heard and represented. His work includes informing top-level policymakers, educating healthcare professionals and conceiving and running projects that increase general awareness and provide practical help for patients.

Professor Raphael Mechoulam, Professor of Medicinal Chemistry at the Hebrew University of Jerusalem in Israel

Event: A black and white headshot Most well-known for the total synthesis of delta-9 tetrahydrocannabinol (THC) and the discovery of the Endocannabinoid System. Since the inception of his research in the 60s, Professor Mechoulam has been nominated for over 25 academic awards, including the Heinrich Wieland Prize (2004), an Honorary doctorate from Complutense University (2006), the Israel Prize in Exact Sciences – chemistry (2000), the Israel Chemical Society Prize for excellence in research (2009) and EMET Prize in Exact Sciences – Chemistry (2012

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Dr Sally Ghazaleh, Consultant Pain Specialist

Event: A black and white headshot of a guest speakerDr Sally Ghazaleh, is a Pain Management Consultant at the Whittington Hospital, and the National Hospital of Neurology and Neurosurgery, London. She qualified from the University of Szeged Medical School, Hungary in 2000, and then completed her specialist training in the Anaesthesia and Intensive Care Medicine at Semmelweis University in 2007. She went on a fellowship at University College Hospital, London, to gain her higher degree in Pain Medicine

During her time at the pain management Centre at University College Hospital, she gained extensive experience in dealing with and managing patients with complex multiple pain problems. She is accomplished at a variety of interventional and non-interventional treatments for this specific patient group. Sally specializes in managing patients with lower back pain, neck pain, neuropathic pain, abdominal pain, cancer pain, complex regional pain syndrome, post-stroke pain and Fibromyalgia. She has a particular interest in bladder and abdominal pain in women, and women’s health in general.

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