A first-of-its-kind study using human donors is examining the potential of CBD for treating chronic bladder pain. Cannabis Health speaks to the scientist leading the research.
Chronic pain is an oppressive human health problem that affects millions worldwide. In 2011 alone, the direct and indirect costs of chronic pain were at $600 billion dollars in the USA. This outweighs the costs related to heart disease, cancer, and diabetes combined.
Among these patients are the nearly eight million women and four million men suffering from interstitial cystitis (IC), commonly referred to as chronic bladder pain.
The symptoms of this chronic disease include pelvic pain and urinary storage dysfunctions, which can severely impact quality of life.
There are currently no adequate treatments for people with chronic bladder pain and scientists say new therapeutic approaches are desperately needed to not only prevent pain but also address co-morbidities such as social isolation, depression and anxiety.
A growing body of evidence suggests that cannabinoids could be the answer for treating chronic pain and inflammation. And as the research effort increases, the formulation of novel cannabinoid formulations progresses alongside it.
One of these formulations, developed by Desert Harvest Inc., packages cannabidiol with aloe vera to increase the bioavailability of CBD by 25 per cent.
As with most areas of CBD research, evidence regarding its efficacy is limited, however, a new collaborative study between Desert Harvest and the McGill University Research Centre for Cannabis in Montreal hopes to change this.
The two-phase study aims to validate whether the CBD and aloe vera formulation could alleviate the pain symptoms in a preclinical model of IC.
Dr. Reza Sharif-Naeini who leads the study said: “For the past 20 years or so, there hasn’t really been any development of new therapeutic drugs for patients with chronic pain.
“By partnering with industry colleagues, we’re trying to accelerate the speed to market for these analgesics so that the patients can benefit from them.”
The first phase of the study involved a rodent model in which mice were administered a compound that metabolises acrolein in the liver.
The compound then accumulated in the bladder causing tissue damage. The symptoms are similar to human IC, including bladder inflammation, pain and bladder overactivity.
Initial data from the study are encouraging. The researchers demonstrated treatment with the cannabidiol-aloe vera formulation significantly reduced pain symptoms.
“Although we only tested it for seven days, it was enough for us to see a significant reduction in bladder pain experienced by these animals,” Dr Sharif-Naeini said.
“It is a very important and exciting discovery.
“The next step for us is to start testing these compounds on human pain neurons to determine whether the effects can be translated to humans.”
The second phase of the study, expected to begin within the next month, will involve testing the effect of cannabidiol on neurons obtained from deceased human donors.
Dr Sharif-Naemi explained: “We’ve partnered with surgeons in local hospitals, so as soon as a donor dies the nervous tissue, including the pain-sensing neurons, can be harvested and kept alive in a small dish for about two weeks.
“[We] can assess the function of these pain neurons and see what happens when we apply these cannabinoid drugs to them.
“This way, we’ll be able to tell directly whether these compounds would have a beneficial effect on humans.”
The pain transmission pathway can be broken down into three steps. First are pain-sensing cells in the ‘periphery’, such as the skin or, in this case, the bladder. These nerve fibres detect the pain stimulus and transfer the information to the spinal cord.
At the spinal cord, pain transmitting neurons take information up the spine and into the brain where the third step takes place. This final step is referred to as pain interpretation.
“Cannabinoids can affect either one of these steps or all three of them together,” Dr Sharif-Naeini added.
“We think that in the periphery, cannabinoids prevent the activation of your pain-sensing neurons. This means that your nervous system doesn’t even detect the pain information; it is not allowed to enter into your central nervous system.
“This is what we’re going to test in the second phase of these studies.”
Sadly, current pharmacological treatments for chronic pain, mainly opioids, are burdened with severe side effects. A rise in opioid prescription over the past decade has led to what is referred to as the opioid epidemic.
Although not a primary factor, the treatment of chronic pain is thought to be linked to this crisis.
“The absence of proper pain management is one of the contributing factors that led us to the opioid epidemic in America, so there’s really a push to develop new treatments,” Dr Sharif Naeini said.
“There are people doing opioid research to come up with better ways of eliminating the side effects of opioids, but eventually we’re going to come to a place where maybe we have gotten all that we can out of opioids, and we need new alternatives.”
Dr Sharif-Naeini believes that cannabinoids could be a future alternative.
“Cannabinoids are an alternative with high potential. The more studies that are done, the more people can make informed decisions about what [medication] they take for their pain.
“Every time more research comes out it’s great because it allows us to better understand how the cannabinoid system functions.
“The hope is that we can develop better tools that will allow us to reduce pain in some of these intractable chronic pain syndromes, without necessarily affecting the patient’s functioning and cognitive capacity.”
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
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.
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.
Dr Anthony Ordman, Consultant in Pain Medicine
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.
Alex Fraser, Patient Access Lead at GrowPharma
Alex 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
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
Dr Sally Ghazaleh, Consultant Pain Specialist
Dr 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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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
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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