A new UK trial will explore the effects of medical cannabis in patients with fibromyalgia and chronic pain.
Primary research sites will be located in the US and the UK, with the hopes of fast-tracking traditional FDA and NHS timelines by running phase trials in parallel.
A human pilot study will be launched in coordination with an internationally recognised clinical research group based at the University of Manchester.
In addition, parallel molecular and pharmacokinetic studies will be conducted in the US with key scientists and colleagues of Dr Annabelle Manalo-Morgan, Flora’s lead scientific advisor.
“A paradigm shift is upon us where healthcare practitioners, researchers, patients, and adult-use consumers are starting to understand, accept, and embrace the therapeutic potential offered by phytocannabinoid-based medicine,” said Dr Manalo-Morgan.
“As such, there is an urgent need for more research to better understand the molecular and biochemical effects of cannabis at the cellular level, to begin to apply its implications as a pharmaceutical drug.”
According to an announcement earlier this month, Flora intends to work with government regulators, as well as academic institutions to initiate academic studies in order to reduce costs and develop new cannabis-based drugs.
It plans to “honour the traditional FDA and NHS route in scientific processes” to deliver cannabinoids for specific disease conditions, backed by data, with an initial focus on fibromyalgia, brain health, pain, and related research.
The firm’s immediate next steps are to submit data for ethics committee review, with further details expected upon approval.
Dr Manalo-Morgan added: “I’m extremely pleased that our team recognises the importance and necessity of this research, not only to create and bring to market novel pharmaceutical cannabis products for patients around the world that are more efficacious and have a superior safety profile compared to traditional and incumbent pharmaceutical treatment options, but to also enhance long-term shareholder value.”
Medical cannabis reduces pain and opioid use in cancer patients – study
Findings suggest that medicinal cannabis can be carefully considered as an alternative to the pain relief medicines.
Medical cannabis reduces cancer-related pain and the need for opiate-based painkillers, reveals a new study in oncology patients.
A comprehensive assessment of the benefits of medical cannabis for cancer-related pain, has found that for most oncology patients, pain measures improved significantly, other cancer-related symptoms also decreased, the consumption of painkillers was reduced, and the side effects were minimal.
Published in Frontiers in Pain Research, these findings suggest that medicinal cannabis can be carefully considered as an alternative to the pain relief medicines that are usually prescribed to cancer patients.
Pain, along with depression, anxiety, and insomnia, are some of the most fundamental causes of oncology patient’s disability and suffering while undergoing treatment therapies, and may even lead to worsened prognosis.
Author, David Meiri, assistant professor at the Technion Israel Institute of Technology, explained: “Traditionally, cancer-related pain is mainly treated by opioid analgesics, but most oncologists perceive opioid treatment as hazardous, so alternative therapies are required.
“Our study is the first to assess the possible benefits of medical cannabis for cancer-related pain in oncology patients; gathering information from the start of treatment, and with repeated follow-ups for an extended period of time, to get a thorough analysis of its effectiveness.”
Need for alternative treatment
After talking to several cancer patients, who were looking for alternative options for pain and symptom relief, the researchers were keen to thoroughly test the potential benefits of medicinal cannabis.
“We encountered numerous cancer patients who asked us whether medical cannabis treatment can benefit their health,” said co-author Gil Bar-Sela, associate professor at the Ha’Emek Medical Center Afula.
“Our initial review of existing research revealed that actually not much was known regarding its effectiveness, particularly for the treatment of cancer-related pain, and of what was known, most findings were inconclusive.”
The researchers recruited certified oncologists who were able to issue a medical cannabis license to their cancer patients. These oncologists referred interested patients to the study and reported on their disease characteristics.
Bar-Sela said: “Patients completed anonymous questionnaires before starting treatment, and again at several time points during the following six months. We gathered data on a number of factors, including pain measures, analgesics consumption, cancer symptom burden, sexual problems, and side effects.”
An analysis of the data revealed that many of the outcome measures improved, with less pain and cancer symptoms. Importantly, the use of opioid and other pain analgesics decreased.
In fact, almost half of the patients studied stopped all analgesic medications following six months of medicinal cannabis treatment.
“Medical cannabis has been suggested as a possible remedy for appetite loss, however, most patients in this study still lost weight. As a substantial portion were diagnosed with progressive cancer, a weight decline is expected with disease progression,” reported Meiri.
He continued: “Interestingly, we found that sexual function improved for most men but worsened for most women.”
Meiri would like future studies to dig deeper and look at the effectiveness of medicinal cannabis in different groups of cancer patients.
“Although our study was very comprehensive and presented additional perspectives on medical cannabis, the sex, age, and ethnicity, as well as cancer types and the stage of the cancer meant the variety of patients in our study was wide-ranging. Therefore, future studies should investigate the level of effectiveness of medicinal cannabis in specific subgroups of cancer patients with more shared characteristics.”
Lack of research preventing wider prescribing of cannabis for arthritis
The review found limited progress in understanding the potential of cannabis for the treatment of pain.
A lack of research is preventing wider uptake of medical cannabis prescribing for arthritis pain, according to a new review published in the US.
A new review article has found that there has been limited progress in understanding the potential of cannabis-based therapies for the treatment of pain associated with rheumatic conditions in the past five years.
The article concluded that this is primarily due to a lack of standardisation of clinical research and barriers to conducting research due to existing federal and state regulations in the US.
The review, which was published by CreakyJoints, an international digital community for arthritis patients and caregivers, found that the legalisation and decriminalisation of cannabis at a state level in the US reflects changing attitudes about cannabis as use of the drug increases across a broad range of conditions, including rheumatic diseases.
Unfortunately, while there is strong preclinical evidence showing that cannabis-based products play a role in alleviating pain and reducing inflammation, the highly variable state and federal statutes have limited patient-centred prospective research, education of clinicians and comfort of patients in disclosing their cannabis use to clinicians.
W. Benjamin Nowell, PhD, director of patient-Centered research at CreakyJoints said: “In 2019, CreakyJoints presented data from our ArthritisPower Research Registry study showing more than half of arthritis patients reported wanting information on or actually had tried cannabis and/or cannabidiol products for a purpose they perceived as medical – often for pain relief and help sleeping.
“Yet, three years later, there’s been virtually no advancement in the research necessary to provide clinical evidence that rheumatologists and patients need to make decisions about cannabis use for symptom relief in combination with approved treatments.”
He added: “Without this research, it is impossible to develop clinical guidelines for medicinal cannabis in the US, which is vital for patients seeking the full range of treatment options to explore in partnership with their physicians. The best way to treat rheumatic conditions is through the use of US Food and Drug Administration approved medications, which are backed by evidence demonstrating their effectiveness and safety profile.”
Only three cannabis-based medications are approved by the US Food and Drug Administration, none of which are for the treatment of pain or other symptoms related to rheumatic conditions.
Lack of research stymying uptake of medical cannabis
Researchers draw attention to an array of studies that have shown that cannabinoids are effective in the laboratory at decreasing inflammation in cells and reducing inflammation and pain in mice and rats.
In addition, studies in humans that support efficacy are primarily surveys of people using medicinal marijuana who report relief of pain. However, in rheumatic diseases, there are very few studies of cannabis-based therapies in humans and the clinical trials conducted to date have small sample sizes and inconsistent methods.
“Although the clinical evidence about cannabis for rheumatic disease pain is lacking, it is nevertheless important to educate patients about the known benefits and risks of alternative treatments, including medical cannabis,” said Dr Stuart Silverman, rheumatologist, clinical professor of medicine, Cedars-Sinai Medical Center and UCLA School of Medicine and medical director, OMC Clinical Research Center.
“As a rheumatologist who treats patients with pain, I am aware that some of my patients have found cannabis to be an effective option when traditional medications fail to reduce their pain.
“I am open to discussing medical cannabis when patients express an interest in its use. Then, if they choose to use it, I follow them closely to monitor efficacy and any side effects and to ensure that they do not consider it as a replacement for FDA-approved disease-modifying drugs.”
CreakyJoints recommends that rheumatologists and healthcare providers be prepared to “discuss medicinal cannabis with their patients in an empathetic, non-biased manner”.
Study shows safety of using cannabis with opioids
Findings suggest that CBD and THC are safe for use with opioid pain medication.
Researchers in the US have found that using cannabis with opioids does not increase the risk of addiction.
Findings from a new study suggest that CBD and THC might be safe for use with opioid pain medication, without increasing the risk of addiction.
Although more studies are needed, the results suggest that these compounds, found in cannabis, might be a low-risk way to reduce the dose of opioids needed to relieve pain.
The results show that CBD and THC do not enhance the rewarding effects of opioids, meaning that these compounds may not increase the risk for addiction when used in conjunction with opioid medications.
In the new study, the researchers gave rhesus monkeys the opportunity to choose a food reward or an injection of the opioid fentanyl.
They then tested whether CBD, THC or mixtures containing both compounds affected the number of times monkeys selected fentanyl over food.
They found that a wide range of doses of CBD or THC both alone or in a mixture did not increase or decrease the number of times they selected fentanyl.
Medical cannabis is often cited as an alternative pain reliever to opioid medication, with many patients finding they are able to reduce the number of opioids they are taking after being prescribed cannabis.
Lawrence Carey, PhD, a postdoctoral fellow at the University of Texas Health Science Center, San Antonio, said: “There is intense interest in using medical marijuana in patients with chronic pain because compounds in marijuana like CBD and THC may produce pain relief themselves or enhance the pain-relieving effects of opioids.
“This means people could potentially use lower doses of opioids and still get relief from pain. Taking less pain medication could also lead to a lowered risk of addiction or physical dependence to opioids.”
He continued: “Giving the animals the opportunity to choose between a drug injection and a food reward helped us to somewhat replicate choices a human drug user may face, such as whether to spend money on drugs or food.
“Having the option of responding for food is also useful for studying drugs like THC that produce sedative effects. It helps demonstrate the animal is reallocating behaviour from drug to food choice instead of simply shutting down response for a drug due to sedation.”
The researchers are now conducting other studies to assess whether CBD and THC can decrease signs of opioid withdrawal and relapse.
“A big reason why people continue to take opioids after they become addicted is the appearance of withdrawal symptoms,” said Carey.
“We are using what we learned from this study to determine whether these doses — which didn’t alter choice for food or drug rewards — may help relieve opioid withdrawal or decrease relapse and drug seeking behavior following periods of abstinence.”
The researchers caution that opioid use disorder is a complex disease and there are many factors to consider when developing a drug to treat it.
Although this study indicates that THC and CBD do not increase the rewarding effects of opioids, they say that before applying these findings to people, it will be necessary to determine whether these treatments alter other pathological processes involved with opioid use and to better understand any risks that may be associated with their use.
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