The medical world has only just begun to tap into the potential of cannabinoid-based medicines, including cannabidiol (CBD).
CBD is widely being used for mild pain relief and as a general wellness product, but the potential medical utility could go much deeper. At least one CBD product has already been approved by the US Food and Drug Administration (FDA) to treat certain forms of epilepsy in children, and pre-clinical studies of CBD have shown a positive impact in reducing inflammation. Inflammation in the form of redness or swelling of tissue is the body’s natural reaction to injury or infection and can typically be easily treated. However, serious complications can occur when uncontrolled inflammation disrupts vital organ function. Researchers and drug developers are now looking at CBD as a possible answer to a serious and potentially life-threatening form of inflammation, acute myocarditis. A clinical trial is being planned that could result in CBD gaining orphan drug status for the treatment of this condition.
Acute myocarditis: A potential use case for CBD
Acute myocarditis is a disease that results in inflammation of the heart muscle. Inflamed hearts can become weakened and enlarged, creating scar tissue that disrupts heart function and forces the heart to work harder to pump blood and oxygen throughout the body, which in turn can cause further inflammation. Acute myocarditis is one of the leading causes of heart failure in young people from puberty through their early 30s, and it is the leading cause of sudden death in children and young adults. Symptoms may include heart palpitations, chest pain, shortness of breath and swelling in the lower extremities. Serious complications include heart failure and even sudden cardiac death. Myocarditis is usually caused by viral infections but can also be caused by a number of bacterial agents or certain drugs, especially drugs used in the treatment of cancer.
This INNspired Article is brought to you by:Cardiol Therapeutics Inc. (TSX:CRDL; OTCQX:CRTPF) is focused on producing pharmaceutical cannabidiol (CBD) products and developing innovative therapies for heart disease, including acute myocarditis and other causes of heart failure.Send me an Investor Kit
Once acute myocarditis is diagnosed, there are few treatment options available. In mild cases, the inflammation may subside spontaneously over a few days and may even go undiagnosed. In cases where there is evidence of cardiac dysfunction, it is common to prescribe medications normally used to treat heart failure. In severe cases, there is often a need for intravenous medications, implantable devices to support cardiac function or even heart transplantation. Corticosteroids have been used but there has been no uniformly accepted evidence of benefit, and long term use can produce serious side effects. This lack of satisfactory treatment options has fueled interest and research into alternative means for treating acute myocarditis.
CBD and cannabis-based treatments for myocarditis
Cannabis legalization has allowed researchers to finally take a serious look at the medical applications of cannabinoids like CBD. There’s a long way to go to bridge the knowledge gap caused by prohibition, but the anti-inflammatory properties of CBD are becoming well-recognized. One study in the European Journal of Pain showed in an animal model that CBD could reduce inflammation caused by arthritis. Other studies have helped to demonstrate the mechanism through which CBD inhibits inflammatory pain.
A growing body of pre-clinical research suggests that there are anti-inflammatory and cardioprotective properties of cannabidiol in models of cardiovascular disease. One 2016 study published in the medical journal Molecular Medicine used an animal model to test the effects of CBD on T cell-mediated inflammation, cardiomyocyte cell death, fibrosis and myocardial dysfunction. The study demonstrated that CBD inhibited T cell-mediated myocardial inflammation and improved myocardial dysfunction.
“Collectively, our study demonstrates that CBD treatment markedly attenuates autoimmune myocarditis and improves myocardial dysfunction and heart failure primarily by its anti-inflammatory and anti-fibrotic effects,” the study concludes. “These results, coupled with the proven safety of CBD in human clinical trials and its current orphan drug approval by the FDA for different neurological seizure disorders, suggest that it has tremendous therapeutic potential in the therapy of acute myocarditis with different etiologies and various autoimmune disorders.”
Based on the evidence presented by studies like these, pharmaceutical CBD company Cardiol Therapeutics (TSX:CRDL,OTCQX:CRTPF) believes that there is an opportunity to develop a potential breakthrough CBD-based therapy for acute myocarditis. The company hopes that such a therapy will be eligible for designation as an orphan drug in the US and European Union. In November 2019, Cardiol formed a clinical steering committee made up of key opinion leaders in acute myocarditis from North America and Europe to guide a Phase 2 international trial in acute myocarditis using Cardiol’s pharmaceutically produced high-concentration cannabidiol formulation. The trial is being planned at world-renowned medical research institutes, including Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute and Charité University Medicine Berlin.
If Cardiol is successful in obtaining orphan drug designation, their pharmaceutically produced high concentration cannabidiol formulation would receive benefits in the US and Europe, including accelerated marketing approvals and an increased period during which Cardiol would have exclusive rights to market the drug for myocarditis treatment. Orphan drug designation is typically granted to incentivize the development of drugs for serious conditions that affect fewer than 200,000 people in the US or fewer than 5 in 10,000 people across the European Union.
“The US orphan drug program was successfully utilized to accelerate the first FDA approval of CBD for the treatment of rare forms of pediatric epilepsy,” stated David Elsley, president and CEO of Cardiol Therapeutics. “Given the mortality and the significant morbidity risk associated with acute myocarditis, we believe there is a similar opportunity in pursuing an expedited development program of our pharmaceutical CBD formulation for this serious orphan disease, which has no accepted standard of care.”
As CBD’s anti-inflammatory properties become better understood and documented, researchers could unlock its potential as a life-saving medicine. Exploration of this cannabinoid’s cardioprotective possibilities could offer a safe and effective approach to treating people afflicted with acute myocarditis.
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