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Orphan Drug Designation Is Proven Path for CBD -- SECFilings.com
Redondo Beach, California--(Newsfile Corp. - August 5, 2020) - SECFilings.com, a leading finan...
About this update from Cardiol Therapeutics Inc. Class A
[{"type":"text","content":"Orphan Drug Designation Is Proven Path for CBD -- SECFilings.comRedondo Beach, California--(Newsfile Corp. - August 5, 2020) - SECFilings.com, a leading financial news and information portal offering free real time public company filing alerts, announces the publication of an article discussing how the past success of the orphan drug designation informs Cardiol Therapeutics Inc.'s (TSX: CRDL) (OTCQX: CRTPF) effort to develop CBD as a treatment for acute myocarditis. The Canadian-based company is utilizing pharmaceutical CBD in its research programs focused on various forms of heart failure and is preparing to launch its own brand of pharmaceutical CBD into the Canadian medical cannabis marketThe only cannabidiol (CBD) drug approved by the U.S. Food and Drug Administration (FDA) to date is Epidiolex®. Developed by GW Pharmaceuticals, Epidiolex is approved for the treatment of two rare forms of epilepsy-rare enough to meet the FDA guidelines for orphan disease designation because they affect less than 200,000 people in the U.S. In some ways, GW Pharma's success is a roadmap for capitalizing on the potential therapeutic benefits of CBD in these early days of cannabis drug development.Acute Myocarditis as Orphan DiseaseTo qualify for the FDA's orphan drug designation, the target disease has to affect less than 200,000 Americans. For instance, Epidiolex® was approved based on diseases that affect around 37,000 US residents. The orphan drug program was established by the FDA to incentivize companies to develop therapies for rare diseases that might otherwise be overlooked. It has worked. Since the passing of the Orphan Drug Act in 1983, over 600 drugs have been developed for diseases that meet its criteria, an average of about 150 per decade. In the ten years prior to the introduction of this program, fewer than ten such drugs came to market.Acute myocarditis is the leading cause of sudden cardiac death among people younger than 35 years of age. It is thought to affect around 22 out of every 100,000 people, equating to approximately 73,000 Americans. It is characterized by excessive inflammation of heart tissue, most often following a viral infection, and is believed to be the result of an immune response to the infection. This process results in increased apoptosis (death) of cardiac cells and an impairment to cardiac funct...