A Made-in-Canada solution can ensure Canadians are prepared for the impending mental health crisis

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Oct 27, 2020, 11:07 ET

EmpowerPharm Inc. is developing an innovative prescription CBD therapy that may be a game-changer for treating anxiety

TORONTO, Oct. 27, 2020 /PRNewswire/ - Hundreds of thousands of Canadians are facing a mental health crisis due to the far-reaching ripple effects of COVID-19, and one homegrown company is working to ensure support to the country. EmpowerPharm Inc., a wholly Canadian-owned and operated pharmaceutical company, is developing a first-of-its-kind prescription tablet containing synthetic CBD to treat anxiety without the serious potential side-effects associated with some current prescription drugs.

EmpowerPharm's first-of-its-kind prescription tablet containing synthetic CBD will treat anxiety without the serious potential side-effects associated with some current prescription drugs. (CNW Group/EmpowerPharm Inc.)

The COVID-19 pandemic is deteriorating Canadians' mental health, and physicians and policymakers have voiced their concerns that the country may not be fully prepared to deal with this pandemic consequence. EmpowerPharm has identified the growing need for innovative therapies to treat anxiety and is ushering in a new era for prescription medicine with the made-in-Canada solution.

"We've heard from physicians on our medical advisory board that they want alternative prescription medicines than what are currently available," says Aubrey Dan, Executive Chairman & Co-Founder. "Anxiety is typically treated with benzodiazepines, which come with a number of side-effects that patients want to avoid, including the potential for addiction and cognitive impairment."

Pending clinical research results, Empower CBD^TM may help many Canadians manage the anxiety that they're experiencing as a consequence of the COVID-19 pandemic. The Empower CBD^TM tablets, which contain synthetic CBD as the active Ingredient (API), will be 99% pure with zero THC. EmpowerPharm will be going through the rigorous clinical studies for approval by national regulatory authorities including Health Canada and the U.S. Food and Drug Administration.

An article published October 12 in JAMA (Journal of the American Medical Association) noted "rising rates of mental health and substance use disorders. This imminent mental health surge will bring further challenges for individuals, families, and communities." The article follows a report by Mental Health Research Canada in September which found high levels of anxiety and depression were slowly climbing across Canada: 20% of the population had anxiety in April. That number rose to 22% in August. Meanwhile, 10% of the population reported depression in April and that number rose to 13% in August.

"Physicians and patients may have anecdotal experience that CBD can be effective in treating anxiety. However, the CBD present in natural cannabinoids, which are approved by Health Canada for medical use, can hardly undergo rigorous clinical trials as it is almost impossible to ensure batch to batch quality and consistency. Furthermore, the proper titration of natural CBD is often challenged by the co-existence of THC which is contraindicated in certain patients., says Dr. Antonio Vigano, Associate Professor in Oncology and co-lead, bio-medical axis, McGill Research Centre for Cannabis, McGill University.

"Physicians are looking for a CBD product that has been clinically tested, was found to be safe and effective at specific doses and was approved by Health Canada," adds Dr. Vigano, who is also a member of the EmpowerPharm Medical Advisory Board.

Another recurring issue witnessed throughout the COVID-19 pandemic is the potential difficulties of securing essential medicines from outside the country. Having a made-in-Canada product is the only way to ensure Canadian patients will have secure access to necessary treatments.

Once Empower CBD^TM is proven safe and effective through rigorous clinical research, a Drug Identification Number (DIN) will be sought from Health Canada. The Empower CBD^TM will be sold exclusively through pharmacies or dispensed in hospitals by qualified health professionals as any other prescription drug. EmpowerPharm Inc. will pursue both private and public coverage, ensuring that treatment costs for many patients will be reimbursed by insurance companies and/or provincial drug plans for wide patient accessibility.

EmpowerPharm is led by three prominent leaders who pioneered Canada's generic pharmaceutical industry, helped scale the industry globally and created thousands of Canadian jobs. Each member of the senior management team brings an average 30 years of industry experience to the company. Aubrey Dan, O.C., Executive Chairman & Co-Founder is a former pharmaceutical executive at Novopharm Ltd., President of Wampole Canada Inc. and Order of Canada recipient, Peter Billiaert President & Co-Founder is a former Vice President with Novopharm Ltd. and Teva Pharmaceuticals and Jack Kay, Vice Chairman, is the former President and CEO of Apotex Inc.

SOURCE EmpowerPharm Inc.