Health Canada has certified the first ever Canadian-owned pharmaceutical facility for the manufacture of prescription products containing cannabidiol (CBD).
This marks the first Health Canada certification for a new Canadian-owned company that has built a facility for prescription drugs in more than four decades.
Clinical trials are underway to advance a new CBD-based prescription medication for anxiety, Empower CBD™. Outcomes are intended to establish the required clinical safety and efficacy evidence to support a New Drug Submission (NDS) to Health Canada and a Regulatory Filing with the FDA at the earliest opportunity.
BURLINGTON, ON, June 7, 2021 /CNW/ – EmpowerPharm today announced they have been certified to manufacture products containing cannabidiol (CBD) to prescription drug standards – a Canadian first.
They have been granted a Drug Establishment Licence (DEL) by Health Canada for their new state-of-the-art pharmaceutical manufacturing facility in Burlington, Ontario. With this licence, EmpowerPharm is now certified as compliant with Good Manufacturing Practice (GMP) standards. They have previously received a Cannabis Drug Licence, a Standard Processing Licence and a Cannabis Research Licence.
With this new Health Canada licence, EmpowerPharm is well positioned to disrupt the pharmaceutical sector through further investment in its R&D. Healthcare practitioners and governments have long called for scientific evidence to support cannabis-based pharmaceutical products for therapeutic use.
Clinical Trials to Substantiate Empower CBD™ to Treat Anxiety
Clinical trials are underway to provide scientific evidence to support the safety, efficacy, and quality of Empower CBD™ as a prescription medication indicated for anxiety, administered by prescription under the direction of a qualified physician.
None of the cannabis products currently on the market used for anxiety are approved as prescription medicines by Health Canada, lacking the associated clinical evidence, prescribing information, standardized dosing and quality, product labelling and other important information for prescribers consistent with the highly regulated pharmaceutical sector.
EmpowerPharm’s intended use of synthetic CBD as its Active Pharmaceutical Ingredient (API) will ensure that their products are manufactured consistently to provide 99% CBD. This will provide quality assurances that products will not contain THC or any other unwanted cannabinoids that plant-based extracts may contain. Empower CBD™ will be manufactured and tested according to established pharmaceutical Good Manufacturing Practices (GMP) and will meet all regulatory requirements for API including product identity, potency, and purity.
Protecting Canadians against the next pandemic: Record spike in anxiety and depression
According to the Canadian Mental Health Commission, Canadians are facing a spike in anxiety due to COVID-19, and the effects will remain for years into the recovery effort. Results from a poll undertaken by Mental Health Research Canada in February 2021, demonstrate that 25% of Canadians self-report or have been diagnosed with anxiety – the highest levels of anxiety to date.1
Anxiety may prove to be a long-term challenge. Modelling undertaken by Deloitte projects mental health impacts due to COVID-19 may endure up to ten years in Canada. Even once the pandemic subsides, Deloitte projects a twofold increase in visits to mental health professionals for anxiety- related issues, and possibly a 20% increase in prescriptions for antidepressants, relative to pre- COVID levels. These challenges will impact women in particular, given their disproportionate employment in the service sector and low-income households.2
Based on Health Canada’s own Drug Establishment Licence (DEL) database, there are only five (5) Canadian-owned pharmaceutical manufacturers certified to manufacture oral dose prescription medicines to treat diseases, disorders, or abnormal physical states – four of which were established over four decades ago.3 Pandemic supply shortages in vaccines and the ongoing challenge of drug shortages for other products have illuminated why it has never been more important for Canada to build capacity in critical areas of pharmaceutical research, development and manufacturing.
EmpowerPharm is a new clinical-stage Canadian-owned pharmaceutical company established in 2018 by Aubrey Dan and Peter Billiaert, who collectively have over 55 years of experience in the pharmaceutical industry. The management team and board of directors include leaders of Canada’s pharmaceutical industry, who are supported by a leading medical advisory board and clinical advisory board. The team has extensive experience to execute on its corporate strategy to deliver a successful portfolio of products. EmpowerPharm has experts in R&D who have developed hundreds of drug molecules and know how to manufacture large volumes of dosages. Our team is experienced and has proven ability to navigate the highly complex international regulatory environments. Most importantly, our team has a proven track record of growing and scaling a profitable pharmaceutical company.
EmpowerPharm operates a state-of-the-art $30 million manufacturing facility in Burlington, Ontario. The facility includes production and pharmaceutical R&D equipment that is qualified and maintained to GMP standards, which represents the highest standard of quality. This is coupled with a quality management system, which was essential to EmpowerPharm obtaining its DEL for the manufacturing of Empower CBDTM. EmpowerPharm is the first dedicated pharmaceutical company to have a manufacturing facility with a Drug Establishment Licence (DEL) that is built for cannabinoid-based pharmaceuticals in Canada that is federally approved. This facility allows EmpowerPharm to manage its R&D in-house and to scale its production without reliance on third party manufacturers.
1 Mental Health Research Canada.” Findings of Poll #5″. Mental Health in Crisis: How COVID is impacting Canadians. (With financial contribution from Health Canada). Source: Website: https://www.mhrc.ca/national-poll-covid/findings-of-poll-5, March 17, 2021.
2 Deloitte Canada. “Uncovering the hidden iceberg: Why the human impact of COVID-19 could be a third crisis.” Report (August 2020). Source: Website, March 17, 2021.
3 Health Canada. “Drug and Health Product Inspection Database (DHPID)”. Health Canada website. Source, May 3, 2021.
EmpowerPharm is dedicated to providing the science and evidence physicians so critically need to confidently prescribe new drugs. Our goal is to become a global pharmaceutical leader in CBD- based therapeutic products. Our aim is to be a disruptive force for good by creating more effective pharmaceutical treatments without the addictive side effects of traditional therapeutic drug classes.
SOURCE EmpowerPharm Inc.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/June2021/07/c2134.html