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Synthetic, Prescription Cannabidiol (CBD)

EmpowerPharm is developing a synthetic, prescription cannabidiol (CBD), designed to be consumed orally in a tablet format. We source our synthetic CBD API from a Canadian supplier with a GMP facility approved by Health Canada.

Empower CBD™ will be sold exclusively through pharmacies and hospitals and require a doctor’s prescription, allowing many sufferers to get the drug cost reimbursed from participating insurance companies and provincial formularies for wide patient accessibility.

EmpowerPharm seeks approvals by national regulatory authorities, such as Health Canada and the Food and Drug Administration (FDA), for its pharmaceutical-grade prescription product, Empower CBD™. These applications will be made after clinical research to prove safety and efficacy.

Anecdotally, CBD has become a well-known alternative to treat many diseases and symptoms. EmpowerPharm has a targeted scientific approach which is expected to be supported by full clinical studies to treat anxiety. This will ‘Empower’ sufferers to use an alternative treatment to avoid the potentially addictive products currently prescribed.

Fact

As many as 10% of the global population suffers from anxiety (over 780M people)¹ with the Canadian and US markets comprising of over 30%².

Source: 1. World Health Organization, Depression Fact Sheet; World Health Organization, Investing in Treatment for Depression and Anxiety (2016) 2. IQVIA, ForecastLink Query Builder (Aug 2020)

EmpowerPharm has no association with the cannabis industry. We are a pharmaceutical company creating an approved oral solid dosage form therapy, utilizing synthetic CBD and no plant material.

Our Intent

We intend to address a need in the global medical community for a non-addictive treatment for anxiety disorders. Today, many patients suffering from these conditions are prescribed antidepressants, benzodiazepines, anticonvulsants, and antipsychotics, which can all cause severe side effects. Benzodiazepines are known to be highly addictive. CBD is seen as a safer alternative treatment for such disorders; however, there is currently no prescription CBD tablet with 0% tetrahydrocannabinol (THC) content. With EmpowerPharm’s prescription tablet, Empower CBD™, sufferers will have an alternative solution, which we anticipate to be widely distributed and accepted by the medical community, formularies, third-party insurers and government payers.

What is Anxiety

Anxiety disorders are primarily characterized by overwhelming anxiety and fear, and are among the most prevalent mental health disorders. They are typically chronic, last at least six months, and are likely to get progressively worse without treatment.

The cause of anxiety is most likely to include genetic, environmental, and brain chemistry factors. The most common pharmacological therapies include antidepressants, anxiolytics, benzodiazepines, and to a lesser extent antipsychotics and anticonvulsants as adjunct therapies. These solutions may result in a number of side effects such as addiction.

How is CBD currently regulated in Canada?

The Cannabis act and its regulations control the production, distribution, sale and possession of cannabis across Canada. Currently, CBD is regulated under The Cannabis Act whether sourced from a cannabis plant or from a synthetic source. Per Government of Canada, products containing CBD can be considered to fall into one of three different categories* below:

Recreational Cannabis

Medical Cannabis

Prescription

* Exception: limited parts of cannabis or hemp plants, which must contain less than 0.3% (w/w) THC and may contain CBD, can be utilized as a non-active ingredient in natural health products and consumer products like creams, lotions and sports drinks. Currently, no CBD health claims are permitted for these  products.