Statement from Tetra Bio-Pharma on the legalization of recreational cannabis

ORLEANS, ON, Oct. 16, 2018 /CNW/ - October 17^th, 2018 will be remembered as one of the most significant dates in Canadian history, in our lifetime.

While there will continue to be arguments on both sides of the debate, the Government of Canada has legislated that adults will have access to cannabis for recreational use, subject to a set of guidelines that will vary from province to province.

Tetra Bio-Pharma (TSX VENTURE: TBP) (OTCQB: TBPMF), is a Canadian company that is a global leader in the discovery and development of cannabis and cannabinoid-based pharmaceuticals and is the only company in North America to work with both Health Canada and the U.S.  Food and Drug Administration on clinical programs to produce the rigorous scientific evidence required by these regulators as well as by medical professionals and insurance companies. If successful, the investigational trials will result in the manufacture of prescription drugs containing cannabis making these medications accessible to patients and reimbursed by private and public drug plans. These products will be produced for global markets including North America, Europe, South America and the Middle East. In addition to bio-pharma Tetra will introduce commercially available natural health products

While Tetra Bio-Pharma believes that cannabis has the potential to be of therapeutic benefit, as yet there is no scientific, safety, and efficacy data to support its usage. It is for this reason that we are pursuing a pharmaceutical pathway that is compliant with regulators, to establish the necessary clinical evidence that forms the basis of drug approvals. Health Canada, the United States Food and Drug Administration, and the European Medical Authority will only approve drugs for sale in these markets once they have successfully gone through a formal drug review process.  This process, which can take anywhere between 6 months and two years, is how a drug application is reviewed by scientists in the Health Products and Food Branch (HPFB) of Health Canada as well by other international regulating bodies and as required, outside experts, to assess the safety, efficacy and quality of a drug.¹  Throughout the process the well-being of patients is of paramount concern. Tetra Bio-Pharma is currently funding five Health Canada authorized clinical trials, including investigational trials for advanced cancer pain, a head to head trial comparing cannabis to fentanyl in breakthrough cancer pain, fibromyalgia, and chronic pain.

According to Dr. Guy Chamberland, Chief Executive Officer and Chief Scientific Officer of Tetra Bio-Pharma, "the millions of individuals who currently suffer from painful conditions like cancer pain and fibromyalgia, or other medical problems like insomnia, depression, anxiety may be opening themselves up to unnecessary health risks with the use of recreational cannabis. Our concern also extends to seniors, children and even pets, among the most vulnerable in our society where it may be believed that cannabis will relieve common aches and pains."

At this point in time, and as Canadians decide how to navigate the new frontier of widespread access to recreational cannabis, Tetra Bio-Pharma would like to remind all Canadians that cannabis is a drug.

• If you suffer from a health condition, do not take cannabis without your doctors' knowledge and follow-up.
• Treatment with cannabis is complicated. Consult a health professional or clinic with experience in treating with cannabis.
• Be aware that dosing with cannabis is important. When you take a Health Canada approved medication, the dose is exact. This is not the case with medicinal and recreational cannabis and you risk taking too much.
• Note that recreational cannabis will be different from lot to lot, week to week and month to month. The strain and amount that worked once, may not do so again.
• Cannabis is a drug. Like with other drugs, there can be side effects and interactions with other medications you might be taking. Ask a pharmacist or health professional if cannabis can interact with your current medications.
• If you try recreational cannabis and do not feel well, seek professional help.

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¹ https://spharm-inc.com/the-drug-approval-process-in-canada-an-eguide/

SOURCE Tetra Bio-Pharma

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