ORLEANS, Ontario, Sept. 13, 2018 (GLOBE NEWSWIRE) — Tetra Bio-Pharma Inc. (“Tetra” or the “Corporation“) (TSX VENTURE: TBP) (OTCQB: TBPMF), a global leader in cannabinoid-based drug development and discovery, announced today that Health Canada has re-classified the inhalation pipe device used in the delivery of its PPP001 cannabis drug to a Class 2 Medical Device. The reclassification will help pave the way towards reimbursement for patients; a key element to patient access and care. The significance of this decision is such that if PPP001 is approved by Health Canada, both the prescription drug and the inhalation device will be eligible for insurance coverage by private and provincial public insurance plans. Tetra Bio-Pharma is undertaking a Phase III trial with PPP001 treating late stage cancer patients looking to improve quality of life and reduce pain. The Company also recently announced it is starting a head to head trial to investigate cannabis versus Fentanyl in managing breakthrough cancer pain.
“We are very excited by the reclassification as we believe it will provide patients with a financial benefit in terms of coverage for the device and prescription drug,” stated Dr. Guy Chamberland, Ph.D., Interim CEO and CSO at Tetra Bio-Pharma. “Many cancer patients rely on private and public insurance plans for access to their medication. This decision by the Government of Canada is an important step forward to facilitating access to cannabis drugs. This coupled with our robust clinical trial program and the evidence we are establishing will support physicians in discussing and recommending this option with their patients.”
Dr. Chamberland further stated, “the lack of scientific data on the safety and efficacy of cannabis is a critical barrier to patient access, and something that Canadian physicians are waiting for before being comfortable to prescribe it. Equally essential is adhering to the highest standards of drug manufacturing as well as the production of the delivery mechanism – something that Tetra is committed to. There are more than 300,000 registered users of medical cannabis in the country and we can only expect this number to rise.”
Tetra has been a pioneer in the development of several cannabis drugs. To date, the Corporation has completed several safety and pharmacokinetic studies in healthy volunteers obtaining proper dosing information and a clear understanding of the potential cardiovascular and neurological risks to patients. This information is critical to protect public health, and Tetra Bio-Pharma is engaged with Health Canada to comply with the highest drug safety standards.
A bout Tetra Bio-Pharma Inc.
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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