Panag Pharma Completes Phase 3 Trial With Awaye™
Recently acquired by Tetra Bio-Pharma, Panag Pharma’s terpene-derived topical product is aimed at pain caused by osteoarthritis of the knee
OTTAWA, June 11, 2019 (GLOBE NEWSWIRE) — Panag Pharma Inc., a subsidiary of Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX-V: TBP) (OTCQB: TBPMF), today announced completion of Panag 001, its Phase 3 clinical trial evaluating the safety and efficacy of Topical-A, now branded as Awaye™ for the treatment of pain caused by osteoarthritis of the knee. The last patient will be finished the open label phase this week and the last follow-up visits will be completed by the end of the third week of June. Panag will complete the analysis of the results and will communicate them to the market in the coming weeks. While the clinical study investigated the use of Awaye™ for osteoarthritis of the knee, it is currently approved by Health Canada for expanded indications including muscle and joint pain from arthritis.
About the Phase 3 Trial
The Phase 3 trial was a randomized, double-blind, placebo-controlled crossover trial with a 3-week open label extension. It was designed to demonstrate the safety and efficacy of its Awaye™ topical cream in participants with Osteoarthritis (OA) of the knee as per the criteria of the American College of rheumatology. The study design included 3 arms: placebo, Awaye™ and a third arm with a Beta-caryophyllene proprietary formulation. Patients received Awaye™ during the open label extension phase. Patients enrolled in the trial had osteoarthritis of the knee as per criteria established by the American College of Rheumatology. The Primary Endpoint of the study was the change in the mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to post treatment average for each treatment arm. Multiple Secondary Endpoints assessing pain, patient satisfaction and global impression of change were performed.
“This is the second study performed by Panag to demonstrate the safety and efficacy of Awaye™ in patients suffering from local pain,” says Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma. “Panag has been working with Tetra’s commercialization team and expects to bring this product to consumers in the fourth quarter of 2019. We are also in discussions with potential commercialization partners from around the world. Awaye™ will be marketed by Tetra Natural Health, a subsidiary of Tetra Bio-Pharma.”
About Panag Pharma:
Panag Pharma Inc. is a Canadian-based life sciences company recently acquired by Tetra Bio-Pharma that is focused on the development of novel cannabinoid-based formulations for the treatment of pain and inflammation. Panag believes that pain relief should be safe, non-addictive and above all, effective. The Panag Pharma team comprised of Ph.D. scientists and medical doctors are among the world’s leading researchers and clinicians in pain treatment and management. They bring a combined experience of over 100 years in research and the clinical care of people dealing with chronic pain and inflammatory conditions. Panag’s current pipeline of pain relief products include formulations for application to the skin, the eyes as well as other mucous membranes. Recently approved by Health Canada and currently undergoing clinical trials, Panag Pharma’s Awaye™ over the counter (OTC) cream provides a new approach to the treatment of chronic pain and inflammation.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with Health Canada authorized, and FDA reviewed, clinical trials 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.
Source: Tetra Bio-Pharma
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Tetra Natural Health Contact:
CEO, Tetra Natural Health
Pierre Boucher, CPA, CMA
Partner, Executive Vice-President
514-731-0000 ext. 237
Carol Levine, APR, FCPRS
514-288-8500 ext. 226