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Panag Pharma Completes Phase 3 Trial With Awaye™
Panag Pharma Completes Phase 3 Trial With Awaye™.
About this update from Tetra Bio-pharma Inc.
[{"type":"text","content":"\nOTTAWA, 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.\n About the Phase 3 TrialThe 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-Phar...