Tetra Bio-Pharma Subsidiary Finishes Phase 3 Topical Trial
Tetra Bio-Pharma’s (TSXV:TBP,OTCQB:TBPMF) subsidiary Panag Pharma announced the completion of its Phase 3 clinical trial of a topical, Awaye, treating pain caused by osteoarthritis of the knee.
As quoted in the press release:
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.
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.
“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.”
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