Flexion Therapeutics Announces Publication of Phase 2 Diabetes Data

• Phase 2 data evaluating ZILRETTA^® (triamcinolone acetonide extended-release injectable suspension) in patients with Type 2 diabetes demonstrated lower blood glucose levels following ZILRETTA injection compared to TAcs injection
• Approximately 30% of patients with Type 2 diabetes also have osteoarthritis of the knee

Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that data from a Phase 2 study of ZILRETTA (triamcinolone acetonide extended-release injectable suspension) evaluating blood glucose levels in patients with osteoarthritis knee pain and Type 2 diabetes were published in the online edition of Rheumatology. The Phase 2, double-blind, randomized study met its primary endpoint demonstrating the change in blood glucose levels was significantly lower following ZILRETTA injection than immediate-release triamcinolone acetonide in crystalline suspension (TAcs) injection in people with osteoarthritis knee pain and Type 2 diabetes.

An estimated 29 million Americans are living with Type 2 diabetes and approximately 30% of them also have osteoarthritis of the knee.^1,2 Intra-articular corticosteroids are commonly used to manage osteoarthritis pain and inflammation and may affect blood glucose levels. Changes in blood glucose levels can pose critical clinical challenges for people with Type 2 diabetes. Recurrent and unaddressed hyperglycemia can lead to ketoacidosis (diabetic coma), kidney damage, heart disease and other serious complications.

“These data show that ZILRETTA did not significantly disrupt glycemic control, an important factor when considering a treatment option to help manage osteoarthritic knee pain for people with diabetes,” said Steven J. Russell, M.D., Ph.D., Associate Professor of Medicine, Massachusetts General Hospital Diabetes Research Center. “Osteoarthritis pain can have a serious impact on people’s lives and those with diabetes face the additional challenge of managing their blood glucose levels to avoid complications from the disease. Therefore it is valuable to have a treatment option that may avoid the blood glucose elevations commonly encountered with intra-articular injection of corticosteroids.”

The primary endpoint compared the change in average glucose values from the period of 72 hours before to the period 72 hours after injection with ZILRETTA versus TAcs. Key findings and conclusions showed:

• Change in average daily glucose levels were significantly lower in the 72 hours following injection of ZILRETTA compared to TAcs with a difference of 19.2mg/dL (p=0.0452);
• Blood glucose increase after injection was statistically significant in those treated with TAcs (p=0.0354), but not in those treated with ZILRETTA (p=0.6665);
• Average daily and hourly blood glucose levels 1-3 days following ZILRETTA injection were well within the American Diabetes Association-recommended target range; and
• ZILRETTA administration appeared to be associated with minimal disruption of glycemic control in people with osteoarthritis knee pain and Type 2 diabetes.

https://www.marketscreener.com/FLEXION-THERAPEUTICS-INC-15749853/news/Flexion-Therapeutics-Announces-Publication-of-Phase-2-Diabetes-Data-in-September-Issue-of-Rheumatolo-27237091/