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Sep 10, 2018

Flexion Therapeutics Announces Publication of Phase 2 Diabetes Data in September Issue of Rheumatology

  • 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

BURLINGTON, Mass., Sept. 10, 2018 (GLOBE NEWSWIRE) -- 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.

“Managing osteoarthritis knee pain with immediate-release corticosteroids in the diabetic patient population can be challenging as blood glucose levels often increase substantially following injection,” said Michael Clayman, M.D., President and Chief Executive Officer. “The publication of these data in Rheumatology further validates the value of ZILRETTA’s extended-release profile by demonstrating its potential to limit systemic effects on blood glucose levels in patients with Type 2 diabetes, which represents an important segment of people who are also confronting osteoarthritis knee pain.” 

Incidences of adverse events (AEs) in the study were low and similar between the ZILRETTA and TAcs treatment arms. All AEs were Grade 1 (ZILRETTA: 0/18, 0%; TAcs: 2/15, 13.3%) or Grade 2 (ZILRETTA: 2/18, 11.1%; TAcs: 0/15, 0%). No patients treated with ZILRETTA experienced an index-knee or injection-related AE.

Indication and Select Important Safety Information for ZILRETTA

Indication: ZILRETTA is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. It is not intended for repeat administration.

Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.

Warnings and Precautions:

  • Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. ZILRETTA should not be considered safe for epidural or intrathecal administration.
  • Serious Neurologic Adverse Reactions with Epidural and Intrathecal Administration: Serious neurologic events have been reported following epidural or intrathecal corticosteroid administration. Corticosteroids are not approved for this use.
  • Hypersensitivity reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care if an anaphylactic reaction occurs.
  • Joint infection and damage: A marked increase in joint pain, joint swelling, restricted motion, fever and malaise may suggest septic arthritis. If this occurs, conduct appropriate evaluation and if confirmed, institute appropriate antimicrobial treatment.

Adverse Reactions: The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough, and contusions.

Please see ZilrettaLabel.com for full Prescribing Information.

About ZILRETTA
On October 6, 2017, ZILRETTA was approved by the U.S. FDA as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis-related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonide — a commonly administered, short-acting corticosteroid — with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief over 12 weeks.

About Osteoarthritis (OA) of the Knee
OA, also known as degenerative joint disease, affects more than 30 million Americans and accounts for more than $185 billion in annual expenditures. In 2016, more than 15 million Americans were diagnosed with OA of the knee and the average age of physician-diagnosed knee OA has fallen by 16 years, from 72 in the 1990s to 56 in the 2010s. The prevalence of OA is expected to continue to increase as a result of aging, obesity and sports injuries. Each year, more than 15 million Americans are treated for OA-related knee pain, and approximately five million OA patients receive either an immediate-release corticosteroid or hyaluronic acid intra-articular injection to manage their knee pain.

About Flexion Therapeutics
Flexion Therapeutics (Nasdaq:FLXN) is a biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, a type of degenerative arthritis. The company's core values are focus, ingenuity, tenacity, transparency and fun. For the past two years, Flexion has been named one of the Best Places to Work by the Boston Business Journal, and Flexion was also recognized as a Top Place to Work in Massachusetts by The Boston Globe in 2017.

Forward-Looking Statements
This release contains forward-looking statements that are based on the current expectations and beliefs of Flexion. Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; ZILRETTA's market potential and potential benefits; and expected increases in the rate of individuals with OA of the knee; the potential therapeutic and other benefits of ZILRETTA, are forward-looking statements. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with developing and obtaining regulatory approval for product candidates; the fact that results of past clinical trials may not be predictive of subsequent trials; risks associated with commercializing new pharmaceutical products in the United States; the risk that we may not be able to successfully maintain an effective sales force or product supply to commercialize ZILRETTA; competition from alternative therapies; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to ZILRETTA; the risk that ZILRETTA may not be successfully commercialized, including as a result of limitations in ZILRETTA's label and package insert information; risks regarding our ability to obtain adequate reimbursement from payers for ZILRETTA; risks related to the manufacture and distribution of ZILRETTA, including our reliance on sole sources of supply and distribution; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; the risk that we may use our capital resources in ways that we do not currently expect; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2018 filed with the SEC on August 7, 2018 and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

References:

  1. Russell SJ, Sala R, Conaghan PG, et al. Triamcinolone acetonide extended-release in patients with osteoarthritis and Type 2 diabetes: a randomized, phase 2 study. Rheumatology. 2018; https://doi.org/10.1093/rheumatology/key265  
  2. American Diabetes Association. Accessed July 31, 2018. Available at: http://www.diabetes.org/diabetes-basics/statistics/ 

Contacts:

Scott Young
Vice President, Corporate Communications & Investor Relations
Flexion Therapeutics, Inc.
T: 781-305-7194
syoung@flexiontherapeutics.com

Julie Downs
Manager, Corporate Communications
Flexion Therapeutics, Inc.
T: 781-305-7137
jdowns@flexiontherapeutics.com

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Source: Flexion Therapeutics, Inc.