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May 02, 2019

Flexion Therapeutics Announces Upcoming Presentations at the 2019 Osteoarthritis Research Society International (OARSI) World Congress

  • Repeat Administration of Triamcinolone Acetonide Extended-Release Affords Consistent, Clinically Relevant Improvements in Pain: Results from a Phase 3b, Single-Arm, Open-Label Study (Poster 732)
  • Safety and Systemic Exposure of Triamcinolone Acetonide Following Intra-Articular Injection of Triamcinolone Acetonide Extended-Release or Standard Triamcinolone in Patients with Hip Osteoarthritis (Poster 731)
  • Dose-Dependent Chondroprotective Effects of Triamcinolone Acetonide on Inflamed and Injured Cartilage Using an In Vitro Model (Poster 230)
  • Flexion sponsored Satellite Lunchtime Symposia, “Considerations in the Chronic Management of Osteoarthritis” to be held today at 11:30 a.m. ET

BURLINGTON, Mass., May 02, 2019 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) will present data from three recent studies at the Osteoarthritis Research Society International (OARSI) World Congress taking place May 2-5, 2019 in Toronto, Canada.

“As a company focused on advancing innovative, local therapies for the treatment of osteoarthritis (OA), the OARSI World Congress provides us with a vital opportunity to engage in dialog with leading academic researchers and garner new insights into this chronic and painful condition,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “In particular, we are proud to sponsor an important luncheon symposium, which aims to foster critical discussions about the management of the patient with OA knee pain, including the use of corticosteroids.”

Flexion data presented at the 2019 OARSI World Congress includes the following:

Repeat Administration of Triamcinolone Acetonide Extended-Release Affords Consistent, Clinically Relevant Improvements in Pain: Results from a Phase 3b, Single-Arm, Open-Label Study (Poster 732)

  • Repeat administration of ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) tailored to patient symptoms was generally safe and well-tolerated, had no deleterious effect on cartilage or joint structure per x-ray, and resulted in substantial improvements in OA symptoms after both injections; and
  • More than 60% of patients demonstrated a substantial analgesic response with ≥50% improvement from baseline in WOMAC-A (pain), WOMAC-B (stiffness), WOMAC-C (function), or KOOS-QoL score after both the first and second injections of ZILRETTA.1,2

Safety and Systemic Exposure of Triamcinolone Acetonide Following Intra-Articular Injection of Triamcinolone Acetonide Extended-Release or Standard Triamcinolone in Patients with Hip Osteoarthritis (Poster 731)

  • ZILRETTA was generally safe and well-tolerated, and there were no serious adverse events (AEs) or AEs leading to treatment discontinuation;
    • No study drug related AEs occurred in the ZILRETTA treatment group.
  • The PK profile of ZILRETTA observed in the hip was consistent with previous PK studies in the knee showing some systemic absorption and a plateau in plasma triamcinolone acetonide (TA) concentration through Hour 24, followed by gradual systemic elimination; and
  • ZILRETTA injection into the hip resulted in lower peak plasma levels and reduced systemic exposure relative to triamcinolone acetonide crystalline suspension, a pattern similarly observed in knee OA. 

Dose-Dependent Chondroprotective Effects of Triamcinolone Acetonide on Inflamed and Injured Cartilage Using an In Vitro Model (Poster 230)

  • In an in vitro model, the administration of pro-inflammatory cytokines and/or mechanical injury to cartilage explants resulted in a reduction of cartilage matrix biosynthesis and an increase in cartilage matrix breakdown; and
  • The administration of TA in inflamed and/or injured cartilage tissue had protective effects, such as restoration of cartilage matrix biosynthesis and prevention of cartilage matrix breakdown, and no detrimental effects were observed at any dose in inflamed or injured cartilage.
  • The study was led by Professor Alan Grodzinsky, Sc.D., Director of the Center for Biomedical Engineering at the Massachusetts Institute of Technology.

Flexion will also sponsor a lunchtime satellite symposium entitled, “Considerations in the Chronic Management of Osteoarthritis” today at 11:30 a.m. ET in the Grand East Ballroom. The seminar will be led by Philip Conaghan, MBBS, Ph.D., FRACP, FRCP, Professor of Musculoskeletal Medicine and Director of the Leeds Institute of Rheumatic and Musculoskeletal Medicine at the University of Leeds and Andrew Spitzer, MD, Co-Director, Joint Replacement Program, Cedars-Sinai Orthopaedic Center.

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. The pivotal Phase 3 trial on which the approval of ZILRETTA was based showed that ZILRETTA significantly reduced knee pain for 12 weeks, with some people experiencing pain relief through Week 16. Learn more at www.zilretta.com.

About Osteoarthritis (OA) of the Knee
OA, also known as degenerative joint disease, affects more than 30 million adults living in the U.S. 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 a Top Place to Work in Massachusetts by The Boston Globe.

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; expected increases in the rate of individuals with OA of the knee; and 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 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 Annual Report on Form 10-K for the year ended December 31, 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. WOMAC (Western Ontario and McMaster Universities Arthritis Index) is a validated, widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness and physical functioning of the joints.

2. The KOOS (Knee Injury and Osteoarthritis Outcome Score) QoL (Quality of Life) subscale Assesses patients' perceptions about their treated knee and associated problems related to quality of life.

Contacts:

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

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

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Source: Flexion Therapeutics, Inc.