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Aug 20, 2018

Flexion Therapeutics Announces Presentation of Phase 3 Data at Military Health System Research Symposium

  • Military Health System provides healthcare to more than nine million people; the research symposium highlights scientific advancements that impact military medicine 
  • Osteoarthritis is a leading cause of disability discharge from the military
  • Post-hoc analysis showed those treated with ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) felt significant, sustained improvements in knee pain

BURLINGTON, Mass., Aug. 20, 2018 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today presented data from a previously reported post-hoc analysis of ZILRETTA (triamcinolone acetonide extended-release injectable suspension) in an oral session at the Military Health System Research Symposium (MHSRS) in Kissimmee, Florida. The analysis evaluated the efficacy of ZILRETTA in people with unilateral osteoarthritis (OA) knee pain from the pivotal Phase 3 trial.

OA of the knee affects more than 15 million Americans, including active-duty military personnel who are more likely to experience OA than those in non-tactical professions.1 Each year, approximately 11,000 active-duty service members are diagnosed with OA, which is also a leading cause of disability discharge due to the debilitating nature of the disease.1, 2

“The physically demanding nature of their work puts members of our armed forces at an increased risk of developing OA of the knee,” said Scott Kelley, M.D., Chief Medical Officer of Flexion. “MHSRS affords us an opportunity to present the clinical benefits of ZILRETTA as a non-opioid treatment for OA knee pain to military healthcare providers and share how it can address this important area of unmet medical need.” 

The MHSRS is the premier scientific meeting for the Department of Defense and focuses on the unique medical needs of military service members. Nearly 3,000 people attend the educational symposium to hear the latest advancements in military-related research and healthcare initiatives. Presentations over the four days cover a broad range of topics including the need for non-opioid approaches to pain management. The Military Health System provides care to approximately 9.4 million active duty service members, military retirees, and their families.

The post-hoc analysis of patients with unilateral knee OA pain from the Phase 3 study demonstrated that ZILRETTA provided significant improvement in pain at Week 12 compared with placebo (P<0.0001) and immediate release triamcinolone acetonide (TAcs) (P<0.01). Those treated with ZILRETTA also appeared to have sustained response over placebo and TAcs with respect to improvements in pain, stiffness, and physical function at Weeks 4, 8, and 12 (measured through standardized, verified instruments; P<0.05 for all instruments).

These results were previously presented at the Academy of Managed Care Pharmacy (AMCP) 2018 Annual Meeting in April.

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; expected increases in the rate of individuals with OA of the knee; the potential therapeutic and other benefits of ZILRETTA; and opportunities to obtain regulatory approval for further indications for 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 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. Cameron KL, Driban JB, Svoboda SJ. Osteoarthritis and the tactical athlete: A systematic review. J Athl Train. 2016; 51(11).
  2. Cameron KL, Hsiao MS, Owens BD, Burks R, Svoboda SJ. Incidence of physician-diagnosed osteoarthritis among active duty United States military service members. Arthritis Rheum. 2011; 63(10): 2974-82.

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.