FLXN Flexion Therapeutics Inc

Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced results from two analyses of the company’s recently-approved drug Zilretta™ (triamcinolone acetonide extended-release injectable suspension), the first and only extended-release, intra-articular (IA) injection for the management of osteoarthritis (OA) knee pain. The clinical findings will be presented at the 2017 American College of Rheumatology (ACR) Annual Meeting, taking place November 3-8 in San Diego.

Zilretta is a non-opioid medicine that employs Flexion’s proprietary microsphere technology. Zilretta was approved by the U.S. Food and Drug Administration (FDA) on October 6, 2017 as an IA injection for the management of OA pain of the knee. The approval was based upon data from Flexion’s pivotal Phase 3 clinical trial, a randomized, double-blind study, which enrolled 484 patients at 37 centers worldwide.

“The data presented at ACR further affirm the effectiveness of Zilretta in providing extended relief of OA knee pain,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “The growing body of data surrounding Zilretta continues to demonstrate the important role this product may play for the millions of Americans suffering from this debilitating disease.”

Clinical Data Presentations:

Title: Effectiveness of FX006 Intra-Articular Injection in Patients with Knee Osteoarthritis who Present with and without Clinical Inflammation at Baseline: A Pooled Analysis of Data from 3 Double-Blind, Randomized, Parallel-Group Clinical TrialsPresentation: 934Date and Time: Sunday, November 5, 2017; 4:30 PM - 6:00 PM

The investigators conducted a pooled subgroup analysis of three double‐blind, randomized, placebo‐controlled Phase 2/3 trials of patients with knee OA to compare the efficacy of Zilretta (FX006) in patients with and without baseline inflammation as determined by clinical assessment. Patients received a single IA injection of Zilretta 32 mg or saline‐placebo. Average Daily Pain (ADP)-intensity was assessed for 24 weeks and WOMAC pain (A), stiffness (B) and physical function (C) were assessed at baseline and Weeks 4, 8, 12, 16, 20 and 24.1 Of the 586 study patients, 349 or 60% of patients with knee OA had baseline inflammation.

Results showed that Zilretta provided sustained clinical improvement in OA knee pain vs. saline-placebo. Furthermore, the effect of Zilretta was generally enhanced more than two-fold in patients with baseline inflammation versus those without inflammation.

Title: Updating the Knee Osteoarthritis Intra-Articular Corticosteroid Meta-Analysis with Two Large Trials of Extended-Release Triamcinolone Acetonide (FX006) Versus PlaceboPoster: 1200Date and Time: Monday, November 6, 2017; 9:00 AM - 11:00 AM

To assess the clinical relevance of Zilretta (FX006), a recent meta-analysis was updated to include data from two large, randomized, placebo‐controlled Phase 2/3 trials of Zilretta in patients with knee OA. In the studies, patients with OA of the knee received a single IA injection of Zilretta 32 mg or saline‐placebo. ADP was collected for 24 weeks and standardized mean difference was computed for ADP-intensity at Weeks 2, 6, 12 (3 months) and 24 (6 months) post-treatment. The expanded meta-analysis appeared to demonstrate that Zilretta provided greater pain relief through three months compared with traditional IA corticosteroids, further supporting the clinical relevance of Zilretta as beneficial for treating OA knee pain.

Zilretta is now commercially available in the U.S. For more information, visit www.zilretta.com or call 1-844-FLEXION. 

Indication and Important Safety Information

Indication: ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee.

Limitations of Use: ZILRETTA 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. Serious events have been reported with epidural and intrathecal administration of corticosteroids and none are approved for this use. ZILRETTA should not be considered safe for epidural or intrathecal administration.
• Hypersensitivity Reactions: Rare instances of anaphylaxis, including serious cases, have occurred in patients with hypersensitivity to corticosteroids.
• Joint Infection and Damage: A marked increase in pain accompanied by local swelling, restriction of joint motion, fever and malaise are suggestive of septic arthritis. Examine joint fluid to exclude a septic process. If diagnosis is confirmed, institute appropriate antimicrobial therapy. Avoid injecting corticosteroids into a previously infected or unstable joint. Intra-articular administration may result in damage to joint tissues.
• Increased Risk of Infections: Infection with any pathogen in any location of the body may be associated with corticosteroid use. Corticosteroids may increase the susceptibility to new infection and decrease resistance and the ability to localize infection.
• Alterations in Endocrine Function: Corticosteroids can produce reversible hypothalamic-pituitary-adrenal axis suppression, with potential for adrenal insufficiency after withdrawal of treatment, which may persist for months. In situations of stress during that period, institute corticosteroid replacement therapy.
• Cardiovascular and Renal Effects: Corticosteroids can cause blood pressure elevation, salt and water retention and increased potassium excretion. Monitor patients with congestive heart failure, hypertension and renal insufficiency for edema, weight gain and electrolyte imbalance. Dietary salt restriction and potassium supplementation may be needed.
• Increased Intraocular Pressure: Corticosteroid use may be associated with increased intraocular pressure. Monitor patients with elevated intraocular pressure for potential treatment adjustment.
• Gastrointestinal Perforation: Corticosteroid administration may increase risk of gastrointestinal perforation in patients with certain GI disorders and fresh intestinal anastomoses. Avoid corticosteroids in these patients.
• Alterations in Bone Density: Corticosteroids decrease bone formation and increase bone resorption. Special consideration should be given to patients with or at increased risk of osteoporosis prior to treatment.
• Behavior and Mood Disturbances: Corticosteroids may cause adverse psychiatric reactions. Prior to treatment, special consideration should be given to patients with previous or current emotional instability or psychiatric illness. Advise patients to immediately report any behavior or mood disturbances. 

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

Please see the full Prescribing Information at www.ZILRETTAlabel.com.

*The efficacy and safety of repeat administration of ZILRETTA have not been evaluated.

About Zilretta Zilretta is the first and only FDA-approved 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 specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA, a type of degenerative arthritis. The company's core values are focus, ingenuity, tenacity, transparency and fun. Flexion was named one of the Boston Business Journal's 2017 Best Places to Work.

Forward-Looking StatementsStatements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; timing for the expected commercial availability of Zilretta; our plans to commercialize Zilretta and its market potential; 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 the process of launching a new pharmaceutical product in the United States; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to Zilretta; competition from alternative therapies; the risk that we may not be able to successfully hire, train and maintain an effective sales force to commercialize 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 payors 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; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our most recent Annual Report on Form 10-K 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.

Contacts:

Scott YoungSr. Director, Corporate Communications & Investor RelationsFlexion Therapeutics, Inc.T: 781-305-7194syoung@flexiontherapeutics.com

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

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.