Flexion Therapeutics Submits New Drug Application for Zilretta™ to Treat Knee Osteoarthritis Pain

BURLINGTON, Mass., Dec. 12, 2016 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead investigational product candidate Zilretta (also known as FX006), which is being evaluated to treat patients with osteoarthritis (OA) of the knee. Zilretta has received Fast Track designation from the FDA, a designation granted to drugs intended to treat serious conditions with the potential to provide meaningful improvement over existing therapies. Since the Zilretta NDA is being submitted as a 505(b)(2) application, FDA has up to 74 days to inform Flexion if the submission has been deemed complete and permits a full review.

“The submission of our first NDA is a major milestone for Flexion Therapeutics. Based on our pivotal data, we believe that Zilretta has the potential to be the first intra-articular, extended-release treatment for the many millions of patients who suffer with knee OA,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “I am grateful to our dedicated employees, clinical collaborators and board of directors for their commitment to advancing novel therapeutics that address unmet medical needs for patients with musculoskeletal conditions.”

The Zilretta NDA for OA of the knee is supported by previously reported results from a pivotal Phase 3 clinical trial. The randomized, double blind, placebo and active-comparator (immediate-release triamcinolone acetonide (TA)) controlled trial enrolled 484 patients at 37 centers worldwide. Data from the trial showed that Zilretta demonstrated a highly significant (p<0.0001) reduction in average daily pain versus placebo at week 12 (primary endpoint), with durable and clinically meaningful pain relief in patients with moderate to severe OA knee pain. In addition, compared to immediate-release TA, the most commonly injected intra-articular corticosteroid, Zilretta achieved statistical significance through 12 weeks on WOMAC A1 (pain), WOMAC B (stiffness) and WOMAC C (function). The frequency of treatment-related side effects was comparable across all treatment arms in the trial. The most common adverse events for Zilretta with an incidence greater than 2% were arthralgia, headache, joint swelling and back pain. No drug-related serious adverse events were observed and no patients treated with Zilretta were discontinued from the study due to a treatment-related side effect.

About Osteoarthritis of the Knee
While OA is currently being diagnosed at increasingly younger ages, prevalence rises after age 45. In 2015, more than 14 million Americans were diagnosed with OA of the knee. OA represents an enormous burden on the U.S. healthcare system, affecting more than 27 million individuals and accounting for more than $185 billion in annual expenditures. These costs will likely increase further as the prevalence of OA is anticipated to grow substantially, affecting 67 million Americans by 2030.

Each year, more than five million OA patients in the United States receive immediate-release corticosteroid and hyaluronic acid intra-articular injections for knee pain.

About Zilretta
Zilretta is being investigated as the first intra-articular, extended-release treatment for patients with knee OA pain. Zilretta employs proprietary microsphere technology combining TA – a commonly administered, short-acting corticosteroid – with a poly lactic-co-glycolic acid (PLGA) matrix. In 2015 the FDA granted “Fast Track” status to Zilretta, a designation which recognizes OA as a serious disease and the potential of Zilretta to be better than available therapies. We believe Zilretta is the first therapy for OA pain to receive the Fast Track designation. To date, more than 600 patients have been treated with Zilretta in clinical trials.

About Flexion Therapeutics
Flexion 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. The company's lead product candidate, Zilretta, is being investigated for its potential to provide improved analgesic therapy for the millions of U.S. patients who receive intra-articular injections for knee OA pain annually.

Forward-Looking Statements
Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; our plans to commercialize Zilretta; the potential therapeutic and other benefits of Zilretta and expectations regarding the future prevalence and impact of OA, 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 discovering, developing, manufacturing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics; our reliance on third parties to manufacture and conduct clinical trials of Zilretta, which could delay or limit its future development or regulatory approval; our ability to meet anticipated regulatory approval and commercial launch dates for Zilretta; the fact that we will require additional capital, including to fully commercialize Zilretta or any other product candidates, and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to us; 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; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory approvals to market Zilretta; the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of Zilretta and may require us to conduct additional clinical trials; Zilretta may not receive regulatory approval or be successfully commercialized, including as a result of the FDA's or other regulatory authorities' decisions regarding labeling and other matters that could affect its availability or commercial potential; 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.

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.


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