BURLINGTON, Mass., Nov. 03, 2016 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that
further analysis of Phase 3 data evaluating its investigational product, Zilretta™ (also known as FX006), in patients with
osteoarthritis (OA) of the knee will be presented during the 26th American Association of Hip and Knee Surgeons Annual
Meeting, taking place in Dallas from November 10-13, 2016.
Results will be presented during a podium presentation by Andrew Spitzer, M.D., Co-Director of the Joint Replacement Program at
Cedars-Sinai Orthopaedic Center, on Friday, November 11 at 3:52 p.m. CST. The primary objective of the Phase 3 trial was to assess
the magnitude of pain relief of Zilretta at 12 weeks against placebo as measured by weekly mean average daily pain (ADP)
scores.
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 are expected to rise with a
predicted increase in OA prevalence, which is expected to affect 67 million Americans by 2030.
Each year, more than five million OA patients in the U.S. receive immediate-release corticosteroid and hyaluronic acid IA
injections for knee pain, but these injections generally provide limited relief, and no alternative injectable therapy has been
approved in more than a decade.
About Zilretta
Zilretta is being investigated as the first intra-articular extended-release, non-opioid treatment for patients with moderate to
severe knee OA pain. Zilretta employs proprietary microsphere technology combining TCA – a commonly administered, short-acting
corticosteroid – with a polymer (PLGA) intended to provide persistent concentrations of drug locally to both amplify the magnitude
and prolong the duration of pain relief.
To date, more than 600 patients have been treated with Zilretta in clinical trials. No drug-related serious adverse events have
been observed in these trials and adverse events have typically been localized, mild and comparable to those observed with
immediate-release TCA and placebo. The data from these trials are consistent with Zilretta providing meaningful and durable pain
relief.
Zilretta is an investigational agent and, as such, has not been approved by the U.S. Food and Drug Administration (FDA) or any
other regulatory agencies.
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 IA injections
for knee OA annually.
Forward-Looking Statements
Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements
relating to expected increases in costs and prevalence 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; competition from alternative
therapies; risks related to 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.
Investor Contact David Carey Lazar Partners LTD T: 212-867-1768 dcarey@lazarpartners.com Media Contact Danielle Lewis Lazar Partners LTD T: 212-843-0211 dlewis@lazarpartners.com Corporate Contact Fred Driscoll Chief Financial Officer Flexion Therapeutics, Inc. T: 781-305-7763 fdriscoll@flexiontherapeutics.com
