Flexion Therapeutics Announces That Analysis From Phase 3 Clinical Trial Of Zilretta™ For Osteoarthritis Of The Knee To Be Presented At AAHKS

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 26 th 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 KneeWhile 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 ZilrettaZilretta 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.

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