World News: 21:05 GMT Monday 11th February 2019. [Flexion Therapeutics, Inc. via Globe Newswire via SPi World News]
BURLINGTON, Mass., Feb. 11, 2019 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the results from an open-label Phase 3b clinical trial evaluating the safety and exploratory efficacy of repeat administration of ZILRETTA (triamcinolone acetonide extended-release injectable suspension) in patients with osteoarthritis (OA) of the knee were published in . The data indicate that repeat administration of ZILRETTA was generally safe and well-tolerated. In addition, an analysis of radiographs (X-rays) taken at baseline and Week 52 showed ZILRETTA had no deleterious effects on cartilage or joint structure. The data also indicate that the magnitude and duration of pain relief experienced by patients after both the first and second injections was similar to the clinical benefit of ZILRETTA in the pivotal on which the FDA approval of ZILRETTA was based. The repeat administration study is the first to evaluate the effect of ZILRETTA in patients with the most advanced radiographic knee OA (Kellgren-Lawrence grade 4), demonstrating similar benefit compared to those with less advanced disease (KL-2 and 3).
“This valuable study suggests that repeat administration of ZILRETTA can provide patients suffering from knee OA consistent, substantial, and durable pain relief, and is generally well-tolerated. Importantly, analysis of the X-ray data showed no impact on cartilage or any other negative structural impact at one-year follow-up,” said Andrew Spitzer, M.D., Co-Director, Joint Replacement Program, Cedars-Sinai Orthopaedic Center. “Because OA knee pain can be chronic and debilitating, patients need treatments that can provide extended and effective relief. The data published in suggest that ZILRETTA can play an integral role in helping patients manage recurring OA knee pain.”
Key topline results from the Phase 3 trial:
“We are excited to have these data published in a peer-reviewed journal, as they provide meaningful clinical evidence that repeat administration of ZILRETTA appears to provide safe and effective pain relief for the millions of people who confront ongoing pain from OA of the knee,” explained Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “In December, we provided the full data set from this repeat administration trial to the FDA as part of a supplemental New Drug Application (sNDA), and we look forward to working with the Agency as they conduct their review.”
Participants received an initial intra-articular injection of ZILRETTA followed by evaluation at Weeks 12, 16, 20 and 24 to determine their eligibility for a second injection. A second dose was administered only when patients reported they were ready for additional treatment (based on pain levels) and their physician agreed it was clinically indicated. Clinical benefit was measured through validated instruments including the WOMAC questionnaire that evaluates a patient’s pain, stiffness and function, and the Knee Injury and Osteoarthritis Outcome Score-Quality of Life scale.
Scott YoungVice President, Corporate Communications & Investor RelationsFlexion Therapeutics, Inc.T: firstname.lastname@example.org
Julie DownsManager, Corporate CommunicationsFlexion Therapeutics, Inc.T: email@example.com
Globe Newswire: 21:05 GMT Monday 11th February 2019
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