BURLINGTON, Mass., Nov. 09, 2015 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced financial results for the third quarter ended September 30, 2015.
“We continue to focus on advancing our lead program, Zilretta™ (a potential first-in-class injectable, non-opioid, sustained-release, intra-articular (IA) treatment for patients with moderate to severe osteoarthritis (OA) pain), toward a potential New Drug Application (NDA) filing in the second half of 2016,” said Michael Clayman, M.D., Flexion Therapeutics President and Chief Executive Officer. “During the third quarter, we completed enrollment in our second pivotal trial (a Phase 3 study) and announced top-line data from our pivotal Phase 2b clinical trial, noting that while it did not achieve its primary endpoint, Zilretta™ provided substantial and persistent pain relief compared to placebo and was well-tolerated with a safety profile comparable to placebo. A pre-specified, commonly applied sensitivity analysis (Baseline Observation Carried Forward/Last Observation Carried Forward (BOCF/LOCF)) that addresses patient dropouts, however, did demonstrate statistical significance for the primary endpoint at 12-weeks (p = 0.042) in addition to weeks 1 to 11 and week 13. For reference, we have now posted the BOCF/LOCF data curve on our website at www.flexiontherapeutics.com under Programs and Pipeline/Scientific Presentations. In addition, we have posted the original data curves with error bars to help illustrate the clear separation of the Zilretta™ curve from the placebo curve. Also, we were gratified to receive the notification of allowance for the trademark Zilretta™ from the U.S. PTO.”
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