Flexion Therapeutics Initiates Phase 3 Clinical Trial of FX006 in Patients With Osteoarthritis of the Knee
BURLINGTON, Mass., Feb. 2, 2015 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced dosing of the first patient in the Phase 3 clinical trial of its lead drug candidate FX006 as a treatment for pain associated with osteoarthritis (OA) of the knee. FX006 is Flexion's novel, non-opioid, sustained-release, intra-articular (IA or within the joint) formulation of triamcinolone acetonide (TCA). FX006 is designed for patients with moderate to severe OA pain and is intended to provide substantial and persistent pain relief while avoiding systemic side effects.
"The successful performance of our lead drug candidate FX006 in our completed Phase 2b dose-ranging trial is encouraging. The demonstrated superiority to the current standard of care in that trial shows the potential FX006 has to make a difference for patients suffering from pain due to OA of the knee," said Michael Clayman, M.D., President and CEO of Flexion Therapeutics. "We look forward to topline data from our current pivotal Phase 2b trial against placebo in the second half of 2015 and to these Phase 3 comparative results of FX006 against the current standard of care (immediate-release TCA) and against placebo in 2016. We expect that data from these pivotal trials, if positive, will lead us to submit a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for FX006 in 2016."
About the Phase 3 Trial of FX006 in OA of the Knee
The newly initiated randomized, double-blind Phase 3 trial will take place at about 60 centers worldwide. Approximately 450 patients will be randomized to one of three treatment groups (1:1:1) and treated with a single IA injection of either saline (placebo) or 40 mg of FX006 or 40 mg of TCA. Each patient will be evaluated for efficacy and safety at 7 outpatient visits over 24 weeks after receiving an injection. The primary objective of this study is to assess the magnitude and duration of pain relief of FX006 at 12 weeks against placebo. The secondary objectives of this study are to assess the effect of FX006 on the magnitude and duration of pain relief relative to immediate-release TCA and the effect of FX006 on function, responder status, global impressions of change, stiffness and consumption of analgesic medications relative to both controls. The current pivotal Phase 2b trial and the newly initiated Phase 3 trial are designed to provide the required data for FX006 to be submitted for regulatory approval by the FDA.
About Flexion Therapeutics
Flexion is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel pain therapies. The company is currently advancing a portfolio of injectable drug candidates that have the potential to provide better and more persistent analgesia compared with existing therapy. The company's lead program, FX006, is an intra-articular sustained-release steroid in development for patients with moderate to severe OA pain. The company also has two additional product candidates, FX007, a locally administered TrkA receptor antagonist for post-operative pain, and FX005, an intra-articular, sustained-release p38 MAP kinase inhibitor for end-stage OA patients.
Statements in this press release regarding matters that are not historical facts, including statements relating to the future of Flexion, its ongoing development of its product candidates, expected design, timing and results of the on-going Phase 2b and Phase 3 clinical trials, plans and timing for regulatory submissions, anticipated clinical and other milestones (including the timing of such milestones) and potential benefits of FX006 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 and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics, the fact that results of past clinical trials may not be predictive of subsequent trials, the fact that Flexion relies on third parties to manufacture and conduct the clinical trials of its product candidates, which could delay or limit their future development or regulatory approval, the fact that Flexion will require additional capital, including prior to commercializing FX006 or any of its other product candidates, and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to it, and other risks and uncertainties described in Flexion's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Flexion's Annual Report on Form 10-K for the year ended December 31, 2013 and subsequent filings with the SEC. You are encouraged to read Flexion's filings with the SEC, available at www.sec.gov/, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this press release, and Flexion undertakes no obligation to update or revise any of the statements.
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