BURLINGTON, Mass., Feb. 24, 2015 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced today that it has completed enrollment in its pivotal Phase 2b confirmatory clinical trial designed to further evaluate the safety, tolerability and efficacy of FX006 as a treatment for relieving pain associated with OA of the knee. FX006 is Flexion's novel, non-opioid, sustained-release, intra-articular (IA) formulation of triamcinolone acetonide (TCA). It is currently in a Phase 3 clinical trial and is designed to provide prolonged pain relief for the treatment of mild to moderate OA of the knee, while avoiding untoward systemic effects associated with immediate-release steroids.
Michael Clayman, M.D., Flexion Therapeutics President and Chief Executive Officer, said, "This Phase 2b confirmatory clinical trial is powered to provide pivotal data for FX006 compared to placebo. These data, if positive, in addition to those that will come from the recently initiated Phase 3 clinical trial, will form the basis for FX006 to be submitted in 2016 for regulatory approval by the U.S. Food & Drug Administration (FDA)."
The pivotal Phase 2b confirmatory clinical trial is a double blind, randomized study of 310 patients who were treated with a single injection of either 20 mg or 40 mg of FX006, or placebo. The primary outcome measure is the weekly mean of the average daily pain intensity scores as assessed using an 11-point numerical rating scale (NRS). Pain relief will be characterized over 24 weeks with the primary endpoint at 12 weeks. Secondary endpoints include Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) pain, stiffness and function, patient global impression of change, clinical global impression of change and responder status.
Flexion expects to announce topline results from this pivotal Phase 2b confirmatory clinical trial in the fourth quarter of 2015.
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 local, 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.
Forward-Looking Statements
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 ongoing Phase 2b and ongoing 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.