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BURLINGTON, Mass., June 3, 2015 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that a manuscript describing final study results from a completed Phase 2b clinical trial of FX006, an intra-articular (IA) sustained release corticosteroid for the treatment of osteoarthritis (OA), has been published online1 in the Journal of Bone and Joint Surgery (JBJS). The results demonstrate that FX006 provides superior pain relief to the current standard of care in the treatment of OA of the knee. OA of all joints afflicts more than 27 million adults in the U.S. and 100 million worldwide. Flexion is currently studying FX006 in a Phase 3 clinical trial as a treatment for pain associated with OA of the knee as well as in a Phase 2 clinical trial as a potential treatment for OA pain in active military and medically retired veterans with post-traumatic OA of the knee.
Michael Clayman, M.D., Flexion Therapeutics' President and Chief Executive Officer, said, "The publication of our Phase 2b trial results helps to provide important information on FX006 to the medical community, increasing awareness of FX006 as a first-in-class injectable, sustained-release, IA steroid. We are excited about the potential for FX006 and believe it can make a real difference for the many patients who suffer from OA knee pain and are enthusiastically advancing this product."
The clinical trial described in the JBJS manuscript was conducted in the United States, Canada and Australia. Researchers enrolled 228 patients with moderate to severe OA of the knee. Patients were injected with immediate-release triamcinolone acetonide (TCA) (the standard of care) or 10, 40 or 60 mg of study drug FX006. The primary outcome measure was the weekly mean of the average daily pain intensity score assessed using an 11-point numerical rating scale (NRS) where 0 represents no pain and 10 represents the worst pain imaginable. At the 8-week endpoint, the 40 mg dose of FX006 demonstrated a statistically (p= 0.01) and clinically significant improvement relative to immediate-release TCA, and analyses of secondary measures including Western Ontario and McMaster Universities (WOMAC®) pain, stiffness, and function subscales, patient global impression of change and clinician global impression of change also demonstrated statistical superiority. Additionally, the 40 mg dose of FX006 produced pain relief that was improved at Weeks 2-12 and statistically superior to immediate-release TCA at weeks 5-10 (p<0.05 at each time point), and the time-weighted average of pain relief (assessed with NRS intensity scores) was statistically superior to immediate-release TCA over Weeks 1-12 (p=0.04). In summary, the extended residency of drug in the joint with 40 mg of FX006 not only prolonged but also amplified analgesic effect relative to the standard of care.
Neil Bodick, M.D., PhD., Flexion Therapeutics' Chief Medical Officer, noted, "The Journal of Bone and Joint Surgery is among the most highly regarded publications with orthopedists and sports medicine physicians, who are key decision makers in the management of OA patients. These specialists perform approximately 70 percent of all intra-articular knee injections in this patient population."
FX006 is a first-in-class injectable, sustained-release, IA steroid treatment for patients with moderate to severe OA pain. FX006 was specifically designed to address the limitations of current IA therapies by providing long-lasting, local analgesia while avoiding systemic side effects. To date, over 440 patients have been treated with FX006. In a completed Phase 2b dose-ranging clinical trial, FX006 has demonstrated clinically meaningful and significantly better pain relief compared to the current injectable standard of care, TCA. In two Phase 2a synovial fluid pharmacokinetic studies, a single IA injection of FX006 demonstrated therapeutic concentrations of drug in joint fluid for at least 12 weeks. FX006 is currently being studied in pivotal Phase 2b and Phase 3 clinical trials, which are designed to provide the required data for FX006 to be submitted for regulatory approval by the U.S. Food and Drug Administration.
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.
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 (including FX006), 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 past clinical trial results may not be predictive of results in future 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, 2014 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.
1 Bodick, N., et al. (2015) An Intra-Articular, Extended-Release Formulation of Triamcinolone Acetonide Prolongs and Amplifies Analgesic Effect in Patients with Osteoarthritis of the Knee. J Bone Joint Surg Am. 2015;97:877-88 d http://dx.doi.org/10.2106/JBJS.N.00918.
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