BURLINGTON, Mass., Sept. 1, 2015 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for FX006, Flexion’s late-stage, lead drug candidate that is designed as a treatment for the more than four million U.S. patients receiving intra-articular (IA) injections for osteoarthritis (OA) of the knee. Flexion is currently studying FX006 in a Phase 2b pivotal trial, with top-line data expected to be announced soon, as well as in a Phase 3 clinical trial for which it expects to share data in the first quarter of 2016.
“We believe FX006 has the potential to provide durable pain relief and become the best-in-class intra-articular treatment for the millions of patients who suffer from knee OA,” stated Michael Clayman, M.D., Flexion Therapeutics’ President and Chief Executive Officer. “It’s encouraging that FX006 has received Fast Track designation from the FDA, which recognizes OA as a serious disease and that FX006 could provide meaningful improvement over existing therapies. We look forward to working closely with the FDA, as we complete our planned New Drug Application (NDA) submission in the second half of 2016.”
The FDA’s Fast Track program was designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Drugs with the Fast Track designation generally qualify for priority review if supported by clinical data at the time of NDA filing, thereby expediting the FDA review process. Additionally, Fast Track designation allows a company to submit completed sections of a related NDA on a rolling basis.
FX006 is a potential first-in-class injectable, sustained-release, IA treatment for patients with moderate to severe knee 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, approximately 600 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, triamcinolone acetonide. 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.
Statements in this press release regarding matters that are not historical facts, including statements relating to the future of Flexion, its ongoing clinical development of its product candidates (including FX006), potential benefits of Fast Track designation, expected timelines related to clinical trials and regulatory filings and potential commercial launch, and 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 Fast Track designation will not eliminate any steps in the FDA approval process and does not guarantee a faster or more favorable review of an NDA, 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.
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