- Following intra-articular injection, sustained release of triamcinolone acetonide (TCA) from FX006 maintained therapeutic concentration levels in knee joints of patients through 12 weeks -
- Pharmacokinetic (PK) data support previously completed Phase 2b dose-ranging efficacy trial that demonstrated superior magnitude and duration of pain relief over 12 weeks compared to current standard of care -
These FX006 data represent a six-fold increase in the duration of joint residency compared with immediate-release TCA, which is the current standard of care injectable therapy. It is also noteworthy that a prior PK study of FX006 demonstrated that the peak plasma concentration in the hours following injection was decreased 40-fold relative to immediate-release TCA, a decrease that may meaningfully reduce adverse systemic side effects.
In this multi-center, open-label study of 50 patients with OA of the knee, researchers assigned patients sequentially to one of five groups that received a single IA injection of either 10 or 40 mg of FX006 or 40 mg of immediate-release TCA. Synovial fluid concentrations of drug were measured at 12 weeks in all dose groups and also at 16 and 20 weeks in the FX006 40 mg dose group. At 12 weeks both the FX006 10 mg and 40 mg dose groups had therapeutic concentrations of drug in synovial fluid. In contrast, the 40 mg immediate-release TCA dose group had concentrations of drug that were below the lower limit of quantitation. The FX006 40 mg dose group also demonstrated readily measurable concentrations of drug at 16 weeks, which fell to below the lower limit of quantitation at 20 weeks.
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 of clinical trials, and anticipated clinical and other milestones (including the timing of such milestones), 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 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 possibility that future trial results may not be consistent with past results, the fact that Flexion will require additional capital, including prior to completing Phase 3 development of, filing for regulatory approval for, or 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
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