BURLINGTON, MASS., September 01, 2015 – 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.